NCT01653028 · ADVERSE EVENTS

Adverse events

Alisertib in Treating Patients With Advanced or Metastatic Sarcoma · Source last updated 2017-11-30

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1 Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	2 / 12	12 / 12	Not reported / Not reported
Cohort 2 Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	2 / 10	8 / 10	Not reported / Not reported
Cohort 3 Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	1 / 11	11 / 11	Not reported / Not reported
Cohort4 Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	4 / 10	9 / 10	Not reported / Not reported
Cohort 5 Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	13 / 29	28 / 29	Not reported / Not reported

Group identifiers: EG000: Cohort 1 · EG001: Cohort 2 · EG002: Cohort 3 · EG003: Cohort4 · EG004: Cohort 5

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 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
2
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
1
num At Risk
11
num Events
2
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
2
num At Risk
29
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Colonic fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
3
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Duodenal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
3
group Id
EG001
num Affected
2
num At Risk
10
num Events
2
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
2
num At Risk
29
num Events
3
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Typhlitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
4
num At Risk
29
num Events
5
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
2
num At Risk
29
num Events
2
term
Lung infection

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 10
stats
group Id
EG000
num Affected
10
num At Risk
12
num Events
32
group Id
EG001
num Affected
4
num At Risk
10
num Events
15
group Id
EG002
num Affected
7
num At Risk
11
num Events
44
group Id
EG003
num Affected
6
num At Risk
10
num Events
15
group Id
EG004
num Affected
15
num At Risk
29
num Events
37
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
2
num At Risk
29
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
2
num At Risk
29
num Events
4
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
3
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
4
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Eye pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Watering eyes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
10
num Events
3
group Id
EG002
num Affected
1
num At Risk
11
num Events
2
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Anal mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
2
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Colonic hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
10
num Events
4
group Id
EG002
num Affected
1
num At Risk
11
num Events
2
group Id
EG003
num Affected
3
num At Risk
10
num Events
3
group Id
EG004
num Affected
3
num At Risk
29
num Events
12
term
Constipation

Complete source fields

event Groups

description
Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
12
other Num At Risk
12
serious Num Affected
2
serious Num At Risk
12
title
Cohort 1
description
Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
8
other Num At Risk
10
serious Num Affected
2
serious Num At Risk
10
title
Cohort 2
description
Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
EG002
other Num Affected
11
other Num At Risk
11
serious Num Affected
1
serious Num At Risk
11
title
Cohort 3
description
Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
EG003
other Num Affected
9
other Num At Risk
10
serious Num Affected
4
serious Num At Risk
10
title
Cohort4
description
Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
EG004
other Num Affected
28
other Num At Risk
29
serious Num Affected
13
serious Num At Risk
29
title
Cohort 5

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
10
num At Risk
12
num Events
32
group Id
EG001
num Affected
4
num At Risk
10
num Events
15
group Id
EG002
num Affected
7
num At Risk
11
num Events
44
group Id
EG003
num Affected
6
num At Risk
10
num Events
15
group Id
EG004
num Affected
15
num At Risk
29
num Events
37
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
2
num At Risk
29
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
2
num At Risk
29
num Events
4
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
3
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
4
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Eye pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Watering eyes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
10
num Events
3
group Id
EG002
num Affected
1
num At Risk
11
num Events
2
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
2
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Anal mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
2
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Colonic hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
10
num Events
4
group Id
EG002
num Affected
1
num At Risk
11
num Events
2
group Id
EG003
num Affected
3
num At Risk
10
num Events
3
group Id
EG004
num Affected
3
num At Risk
29
num Events
12
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
2
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
1
num At Risk
11
num Events
2
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
2
num At Risk
29
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Colonic fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
3
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Duodenal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
12
num Events
3
group Id
EG001
num Affected
2
num At Risk
10
num Events
2
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Mucositis oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
2
num At Risk
29
num Events
3
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
12
num Events
1
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
0
num At Risk
29
num Events
0
term
Typhlitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
1
num At Risk
10
num Events
1
group Id
EG004
num Affected
4
num At Risk
29
num Events
5
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
1
num At Risk
10
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
1
num At Risk
29
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
0
num At Risk
12
num Events
0
group Id
EG001
num Affected
0
num At Risk
10
num Events
0
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
group Id
EG003
num Affected
0
num At Risk
10
num Events
0
group Id
EG004
num Affected
2
num At Risk
29
num Events
2
term
Lung infection

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

Preserved source evidence · Not medical advice