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NCT04802161 · OUTCOME

Incidence of Adverse Events

Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes · Source last updated 2026-06-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 30 days after last dose, up to 2 years

What was measured

Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 and compared descriptively between Arms A and B. Serious adverse events are denoted by "\[SAE\]".

Groups in this outcome

Safety Run In DL1 (14 Days Pomalidomide)

Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 14 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy Liposome-encapsulated Daunorubicin-Cytarabine: Given IV Pomalidomide: Given PO

Safety Run In DL-1 (10 Days Pomalidomide)

Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 10 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy Liposome-encapsulated Daunorubicin-Cytarabine: Given IV Pomalidomide: Given PO

Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)

INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 14 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy Liposome-encapsulated Daunorubicin-Cytarabine: Given IV Pomalidomide: Given PO

Arm B (Daunorubicin and Cytarabine Liposome)

INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy Liposome-encapsulated Daunorubicin-Cytarabine: Given IV

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Safety Run In DL1 (14 Days Pomalidomide)7
Safety Run In DL-1 (10 Days Pomalidomide)3
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)20
Arm B (Daunorubicin and Cytarabine Liposome)19

Reported measurements

Alanine Aminotransferase Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)8Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)8Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)6Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)8Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)8Not reportedNot reportedNot reportedNot reported
Abdominal Distension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Activated Partial Thromboplastin Time Prolonged
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Acute Kidney Injury
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)7Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)4Not reportedNot reportedNot reportedNot reported
Alkalosis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Allergic Reaction
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Alopecia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Anal fissure
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Anal Fistula
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Atrial Flutter
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Back Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Bacteremia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)5Not reportedNot reportedNot reportedNot reported
Bloating
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Blood Bicarbonate Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Blood Bilirubin Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)6Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)3Not reportedNot reportedNot reportedNot reported
Blood/Lymph - Other - D Dimer increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Blood/Lymph - Other - Increased Fibrinogen
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Blood/Lymph - Other - PT increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Blood/Lymph - Other - febrile non-hemolytic transfusion reaction (FNHTR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Blood/Lymph - Other - petechiae
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
Burred Vision
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)3Not reportedNot reportedNot reportedNot reported
Bone Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Bruising
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Cardiac Troponin I Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Catheter Related Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Chest Wall Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Chills
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
Chronic Kidney Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Confusion
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Constipation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)12Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)10Not reportedNot reportedNot reportedNot reported
Cough
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)7Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)5Not reportedNot reportedNot reportedNot reported
Creatinine Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)3Not reportedNot reportedNot reportedNot reported
Cytokine Release Syndrome
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Disseminated Intravascular Coagulation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
Dehydration
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
Delirium
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Delusions
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Depression
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Diarrhea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)6Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)4Not reportedNot reportedNot reportedNot reported
Dizziness
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)4Not reportedNot reportedNot reportedNot reported
Dry Mouth
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Dysgeusia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
Dyspepsia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Dysphagia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Dyspnea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)9Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
EKG QT Corrected Interval Prolong
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Ear and Labyrinth - Other - Serous otitis media
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Ear Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Edema Face
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Edema Limbs
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)8Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)6Not reportedNot reportedNot reportedNot reported
Elevated Lactate Dehydrogenase (LDH)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)4Not reportedNot reportedNot reportedNot reported
Eosinophilia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Epistaxis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)5Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)6Not reportedNot reportedNot reportedNot reported
Esophageal Hemorrhage
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Extrapyramidal Disorder
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Fall
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Fatigue
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)8Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)6Not reportedNot reportedNot reportedNot reported
Febrile Neutropenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)8Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)4Not reportedNot reportedNot reportedNot reported
Fever
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)4Not reportedNot reportedNot reportedNot reported
Fibrinogen Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Flatulence
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
Floaters
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Flushing
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Folliculitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Gamma-Glutamyl Transferase (GGT) Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
GI disorders - Other, specify - Black lesion on tongue
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
GI disorders - Other, specify - Bright red blood per rectum
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
