NCT03261947 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors · Source last updated 2021-09-20

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: All-Cause Mortality: Up to approximately 43 months; Serious and Other Adverse Events: From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)
Other-event reporting threshold: 5%

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. A total of 67 deaths occurred in this study. Since all the information for death data could not be collected, not all deaths could be reported in all-cause mortality.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Western Safety Cohort TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.	7 / 12	5 / 12	10 / 12
Pancreatic Cancer Cohort TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	6 / 15	8 / 15	13 / 15
Metastatic CRC Cohort TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.	8 / 35	27 / 35	17 / 35
sqEC Cohort TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.	5 / 21	14 / 21	12 / 21
sqNSCLC Cohort TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.	3 / 18	14 / 18	8 / 18

Group identifiers: EG000: Western Safety Cohort · EG001: Pancreatic Cancer Cohort · EG002: Metastatic CRC Cohort · EG003: sqEC Cohort · EG004: sqNSCLC Cohort

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
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
2
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
1
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
2
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
2
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
1
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Duodenal ulcer perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
1
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Large intestine perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Malignant pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Cancer pain

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
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
12
group Id
EG001
num Affected
5
num At Risk
15
group Id
EG002
num Affected
16
num At Risk
35
group Id
EG003
num Affected
7
num At Risk
21
group Id
EG004
num Affected
7
num At Risk
18
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
3
num At Risk
15
group Id
EG002
num Affected
14
num At Risk
35
group Id
EG003
num Affected
2
num At Risk
21
group Id
EG004
num Affected
7
num At Risk
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
2
num At Risk
15
group Id
EG002
num Affected
6
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
4
num At Risk
18
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
6
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
2
num At Risk
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
5
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
2
num At Risk
18
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
4
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
1
num At Risk
18
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
2
num At Risk
18
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
2
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Proctalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Faeces discoloured

Complete source fields

description

event Groups

deaths Num Affected
10
deaths Num At Risk
12
description
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
id
EG000
other Num Affected
5
other Num At Risk
12
serious Num Affected
7
serious Num At Risk
12
title
Western Safety Cohort
deaths Num Affected
13
deaths Num At Risk
15
description
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
id
EG001
other Num Affected
8
other Num At Risk
15
serious Num Affected
6
serious Num At Risk
15
title
Pancreatic Cancer Cohort
deaths Num Affected
17
deaths Num At Risk
35
description
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
id
EG002
other Num Affected
27
other Num At Risk
35
serious Num Affected
8
serious Num At Risk
35
title
Metastatic CRC Cohort
deaths Num Affected
12
deaths Num At Risk
21
description
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
id
EG003
other Num Affected
14
other Num At Risk
21
serious Num Affected
5
serious Num At Risk
21
title
sqEC Cohort
deaths Num Affected
8
deaths Num At Risk
18
description
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
id
EG004
other Num Affected
14
other Num At Risk
18
serious Num Affected
3
serious Num At Risk
18
title
sqNSCLC Cohort

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
12
group Id
EG001
num Affected
5
num At Risk
15
group Id
EG002
num Affected
16
num At Risk
35
group Id
EG003
num Affected
7
num At Risk
21
group Id
EG004
num Affected
7
num At Risk
18
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
3
num At Risk
15
group Id
EG002
num Affected
14
num At Risk
35
group Id
EG003
num Affected
2
num At Risk
21
group Id
EG004
num Affected
7
num At Risk
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
2
num At Risk
15
group Id
EG002
num Affected
6
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
4
num At Risk
18
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
3
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
6
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
2
num At Risk
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
5
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
2
num At Risk
18
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
4
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
1
num At Risk
18
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
2
num At Risk
18
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
2
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Proctalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Faeces discoloured

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
2
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
1
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
2
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
2
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
1
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Duodenal ulcer perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
1
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Large intestine perforation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
2
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Malignant pleural effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 23.0
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
15
group Id
EG002
num Affected
0
num At Risk
35
group Id
EG003
num Affected
0
num At Risk
21
group Id
EG004
num Affected
0
num At Risk
18
term
Cancer pain

time Frame

All-Cause Mortality: Up to approximately 43 months; Serious and Other Adverse Events: From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)

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

Preserved source evidence · Not medical advice