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
Group
Source 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
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
8
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
8
Not reported
Not reported
Not reported
Not reported
Aspartate Aminotransferase Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
6
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
8
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
8
Not reported
Not reported
Not reported
Not reported
Abdominal Distension
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Activated Partial Thromboplastin Time Prolonged
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Acute Kidney Injury
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Alkaline Phosphatase Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
7
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
4
Not reported
Not reported
Not reported
Not reported
Alkalosis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Allergic Reaction
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Alopecia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Anal fissure
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Anal Fistula
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Atrial Flutter
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Back Pain
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Bacteremia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
5
Not reported
Not reported
Not reported
Not reported
Bloating
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Blood Bicarbonate Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Blood Bilirubin Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
6
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
3
Not reported
Not reported
Not reported
Not reported
Blood/Lymph - Other - D Dimer increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Blood/Lymph - Other - Increased Fibrinogen
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Blood/Lymph - Other - PT increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Blood/Lymph - Other - febrile non-hemolytic transfusion reaction (FNHTR)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Blood/Lymph - Other - petechiae
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
Burred Vision
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
3
Not reported
Not reported
Not reported
Not reported
Bone Pain
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Bruising
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Cardiac Troponin I Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Catheter Related Infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Chest Wall Pain
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Chills
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
Chronic Kidney Disease
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Confusion
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Constipation
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
12
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
10
Not reported
Not reported
Not reported
Not reported
Cough
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
7
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
5
Not reported
Not reported
Not reported
Not reported
Creatinine Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
3
Not reported
Not reported
Not reported
Not reported
Cytokine Release Syndrome
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Disseminated Intravascular Coagulation
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
Dehydration
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
Delirium
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Delusions
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Depression
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Diarrhea
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
6
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
4
Not reported
Not reported
Not reported
Not reported
Dizziness
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
4
Not reported
Not reported
Not reported
Not reported
Dry Mouth
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Dysgeusia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
Dyspepsia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Dysphagia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Dyspnea
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
9
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
EKG QT Corrected Interval Prolong
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Ear and Labyrinth - Other - Serous otitis media
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Ear Pain
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Edema Face
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Edema Limbs
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
8
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
6
Not reported
Not reported
Not reported
Not reported
Elevated Lactate Dehydrogenase (LDH)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
4
Not reported
Not reported
Not reported
Not reported
Eosinophilia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Epistaxis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
5
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
6
Not reported
Not reported
Not reported
Not reported
Esophageal Hemorrhage
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Extrapyramidal Disorder
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Fall
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Fatigue
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
8
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
6
Not reported
Not reported
Not reported
Not reported
Febrile Neutropenia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
8
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
4
Not reported
Not reported
Not reported
Not reported
Fever
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
4
Not reported
Not reported
Not reported
Not reported
Fibrinogen Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Flatulence
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
Floaters
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Flushing
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Folliculitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Gamma-Glutamyl Transferase (GGT) Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
GI disorders - Other, specify - Black lesion on tongue
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
GI disorders - Other, specify - Bright red blood per rectum
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
GI disorders - Other, specify - Diverticulitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
GI disorders - Other, specify - Gastrointestinal bleeding
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
GI disorders - Other, specify - Genitourinary bleeding
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
GI disorders - Other, specify - Gum Bleeding
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
GI disorders - Other, specify - Lip lesion
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
GI disorders - Other, specify - Lower GI hemmorrage
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
GI disorders - Other, specify - Melena
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
GI disorders - Other, specify - Rectal bleeding
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
GI disorders - Other, specify - Wet Purpura
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
GI disorders - Other, specify - hematochezia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Gastroesophageal reflux disease
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Gastrointestinal Pain
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Generalized Edema
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Generalized Muscle Weakness
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Genital Edema
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Headache
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
5
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
7
Not reported
Not reported
Not reported
Not reported
Hearing Impaired
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Heart Failure
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Hematoma
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Hematuria
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
Hemorrhoidal Hemorrhage
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Hemorrhoids
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Hoarseness
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Hypercalcemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Hyperglycemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
6
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
6
Not reported
Not reported
Not reported
Not reported
Hyperhidrosis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Hyperkalemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Hypermagnesemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
Hypernatremia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Hyperphosphatemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
5
Not reported
Not reported
Not reported
Not reported
Hypertension
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
5
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
6
Not reported
Not reported
Not reported
Not reported
Hyperuricemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Hypoalbuminemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
7
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
12
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
14
Not reported
Not reported
Not reported
Not reported
Hypocalcemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
8
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
9
Not reported
Not reported
Not reported
Not reported
Hypokalemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
6
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
10
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
11
Not reported
Not reported
Not reported
Not reported
Hypomagnesemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
3
Not reported
Not reported
Not reported
Not reported
Hyponatremia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
7
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
10
Not reported
Not reported
Not reported
Not reported
Hypophosphatemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
5
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
4
Not reported
Not reported
Not reported
Not reported
Hypotension
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
3
Not reported
Not reported
Not reported
Not reported
Hypoxia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
International Normalized Ratio (INR) Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Infections & infestations - Other - Pediculosis captis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Infections & infestations - Other - Sars-COV-2
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Infections & infestations - Other - Sepsis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Infusion Related Reaction
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Injury/poison/procedure - Other - Acute RLE DVT
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Injury/poison/procedure - Other - Acute RUE VTE (superficial and deep)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Injury/poison/procedure - Other - Central line incision site erythema
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Injury/poison/procedure - Other - L maxillary anterior, medial, posterior wall fracture
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Injury/poison/procedure - Other - L nasal dorsum laceration
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Injury/poison/procedure - Other - Left lateral orbital wall fracture
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Injury/poison/procedure - Other - R orbital roof/lateral orbital wall fracture
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Injury/poison/procedure - Other - Septal fracture
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Injury/poison/procedure - Other - bilateral nasal bone fracture
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Injury/poison/procedure - Other - left frontal bone fracture
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Injury/poison/procedure - Other - left inferior orbital wall fracture
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Injury/poison/procedure - Other - left supraorbital laceration
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Insomnia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Skin & subcutaneous tissue -Other - Purulence at site of prior picc line
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Skin & subcutaneous tissue -Other - R leg nodules
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Skin & subcutaneous tissue -Other - R leg subcu nodules
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Skin & subcutaneous tissue -Other - Right neck rash
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Skin & subcutaneous tissue -Other - nodule
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Skin Infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
3
Not reported
Not reported
Not reported
Not reported
Soft Tissue Infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Sore Throat
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Supraventricular Tachycardia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Thromboembolic Event
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Thrush
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
Tremor
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Typhlitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Upper Gastrointestinal Hemorrhage
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Upper Respiratory Infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Urinary Frequency
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Urinary Incontinence
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Urinary Retention
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Urinary Urgency
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
Vaginal Hemorrhage
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Vaginal Pain
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Vascular Access Complication
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
8
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
9
Not reported
Not reported
Not reported
Not reported
Ventricular Arrhythmia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Vomiting
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
6
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
4
Not reported
Not reported
Not reported
Not reported
Weight Gain
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
Weight Loss
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
Wheezing
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
White Blood Cell Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
5
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
16
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
14
Not reported
Not reported
Not reported
Not reported
[SAE] Alanine Aminotransferase (ALT) Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
[SAE] Acute Respiratory Distress Syndrome (ARDS)
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Aspartate Aminotransferase (AST) Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
3
Not reported
Not reported
Not reported
Not reported
[SAE] Abdominal Pain
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Activated Partial Thromboplastin Time (PTT) Prolonged
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Acute Kidney Injury
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Alkaline phosphatase increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Anemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
7
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
13
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
11
Not reported
Not reported
Not reported
Not reported
[SAE] Anorexia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Anxiety
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
[SAE] Atrial Fibrillation
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Atrial Flutter
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Blood Bilirubin Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Cardiac Arrest
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Catheter Related Infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Creatinine Incrased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Delirium
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Disease Progression
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Dyspnea
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
[SAE] EKG QT corrected interval prolong
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Eosinophilia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Epistaxis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
[SAE] Eye disorders - Other, specify - Right eye vision lost
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Fall
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
[SAE] Fatigue
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Febrile Neutropenia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
5
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
14
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
16
Not reported
Not reported
Not reported
Not reported
[SAE] GI disorders - Other, specify - Diverticulitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] GI disorders - Other, specify - melena
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Heart Failure
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Hematuria
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Hyperkalemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Hypertension
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
5
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
4
Not reported
Not reported
Not reported
Not reported
[SAE] Hypoalbuminemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
[SAE] Hypocalcemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Hypokalemia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
4
Not reported
Not reported
Not reported
Not reported
[SAE] Hypotension
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
[SAE] Hypoxia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
8
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
[SAE] Infections & infestations - Other - Sepsis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
[SAE] Lung Infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
4
Not reported
Not reported
Not reported
Not reported
[SAE] Lymphocyte Count Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
4
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
11
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
12
Not reported
Not reported
Not reported
Not reported
[SAE] Lymphocyte Count Increased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Nausea
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Neutrophil Count Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
7
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
12
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
11
Not reported
Not reported
Not reported
Not reported
[SAE] Platelet Count Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
7
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
17
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
13
Not reported
Not reported
Not reported
Not reported
[SAE] Pleural Effusion
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
[SAE] Pulmonary Edema
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
[SAE] Rash Maculo-papular
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
[SAE] Rectal Pain
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
[SAE] Renal Calculi
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Respiratory Failure
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Seizure
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Sepsis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Sinus Bradycardia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Sinusitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Skin Infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
2
Not reported
Not reported
Not reported
Not reported
[SAE] Soft Tissue Infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
[SAE] Supraventricular Tachycardia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
[SAE] Syncope
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
[SAE] Typhlitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Upper Gastrointestinal Hemorrhage
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Urinary Retention
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] Vascular Access Complication
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
2
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
1
Not reported
Not reported
Not reported
Not reported
[SAE] Vomiting
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
1
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
0
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
0
Not reported
Not reported
Not reported
Not reported
[SAE] White Blood Cell Decreased
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Safety Run In DL1 (14 Days Pomalidomide)
6
Not reported
Not reported
Not reported
Not reported
Safety Run In DL-1 (10 Days Pomalidomide)
3
Not reported
Not reported
Not reported
Not reported
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
16
Not reported
Not reported
Not reported
Not reported
Arm B (Daunorubicin and Cytarabine Liposome)
15
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
2
group Id
OG002
value
8
group Id
OG003
value
8
title
Alanine Aminotransferase Increased
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
2
group Id
OG002
value
8
group Id
OG003
value
8
title
Aspartate Aminotransferase Increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Abdominal Distension
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
2
group Id
OG003
value
0
title
Activated Partial Thromboplastin Time Prolonged
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Acute Kidney Injury
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
2
group Id
OG002
value
7
group Id
OG003
value
4
title
Alkaline Phosphatase Increased
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Alkalosis
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Allergic Reaction
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Alopecia
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Anal fissure
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
title
Anal Fistula
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
title
Atrial Flutter
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
3
group Id
OG002
value
20
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
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)
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)
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)
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