GI disorders - Other, specify - Diverticulitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
GI disorders - Other, specify - Gastrointestinal bleeding
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
GI disorders - Other, specify - Genitourinary bleeding
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
GI disorders - Other, specify - Gum Bleeding
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
GI disorders - Other, specify - Lip lesion
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
GI disorders - Other, specify - Lower GI hemmorrage
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
GI disorders - Other, specify - Melena
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
GI disorders - Other, specify - Rectal bleeding
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
GI disorders - Other, specify - Wet Purpura
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
GI disorders - Other, specify - hematochezia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Gastroesophageal reflux disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Gastrointestinal Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Generalized Edema
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Generalized Muscle Weakness
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Genital Edema
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Headache
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)5Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)7Not reportedNot reportedNot reportedNot reported
Hearing Impaired
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Heart Failure
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Hematoma
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Hematuria
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
Hemorrhoidal Hemorrhage
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Hemorrhoids
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Hoarseness
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Hypercalcemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Hyperglycemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)6Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)6Not reportedNot reportedNot reportedNot reported
Hyperhidrosis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Hyperkalemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Hypermagnesemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
Hypernatremia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Hyperphosphatemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)5Not reportedNot reportedNot reportedNot reported
Hypertension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)5Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)6Not reportedNot reportedNot reportedNot reported
Hyperuricemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)7Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)12Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)14Not reportedNot reportedNot reportedNot reported
Hypocalcemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)8Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)9Not reportedNot reportedNot reportedNot reported
Hypokalemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)6Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)10Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)11Not reportedNot reportedNot reportedNot reported
Hypomagnesemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)3Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)7Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)10Not reportedNot reportedNot reportedNot reported
Hypophosphatemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)5Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)4Not reportedNot reportedNot reportedNot reported
Hypotension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)3Not reportedNot reportedNot reportedNot reported
Hypoxia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
International Normalized Ratio (INR) Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Infections & infestations - Other - Pediculosis captis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Infections & infestations - Other - Sars-COV-2
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Infections & infestations - Other - Sepsis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Infusion Related Reaction
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Injury/poison/procedure - Other - Acute RLE DVT
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Injury/poison/procedure - Other - Acute RUE VTE (superficial and deep)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Injury/poison/procedure - Other - Central line incision site erythema
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Injury/poison/procedure - Other - L maxillary anterior, medial, posterior wall fracture
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Injury/poison/procedure - Other - L nasal dorsum laceration
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Injury/poison/procedure - Other - Left lateral orbital wall fracture
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Injury/poison/procedure - Other - R orbital roof/lateral orbital wall fracture
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Injury/poison/procedure - Other - Septal fracture
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Injury/poison/procedure - Other - bilateral nasal bone fracture
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Injury/poison/procedure - Other - left frontal bone fracture
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Injury/poison/procedure - Other - left inferior orbital wall fracture
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Injury/poison/procedure - Other - left supraorbital laceration
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Insomnia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)5Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)5Not reportedNot reportedNot reportedNot reported
Investigations - Other, specify - Hyperfibrinogenemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Investigations - Other, specify - Increased Fibrinogen
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Investigations - Other, specify - increased chloride
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Localized Edema
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Lung Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)5Not reportedNot reportedNot reportedNot reported
Lymph Node Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Lymphocyte Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)5Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)12Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)13Not reportedNot reportedNot reportedNot reported
Lymphocyte Count Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Mucositis Oral
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)9Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)5Not reportedNot reportedNot reportedNot reported
Muscle Cramp
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Muscle Weakness Upper Limb
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Musculoskel/connect tissue -Other - Blanchable tissue (Buttocks)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Musculoskel/connect tissue -Other - Deep tissue injury (buttocks)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Musculoskel/connect tissue -Other - Pain in LLE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Musculoskel/connect tissue -Other - vastus lateralis muscle strain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Myalgia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
Nasal Congestion
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)6Not reportedNot reportedNot reportedNot reported
Nausea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)6Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)8Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)8Not reportedNot reportedNot reportedNot reported
