NCT02500797 · ADVERSE EVENTS

Adverse events

Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery · Source last updated 2023-10-17

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 weeks after completion of study treatment; up to 44 months
Other-event reporting threshold: 0%

Serious AEs and Other (Not Including Serious) AEs summary tables summarizes AEs assessed for participants who started treatment and were evaluable for AEs. All-cause mortality is assessed for all enrolled participants. Adverse events are described and graded using the terminology and grading categories defined in the NCI's Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0. However, CTCAE v5.0 is used for serious AE reporting through CTEP-AERS as of April 1, 2018.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Initial Single Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.	19 / 42	39 / 42	37 / 43
Initial Dual Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.	21 / 42	40 / 42	34 / 42
LPS Single Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.	9 / 15	15 / 15	11 / 15
LPS Dual Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.	1 / 14	14 / 14	10 / 14
UPS/MFH Single Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.	8 / 13	12 / 13	10 / 14
UPS/MFH Dual Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.	7 / 14	14 / 14	7 / 15
GIST Single Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.	5 / 10	10 / 10	8 / 10
GIST Dual Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.	6 / 11	10 / 11	7 / 11

Group identifiers: EG000: Initial Single · EG001: Initial Dual · EG002: LPS Single · EG003: LPS Dual · EG004: UPS/MFH Single · EG005: UPS/MFH Dual · EG006: GIST Single · EG007: GIST Dual

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
4
num At Risk
42
num Events
5
group Id
EG001
num Affected
5
num At Risk
42
num Events
5
group Id
EG002
num Affected
2
num At Risk
15
num Events
2
group Id
EG003
num Affected
1
num At Risk
14
num Events
1
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
3
num At Risk
42
num Events
3
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Papilledema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
4
group Id
EG001
num Affected
2
num At Risk
42
num Events
2
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
1
num At Risk
14
num Events
1
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
11
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
11
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Colonic perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
3
num At Risk
11
num Events
3
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Jejunal obstruction

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
10
num At Risk
42
num Events
13
group Id
EG001
num Affected
10
num At Risk
42
num Events
16
group Id
EG002
num Affected
3
num At Risk
15
num Events
5
group Id
EG003
num Affected
3
num At Risk
14
num Events
6
group Id
EG004
num Affected
2
num At Risk
13
num Events
3
group Id
EG005
num Affected
3
num At Risk
14
num Events
7
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
1
num At Risk
11
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
42
num Events
1
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
42
num Events
13
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
2
num At Risk
42
num Events
5
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
2
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Paroxysmal atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
42
num Events
1
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
2
group Id
EG003
num Affected
1
num At Risk
14
num Events
1
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
1
num At Risk
14
num Events
1
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Ear and labyrinth disorders - Oth spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
External ear inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
3
num At Risk
42
num Events
7
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
42
num Events
3
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
8
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Endocrine disorders - Other, specify

Complete source fields

description

event Groups

deaths Num Affected
37
deaths Num At Risk
43
description
Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
39
other Num At Risk
42
serious Num Affected
19
serious Num At Risk
42
title
Initial Single
deaths Num Affected
34
deaths Num At Risk
42
description
Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
40
other Num At Risk
42
serious Num Affected
21
serious Num At Risk
42
title
Initial Dual
deaths Num Affected
11
deaths Num At Risk
15
description
Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
id
EG002
other Num Affected
15
other Num At Risk
15
serious Num Affected
9
serious Num At Risk
15
title
LPS Single
deaths Num Affected
10
deaths Num At Risk
14
description
Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
id
EG003
other Num Affected
14
other Num At Risk
14
serious Num Affected
1
serious Num At Risk
14
title
LPS Dual
deaths Num Affected
10
deaths Num At Risk
14
description
Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
id
EG004
other Num Affected
12
other Num At Risk
13
serious Num Affected
8
serious Num At Risk
13
title
UPS/MFH Single
deaths Num Affected
7
deaths Num At Risk
15
description
Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
id
EG005
other Num Affected
14
other Num At Risk
14
serious Num Affected
7
serious Num At Risk
14
title
UPS/MFH Dual
deaths Num Affected
8
deaths Num At Risk
10
description
Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
id
EG006
other Num Affected
10
other Num At Risk
10
serious Num Affected
5
serious Num At Risk
10
title
GIST Single
deaths Num Affected
7
deaths Num At Risk
11
description
Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
id
EG007
other Num Affected
10
other Num At Risk
11
serious Num Affected
6
serious Num At Risk
11
title
GIST Dual

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
10
num At Risk
42
num Events
13
group Id
EG001
num Affected
10
num At Risk
42
num Events
16
group Id
EG002
num Affected
3
num At Risk
15
num Events
5
group Id
EG003
num Affected
3
num At Risk
14
num Events
6
group Id
EG004
num Affected
2
num At Risk
13
num Events
3
group Id
EG005
num Affected
3
num At Risk
14
num Events
7
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
1
num At Risk
11
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
42
num Events
1
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
42
num Events
13
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
2
num At Risk
42
num Events
5
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Cardiac disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
2
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Paroxysmal atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
42
num Events
1
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
1
num At Risk
15
num Events
2
group Id
EG003
num Affected
1
num At Risk
14
num Events
1
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
1
num At Risk
14
num Events
1
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Ear and labyrinth disorders - Oth spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
External ear inflammation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
3
num At Risk
42
num Events
7
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
1
num At Risk
42
num Events
3
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
8
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Endocrine disorders - Other, specify

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
4
num At Risk
42
num Events
5
group Id
EG001
num Affected
5
num At Risk
42
num Events
5
group Id
EG002
num Affected
2
num At Risk
15
num Events
2
group Id
EG003
num Affected
1
num At Risk
14
num Events
1
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
1
num At Risk
10
num Events
1
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
3
num At Risk
42
num Events
3
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Adrenal insufficiency
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Papilledema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
3
num At Risk
42
num Events
4
group Id
EG001
num Affected
2
num At Risk
42
num Events
2
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
1
num At Risk
14
num Events
1
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
11
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
42
num Events
0
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
1
num At Risk
11
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Colonic perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
1
num At Risk
13
num Events
1
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
3
num At Risk
11
num Events
3
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
42
num Events
1
group Id
EG001
num Affected
0
num At Risk
42
num Events
0
group Id
EG002
num Affected
0
num At Risk
15
num Events
0
group Id
EG003
num Affected
0
num At Risk
14
num Events
0
group Id
EG004
num Affected
0
num At Risk
13
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
10
num Events
0
group Id
EG007
num Affected
0
num At Risk
11
num Events
0
term
Jejunal obstruction

time Frame

Up to 4 weeks after completion of study treatment; up to 44 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice