NCT02400476 · ADVERSE EVENTS

Adverse events

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide · Source last updated 2022-05-06

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: From time of first dose, through 28 days after last dose, assessed up to 15.5 months.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Loperamide 240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed. Neratinib Loperamide	9 / 137	137 / 137	0 / 137
Budesonide and Loperamide 240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter. Neratinib Loperamide Budesonide: 9 mg extended release tablets once daily with or without food for 28 days	4 / 64	64 / 64	0 / 64
Colestipol and Loperamide 240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle	9 / 136	136 / 136	0 / 136
Colestipol With Loperamide as Needed 240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle	3 / 104	104 / 104	0 / 104
Neratinib Dose Escalation 1 120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed. Neratinib Loperamide	5 / 60	60 / 60	0 / 60
Neratinib Dose Escalation 2 160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only. Neratinib Loperamide	5 / 62	62 / 62	0 / 62

Group identifiers: EG000: Loperamide · EG001: Budesonide and Loperamide · EG002: Colestipol and Loperamide · EG003: Colestipol With Loperamide as Needed · EG004: Neratinib Dose Escalation 1 · EG005: Neratinib Dose Escalation 2

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
Eye disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
1
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Retinal detachment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
2
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
1
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
1
num At Risk
62
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
1
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
1
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Fat necrosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
1
num At Risk
62
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
1
num At Risk
62
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Cholecystitis acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Cholelithiasis

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 (24.0)
stats
group Id
EG000
num Affected
8
num At Risk
137
group Id
EG001
num Affected
5
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
136
group Id
EG003
num Affected
5
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
4
num At Risk
64
group Id
EG002
num Affected
3
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
1
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
7
num At Risk
137
group Id
EG001
num Affected
2
num At Risk
64
group Id
EG002
num Affected
7
num At Risk
136
group Id
EG003
num Affected
5
num At Risk
104
group Id
EG004
num Affected
2
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
21
num At Risk
137
group Id
EG001
num Affected
5
num At Risk
64
group Id
EG002
num Affected
22
num At Risk
136
group Id
EG003
num Affected
15
num At Risk
104
group Id
EG004
num Affected
6
num At Risk
60
group Id
EG005
num Affected
10
num At Risk
62
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
36
num At Risk
137
group Id
EG001
num Affected
12
num At Risk
64
group Id
EG002
num Affected
26
num At Risk
136
group Id
EG003
num Affected
27
num At Risk
104
group Id
EG004
num Affected
13
num At Risk
60
group Id
EG005
num Affected
15
num At Risk
62
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
5
num At Risk
137
group Id
EG001
num Affected
7
num At Risk
64
group Id
EG002
num Affected
16
num At Risk
136
group Id
EG003
num Affected
7
num At Risk
104
group Id
EG004
num Affected
3
num At Risk
60
group Id
EG005
num Affected
8
num At Risk
62
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
78
num At Risk
137
group Id
EG001
num Affected
48
num At Risk
64
group Id
EG002
num Affected
93
num At Risk
136
group Id
EG003
num Affected
39
num At Risk
104
group Id
EG004
num Affected
22
num At Risk
60
group Id
EG005
num Affected
15
num At Risk
62
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
109
num At Risk
137
group Id
EG001
num Affected
55
num At Risk
64
group Id
EG002
num Affected
113
num At Risk
136
group Id
EG003
num Affected
99
num At Risk
104
group Id
EG004
num Affected
59
num At Risk
60
group Id
EG005
num Affected
61
num At Risk
62
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
18
num At Risk
137
group Id
EG001
num Affected
6
num At Risk
64
group Id
EG002
num Affected
12
num At Risk
136
group Id
EG003
num Affected
5
num At Risk
104
group Id
EG004
num Affected
4
num At Risk
60
group Id
EG005
num Affected
3
num At Risk
62
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
12
num At Risk
137
group Id
EG001
num Affected
10
num At Risk
64
group Id
EG002
num Affected
16
num At Risk
136
group Id
EG003
num Affected
13
num At Risk
104
group Id
EG004
num Affected
7
num At Risk
60
group Id
EG005
num Affected
6
num At Risk
62
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
5
num At Risk
137
group Id
EG001
num Affected
6
num At Risk
64
group Id
EG002
num Affected
5
num At Risk
136
group Id
EG003
num Affected
2
num At Risk
104
group Id
EG004
num Affected
1
num At Risk
60
group Id
EG005
num Affected
3
num At Risk
62
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
10
num At Risk
137
group Id
EG001
num Affected
5
num At Risk
64
group Id
EG002
num Affected
10
num At Risk
136
group Id
EG003
num Affected
6
num At Risk
104
group Id
EG004
num Affected
2
num At Risk
60
group Id
EG005
num Affected
4
num At Risk
62
term
Gastrooesophageal reflux disease

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
137
description
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed. Neratinib Loperamide
id
EG000
other Num Affected
137
other Num At Risk
137
serious Num Affected
9
serious Num At Risk
137
title
Loperamide
deaths Num Affected
0
deaths Num At Risk
64
description
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter. Neratinib Loperamide Budesonide: 9 mg extended release tablets once daily with or without food for 28 days
id
EG001
other Num Affected
64
other Num At Risk
64
serious Num Affected
4
serious Num At Risk
64
title
Budesonide and Loperamide
deaths Num Affected
0
deaths Num At Risk
136
description
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle
id
EG002
other Num Affected
136
other Num At Risk
136
serious Num Affected
9
serious Num At Risk
136
title
Colestipol and Loperamide
deaths Num Affected
0
deaths Num At Risk
104
description
240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle
id
EG003
other Num Affected
104
other Num At Risk
104
serious Num Affected
3
serious Num At Risk
104
title
Colestipol With Loperamide as Needed
deaths Num Affected
0
deaths Num At Risk
60
description
120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed. Neratinib Loperamide
id
EG004
other Num Affected
60
other Num At Risk
60
serious Num Affected
5
serious Num At Risk
60
title
Neratinib Dose Escalation 1
deaths Num Affected
0
deaths Num At Risk
62
description
160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only. Neratinib Loperamide
id
EG005
other Num Affected
62
other Num At Risk
62
serious Num Affected
5
serious Num At Risk
62
title
Neratinib Dose Escalation 2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
8
num At Risk
137
group Id
EG001
num Affected
5
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
136
group Id
EG003
num Affected
5
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
4
num At Risk
64
group Id
EG002
num Affected
3
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
1
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
7
num At Risk
137
group Id
EG001
num Affected
2
num At Risk
64
group Id
EG002
num Affected
7
num At Risk
136
group Id
EG003
num Affected
5
num At Risk
104
group Id
EG004
num Affected
2
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
21
num At Risk
137
group Id
EG001
num Affected
5
num At Risk
64
group Id
EG002
num Affected
22
num At Risk
136
group Id
EG003
num Affected
15
num At Risk
104
group Id
EG004
num Affected
6
num At Risk
60
group Id
EG005
num Affected
10
num At Risk
62
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
36
num At Risk
137
group Id
EG001
num Affected
12
num At Risk
64
group Id
EG002
num Affected
26
num At Risk
136
group Id
EG003
num Affected
27
num At Risk
104
group Id
EG004
num Affected
13
num At Risk
60
group Id
EG005
num Affected
15
num At Risk
62
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
5
num At Risk
137
group Id
EG001
num Affected
7
num At Risk
64
group Id
EG002
num Affected
16
num At Risk
136
group Id
EG003
num Affected
7
num At Risk
104
group Id
EG004
num Affected
3
num At Risk
60
group Id
EG005
num Affected
8
num At Risk
62
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
78
num At Risk
137
group Id
EG001
num Affected
48
num At Risk
64
group Id
EG002
num Affected
93
num At Risk
136
group Id
EG003
num Affected
39
num At Risk
104
group Id
EG004
num Affected
22
num At Risk
60
group Id
EG005
num Affected
15
num At Risk
62
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
109
num At Risk
137
group Id
EG001
num Affected
55
num At Risk
64
group Id
EG002
num Affected
113
num At Risk
136
group Id
EG003
num Affected
99
num At Risk
104
group Id
EG004
num Affected
59
num At Risk
60
group Id
EG005
num Affected
61
num At Risk
62
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
18
num At Risk
137
group Id
EG001
num Affected
6
num At Risk
64
group Id
EG002
num Affected
12
num At Risk
136
group Id
EG003
num Affected
5
num At Risk
104
group Id
EG004
num Affected
4
num At Risk
60
group Id
EG005
num Affected
3
num At Risk
62
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
12
num At Risk
137
group Id
EG001
num Affected
10
num At Risk
64
group Id
EG002
num Affected
16
num At Risk
136
group Id
EG003
num Affected
13
num At Risk
104
group Id
EG004
num Affected
7
num At Risk
60
group Id
EG005
num Affected
6
num At Risk
62
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
5
num At Risk
137
group Id
EG001
num Affected
6
num At Risk
64
group Id
EG002
num Affected
5
num At Risk
136
group Id
EG003
num Affected
2
num At Risk
104
group Id
EG004
num Affected
1
num At Risk
60
group Id
EG005
num Affected
3
num At Risk
62
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
10
num At Risk
137
group Id
EG001
num Affected
5
num At Risk
64
group Id
EG002
num Affected
10
num At Risk
136
group Id
EG003
num Affected
6
num At Risk
104
group Id
EG004
num Affected
2
num At Risk
60
group Id
EG005
num Affected
4
num At Risk
62
term
Gastrooesophageal reflux disease

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
1
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Retinal detachment
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
2
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
1
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
1
num At Risk
62
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
1
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
1
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Fat necrosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
1
num At Risk
62
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
1
num At Risk
62
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
0
num At Risk
64
group Id
EG002
num Affected
1
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Cholecystitis acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (24.0)
stats
group Id
EG000
num Affected
0
num At Risk
137
group Id
EG001
num Affected
1
num At Risk
64
group Id
EG002
num Affected
0
num At Risk
136
group Id
EG003
num Affected
0
num At Risk
104
group Id
EG004
num Affected
0
num At Risk
60
group Id
EG005
num Affected
0
num At Risk
62
term
Cholelithiasis

time Frame

From time of first dose, through 28 days after last dose, assessed up to 15.5 months.

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

Preserved source evidence · Not medical advice