Neck Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Nervous system - Other - Anomia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Nervous system - Other - Rigors
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Neutrophil Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)7Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)11Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)11Not reportedNot reportedNot reportedNot reported
Non-cardiac Chest Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Oral Hemorrhage
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Oral Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)5Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)6Not reportedNot reportedNot reportedNot reported
Pain in Extremity
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)4Not reportedNot reportedNot reportedNot reported
Papulopustular Rash
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Paresthesia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Pericardial Effusion
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Periodontal Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Peripheral Motor Neuropathy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Peripheral Sensory Neuropathy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
Pharyngitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Platelet Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)7Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)16Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)12Not reportedNot reportedNot reportedNot reported
Pleural Effusion
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)5Not reportedNot reportedNot reportedNot reported
Pleuritic Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Presyncope
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Proctitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Productive Cough
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Proteinuria
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Pruritus
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)6Not reportedNot reportedNot reportedNot reported
Pulmonary Edema
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Pulmonary Hypertension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Purpura
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Rash Maculo-papular
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)8Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)8Not reportedNot reportedNot reportedNot reported
Rectal Hemorrhage
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Rectal Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)3Not reportedNot reportedNot reportedNot reported
Resp, thoracic & mediast - Other - Hemoptysis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Resp, thoracic & mediast - Other - Nasal dryness
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Resp, thoracic & mediast - Other - Nasal irritation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Respiratory Failure
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Restlessness
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Retinal Tear
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Rhinorrhea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Scrotal Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Sepsis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Sinus Bradycardia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Sinus Tachycardia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Skin & subcutaneous tissue -Other - Actinic Keratosis Reaction
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Skin & subcutaneous tissue -Other - Back Lesion
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Skin & subcutaneous tissue -Other - Erythema around line insertion
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Skin & subcutaneous tissue -Other - L Ankle lesion
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Skin & subcutaneous tissue -Other - L skin lesion (Wrist)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Skin & subcutaneous tissue -Other - Petechial rash
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Skin & subcutaneous tissue -Other - Purulence at site of prior picc line
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Skin & subcutaneous tissue -Other - R leg nodules
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Skin & subcutaneous tissue -Other - R leg subcu nodules
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Skin & subcutaneous tissue -Other - Right neck rash
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Skin & subcutaneous tissue -Other - nodule
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Skin Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)3Not reportedNot reportedNot reportedNot reported
Soft Tissue Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Sore Throat
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Supraventricular Tachycardia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Thromboembolic Event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Thrush
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
Tremor
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Typhlitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Upper Gastrointestinal Hemorrhage
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Upper Respiratory Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Urinary Frequency
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Urinary Incontinence
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Urinary Retention
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Urinary Urgency
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
Vaginal Hemorrhage
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Vaginal Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Vascular Access Complication
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)8Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)9Not reportedNot reportedNot reportedNot reported
Ventricular Arrhythmia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Vomiting
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)6Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)4Not reportedNot reportedNot reportedNot reported
Weight Gain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
Weight Loss
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
Wheezing
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
White Blood Cell Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)5Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)16Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)14Not reportedNot reportedNot reportedNot reported
[SAE] Alanine Aminotransferase (ALT) Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
[SAE] Acute Respiratory Distress Syndrome (ARDS)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Aspartate Aminotransferase (AST) Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)3Not reportedNot reportedNot reportedNot reported
[SAE] Abdominal Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Activated Partial Thromboplastin Time (PTT) Prolonged
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Acute Kidney Injury
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Alkaline phosphatase increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Anemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)7Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)13Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)11Not reportedNot reportedNot reportedNot reported
[SAE] Anorexia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Anxiety
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
[SAE] Atrial Fibrillation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Atrial Flutter
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Blood Bilirubin Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Cardiac Arrest
