NCT02397720 · ADVERSE EVENTS

Adverse events

Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia · Source last updated 2025-06-08

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 7 years, 6 months
Other-event reporting threshold: 5%

There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm 1 A Lead-In (Azacitidine, Nivolumab) Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	6 / 6	6 / 6	1 / 6
Arm 1 B (Azacitidine, Nivolumab) Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	57 / 85	62 / 85	16 / 85
Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	2 / 6	5 / 6	1 / 6
Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	33 / 47	25 / 47	5 / 47
Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV	5 / 6	4 / 6	1 / 6
Arm 3 B (Azacitidine, Nivolumab, Venetoclax) Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV	0 / 0	0 / 0	0 / 0

Group identifiers: EG000: Arm 1 A Lead-In (Azacitidine, Nivolumab) · EG001: Arm 1 B (Azacitidine, Nivolumab) · EG002: Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) · EG003: Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) · EG004: Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) · EG005: Arm 3 B (Azacitidine, Nivolumab, Venetoclax)

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
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Catheter related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
2
group Id
EG001
num Affected
25
num At Risk
85
num Events
36
group Id
EG002
num Affected
2
num At Risk
6
num Events
5
group Id
EG003
num Affected
15
num At Risk
47
num Events
22
group Id
EG004
num Affected
3
num At Risk
6
num Events
3
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
General disorders and administration site conditions
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
1
num At Risk
85
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
4
group Id
EG001
num Affected
32
num At Risk
85
num Events
45
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
15
num At Risk
47
num Events
25
group Id
EG004
num Affected
2
num At Risk
6
num Events
3
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Lumbar Spine Stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
2
num At Risk
47
num Events
4
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
4
num At Risk
47
num Events
4
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
2
num At Risk
85
num Events
2
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
85
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
85
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Arthritis

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
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
85
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
4
num At Risk
47
num Events
4
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Abdominal Distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
3
num At Risk
85
num Events
4
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
5
num At Risk
47
num Events
7
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
2
num At Risk
47
num Events
3
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
47
num Events
1
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
3
group Id
EG001
num Affected
2
num At Risk
85
num Events
2
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
3
num At Risk
47
num Events
3
group Id
EG004
num Affected
2
num At Risk
6
num Events
2
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
2
num At Risk
47
num Events
2
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
85
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
4
num At Risk
47
num Events
4
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
1
num At Risk
85
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
2
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Benign Prostatic Hyperplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Myelosuppression

Complete source fields

description

There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.

event Groups

deaths Num Affected
1
deaths Num At Risk
6
description
Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
6
serious Num At Risk
6
title
Arm 1 A Lead-In (Azacitidine, Nivolumab)
deaths Num Affected
16
deaths Num At Risk
85
description
Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV
id
EG001
other Num Affected
62
other Num At Risk
85
serious Num Affected
57
serious Num At Risk
85
title
Arm 1 B (Azacitidine, Nivolumab)
deaths Num Affected
1
deaths Num At Risk
6
description
Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV
id
EG002
other Num Affected
5
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab)
deaths Num Affected
5
deaths Num At Risk
47
description
Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV
id
EG003
other Num Affected
25
other Num At Risk
47
serious Num Affected
33
serious Num At Risk
47
title
Arm 2 B (Azacitidine, Nivolumab, Ipilimumab)
deaths Num Affected
1
deaths Num At Risk
6
description
Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
id
EG004
other Num Affected
4
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax)
deaths Num Affected
0
deaths Num At Risk
0
description
Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
id
EG005
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Arm 3 B (Azacitidine, Nivolumab, Venetoclax)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
85
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
4
num At Risk
47
num Events
4
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Abdominal Distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Acidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
3
num At Risk
85
num Events
4
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
5
num At Risk
47
num Events
7
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
2
num At Risk
47
num Events
3
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
1
num At Risk
47
num Events
1
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
3
group Id
EG001
num Affected
2
num At Risk
85
num Events
2
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
3
num At Risk
47
num Events
3
group Id
EG004
num Affected
2
num At Risk
6
num Events
2
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
2
num At Risk
47
num Events
2
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Anxiety
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
85
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
4
num At Risk
47
num Events
4
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
1
num At Risk
85
num Events
1
group Id
EG002
num Affected
1
num At Risk
6
num Events
2
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Benign Prostatic Hyperplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Myelosuppression

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Catheter related infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
2
group Id
EG001
num Affected
25
num At Risk
85
num Events
36
group Id
EG002
num Affected
2
num At Risk
6
num Events
5
group Id
EG003
num Affected
15
num At Risk
47
num Events
22
group Id
EG004
num Affected
3
num At Risk
6
num Events
3
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
General disorders and administration site conditions
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
1
num At Risk
85
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
4
group Id
EG001
num Affected
32
num At Risk
85
num Events
45
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
15
num At Risk
47
num Events
25
group Id
EG004
num Affected
2
num At Risk
6
num Events
3
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Lung infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Lumbar Spine Stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
2
num At Risk
47
num Events
4
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Pneumonitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
6
num Events
2
group Id
EG001
num Affected
0
num At Risk
85
num Events
0
group Id
EG002
num Affected
1
num At Risk
6
num Events
1
group Id
EG003
num Affected
4
num At Risk
47
num Events
4
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
2
num At Risk
85
num Events
2
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
85
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
6
num Events
0
group Id
EG001
num Affected
1
num At Risk
85
num Events
1
group Id
EG002
num Affected
0
num At Risk
6
num Events
0
group Id
EG003
num Affected
0
num At Risk
47
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
0
num Events
0
term
Arthritis

time Frame

Up to 7 years, 6 months

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

Preserved source evidence · Not medical advice