NCT02428192 · ADVERSE EVENTS

Adverse events

Nivolumab Alone or in Combination With Ipilimumab in Treating Patients With Advanced Uterine Leiomyosarcoma · Source last updated 2025-02-25

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 4 cyles
Other-event reporting threshold: 5%

Maximum grade toxicity by type was first calculated. Serious AEs were defined as events grade 3 or higher per CTCAEv4. Other AEs were defined as anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 5%. These are grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015) Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV	4 / 12	12 / 12	0 / 12
Cohort B (Nivolumab and Ipilimumab) Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies	3 / 8	8 / 8	0 / 8

Group identifiers: EG000: Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015) · EG001: Cohort B (Nivolumab and Ipilimumab)

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
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Serum amylase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Lipase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
2
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Small Intestinal Obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Hematuria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Major Depression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Renal Colic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Surgical Procedures (debulking/palliative surgery)

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
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
8
term
Akathisia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
12
group Id
EG001
num Affected
2
num At Risk
8
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
3
num At Risk
8
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
8
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
12
group Id
EG001
num Affected
3
num At Risk
8
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
8
term
Dysgeusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
8
term
Edema Limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
8
term
Erythema Nodosum
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
8
num At Risk
12
group Id
EG001
num Affected
2
num At Risk
8
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
8
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
8
term
Flu like Symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
8
term
Flushing

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
12
description
Patients receive nivolumab IV over approximately 60 minutes once every 2 weeks for up to 46 doses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
id
EG000
other Num Affected
12
other Num At Risk
12
serious Num Affected
4
serious Num At Risk
12
title
Cohort A (Nivolumab - Closed to Accrual on 21-Oct-2015)
deaths Num Affected
0
deaths Num At Risk
8
description
Patients receive nivolumab IV over approximately 60 minutes followed by a saline flush and ipilimumab IV over 90 minutes. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Ipilimumab: Given IV Laboratory Biomarker Analysis: Correlative studies
id
EG001
other Num Affected
8
other Num At Risk
8
serious Num Affected
3
serious Num At Risk
8
title
Cohort B (Nivolumab and Ipilimumab)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
8
term
Akathisia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
12
group Id
EG001
num Affected
2
num At Risk
8
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
3
num At Risk
8
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
8
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
12
group Id
EG001
num Affected
3
num At Risk
8
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
8
term
Dysgeusia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
8
term
Edema Limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
8
term
Erythema Nodosum
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
8
num At Risk
12
group Id
EG001
num Affected
2
num At Risk
8
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
8
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
8
term
Flu like Symptoms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
8
term
Flushing

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Serum amylase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Lipase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
White blood cell decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
2
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Small Intestinal Obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Hematuria
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Major Depression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Renal Colic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Surgical Procedures (debulking/palliative surgery)

time Frame

Up to 4 cyles

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

Preserved source evidence · Not medical advice