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Catheter Related Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Creatinine Incrased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Delirium
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Disease Progression
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Dyspnea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
[SAE] EKG QT corrected interval prolong
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Eosinophilia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Epistaxis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
[SAE] Eye disorders - Other, specify - Right eye vision lost
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Fall
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
[SAE] Fatigue
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Febrile Neutropenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)5Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)14Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)16Not reportedNot reportedNot reportedNot reported
[SAE] GI disorders - Other, specify - Diverticulitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] GI disorders - Other, specify - melena
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Heart Failure
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Hematuria
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Hyperkalemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Hypertension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)5Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)4Not reportedNot reportedNot reportedNot reported
[SAE] Hypoalbuminemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
[SAE] Hypocalcemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Hypokalemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)4Not reportedNot reportedNot reportedNot reported
[SAE] Hypotension
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
[SAE] Hypoxia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)8Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
[SAE] Infections & infestations - Other - Sepsis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
[SAE] Lung Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)4Not reportedNot reportedNot reportedNot reported
[SAE] Lymphocyte Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)4Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)11Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)12Not reportedNot reportedNot reportedNot reported
[SAE] Lymphocyte Count Increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Nausea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Neutrophil Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)7Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)12Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)11Not reportedNot reportedNot reportedNot reported
[SAE] Platelet Count Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)7Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)17Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)13Not reportedNot reportedNot reportedNot reported
[SAE] Pleural Effusion
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
[SAE] Pulmonary Edema
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
[SAE] Rash Maculo-papular
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
[SAE] Rectal Pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
[SAE] Renal Calculi
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Respiratory Failure
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Seizure
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Sepsis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Sinus Bradycardia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Sinusitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Skin Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)2Not reportedNot reportedNot reportedNot reported
[SAE] Soft Tissue Infection
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
[SAE] Supraventricular Tachycardia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
[SAE] Syncope
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
[SAE] Typhlitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Upper Gastrointestinal Hemorrhage
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Urinary Retention
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] Vascular Access Complication
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)2Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)1Not reportedNot reportedNot reportedNot reported
[SAE] Vomiting
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)1Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)0Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)0Not reportedNot reportedNot reportedNot reported
[SAE] White Blood Cell Decreased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Run In DL1 (14 Days Pomalidomide)6Not reportedNot reportedNot reportedNot reported
Safety Run In DL-1 (10 Days Pomalidomide)3Not reportedNot reportedNot reportedNot reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)16Not reportedNot reportedNot reportedNot reported
Arm B (Daunorubicin and Cytarabine Liposome)15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        8
    title
    Alanine Aminotransferase Increased
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        8
    title
    Aspartate Aminotransferase Increased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
    title
    Abdominal Distension
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
    title
    Activated Partial Thromboplastin Time Prolonged
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
    title
    Acute Kidney Injury
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        7
      4. group Id
        OG003
        value
        4
    title
    Alkaline Phosphatase Increased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Alkalosis
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Allergic Reaction
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
    title
    Alopecia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
    title
    Anal fissure
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
    title
    Anal Fistula
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        0
    title
    Atrial Flutter
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      20
    4. group Id
      OG003
      value
      19
    units
    Participants
description
Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 and compared descriptively between Arms A and B. Serious adverse events are denoted by "\[SAE\]".
groups
  1. description
    Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 14 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy Liposome-encapsulated Daunorubicin-Cytarabine: Given IV Pomalidomide: Given PO
    id
    OG000
    title
    Safety Run In DL1 (14 Days Pomalidomide)
  2. description
    Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 10 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy Liposome-encapsulated Daunorubicin-Cytarabine: Given IV Pomalidomide: Given PO
    id
    OG001
    title
    Safety Run In DL-1 (10 Days Pomalidomide)
  3. description
    INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 and then pomalidomide PO QD beginning between days 21-30 for 14 days in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy Liposome-encapsulated Daunorubicin-Cytarabine: Given IV Pomalidomide: Given PO
    id
    OG002
    title
    Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
  4. description
    INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
    id
    OG003
    title
    Arm B (Daunorubicin and Cytarabine Liposome)
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 30 days after last dose, up to 2 years
title
Incidence of Adverse Events
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice