NCT04802161 · ADVERSE EVENTS

Adverse events

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

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

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Up to 30 days after last dose, up to 2 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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	7 / 7	7 / 7	3 / 7
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	3 / 3	3 / 3	2 / 3
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	19 / 20	20 / 20	11 / 20
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	19 / 19	18 / 19	7 / 19

Group identifiers: EG000: Safety Run In DL1 (14 Days Pomalidomide) · EG001: Safety Run In DL-1 (10 Days Pomalidomide) · EG002: Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide) · EG003: Arm B (Daunorubicin and Cytarabine Liposome)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
3
group Id
EG001
num Affected
1
num At Risk
3
num Events
3
group Id
EG002
num Affected
2
num At Risk
20
num Events
3
group Id
EG003
num Affected
1
num At Risk
19
num Events
2
term
Alanine Aminotransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Acute Respiratory Distress Syndrome (ARDS)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
4
group Id
EG001
num Affected
1
num At Risk
3
num Events
3
group Id
EG002
num Affected
2
num At Risk
20
num Events
10
group Id
EG003
num Affected
3
num At Risk
19
num Events
3
term
Aspartate Aminotransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Activated Partial Thromboplastin Time Prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
2
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Acute Kidney Injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
2
num At Risk
20
num Events
2
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Alkaline Phosphatase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
7
num At Risk
7
num Events
60
group Id
EG001
num Affected
3
num At Risk
3
num Events
21
group Id
EG002
num Affected
13
num At Risk
20
num Events
76
group Id
EG003
num Affected
11
num At Risk
19
num Events
49
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
1
num At Risk
19
num Events
6
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
20
num Events
2
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Atrial Flutter

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
17
group Id
EG001
num Affected
2
num At Risk
3
num Events
10
group Id
EG002
num Affected
8
num At Risk
20
num Events
24
group Id
EG003
num Affected
8
num At Risk
19
num Events
27
term
Alanine Aminotransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
6
num At Risk
7
num Events
25
group Id
EG001
num Affected
2
num At Risk
3
num Events
16
group Id
EG002
num Affected
8
num At Risk
20
num Events
34
group Id
EG003
num Affected
8
num At Risk
19
num Events
36
term
Aspartate Aminotransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
1
num At Risk
3
num Events
2
group Id
EG002
num Affected
6
num At Risk
20
num Events
12
group Id
EG003
num Affected
1
num At Risk
19
num Events
1
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
20
num Events
2
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Activated Partial Thromboplastin Time Prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Acute Kidney Injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
10
group Id
EG001
num Affected
2
num At Risk
3
num Events
15
group Id
EG002
num Affected
7
num At Risk
20
num Events
18
group Id
EG003
num Affected
4
num At Risk
19
num Events
9
term
Alkaline Phosphatase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Alkalosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Allergic Reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
2
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Anal Fissure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
1
num At Risk
19
num Events
2
term
Anal Fistula

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
7
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
EG000
other Num Affected
7
other Num At Risk
7
serious Num Affected
7
serious Num At Risk
7
title
Safety Run In DL1 (14 Days Pomalidomide)
deaths Num Affected
2
deaths Num At Risk
3
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
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Safety Run In DL-1 (10 Days Pomalidomide)
deaths Num Affected
11
deaths Num At Risk
20
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
EG002
other Num Affected
20
other Num At Risk
20
serious Num Affected
19
serious Num At Risk
20
title
Arm A (Daunorubicin and Cytarabine Liposome, Pomalidomide)
deaths Num Affected
7
deaths Num At Risk
19
description
INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. Patients who do not respond, may receive a second cycle of liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients who achieve CR/CRi receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression and unacceptable toxicity. Patients also undergo bone marrow aspirate and biopsy and collection of blood samples throughout all phases of the trial. Biospecimen Collection: Undergo collection of blood samples Bone Marrow Aspiration and Biopsy: Undergo bone marrow aspirate and biopsy Liposome-encapsulated Daunorubicin-Cytarabine: Given IV
id
EG003
other Num Affected
18
other Num At Risk
19
serious Num Affected
19
serious Num At Risk
19
title
Arm B (Daunorubicin and Cytarabine Liposome)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
17
group Id
EG001
num Affected
2
num At Risk
3
num Events
10
group Id
EG002
num Affected
8
num At Risk
20
num Events
24
group Id
EG003
num Affected
8
num At Risk
19
num Events
27
term
Alanine Aminotransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
6
num At Risk
7
num Events
25
group Id
EG001
num Affected
2
num At Risk
3
num Events
16
group Id
EG002
num Affected
8
num At Risk
20
num Events
34
group Id
EG003
num Affected
8
num At Risk
19
num Events
36
term
Aspartate Aminotransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
1
num At Risk
3
num Events
2
group Id
EG002
num Affected
6
num At Risk
20
num Events
12
group Id
EG003
num Affected
1
num At Risk
19
num Events
1
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
20
num Events
2
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Activated Partial Thromboplastin Time Prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Acute Kidney Injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
4
num At Risk
7
num Events
10
group Id
EG001
num Affected
2
num At Risk
3
num Events
15
group Id
EG002
num Affected
7
num At Risk
20
num Events
18
group Id
EG003
num Affected
4
num At Risk
19
num Events
9
term
Alkaline Phosphatase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Alkalosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Allergic Reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
2
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Anal Fissure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
1
num At Risk
19
num Events
2
term
Anal Fistula

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
3
group Id
EG001
num Affected
1
num At Risk
3
num Events
3
group Id
EG002
num Affected
2
num At Risk
20
num Events
3
group Id
EG003
num Affected
1
num At Risk
19
num Events
2
term
Alanine Aminotransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Acute Respiratory Distress Syndrome (ARDS)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
2
num At Risk
7
num Events
4
group Id
EG001
num Affected
1
num At Risk
3
num Events
3
group Id
EG002
num Affected
2
num At Risk
20
num Events
10
group Id
EG003
num Affected
3
num At Risk
19
num Events
3
term
Aspartate Aminotransferase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Activated Partial Thromboplastin Time Prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
2
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Acute Kidney Injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
2
num At Risk
20
num Events
2
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Alkaline Phosphatase Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
7
num At Risk
7
num Events
60
group Id
EG001
num Affected
3
num At Risk
3
num Events
21
group Id
EG002
num Affected
13
num At Risk
20
num Events
76
group Id
EG003
num Affected
11
num At Risk
19
num Events
49
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
1
num At Risk
7
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
20
num Events
0
group Id
EG003
num Affected
1
num At Risk
19
num Events
6
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
2
num At Risk
20
num Events
2
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE v.5.0
stats
group Id
EG000
num Affected
0
num At Risk
7
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
1
num At Risk
20
num Events
1
group Id
EG003
num Affected
0
num At Risk
19
num Events
0
term
Atrial Flutter

time Frame

Up to 30 days after last dose, up to 2 years

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

Preserved source evidence · Not medical advice