NCT02508532 · ADVERSE EVENTS

Adverse events

(NAVIGATOR) Study of BLU-285 in Patients With Gastrointestinal Stromal Tumors (GIST) and Other Relapsed and Refractory Solid Tumors · Source last updated 2022-06-21

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: For each patient adverse event data were collected starting at the time of the first dose of study drug until 30 days after the final dose of study drug. Serious adverse event data were collected from the time the informed consent was signed until 30 days after the final dose of study drug. On average 8 months, up to 5 years.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.	3 / 6	6 / 6	0 / 6
Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.	4 / 6	6 / 6	4 / 6
Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.	5 / 6	5 / 6	2 / 6
Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.	5 / 6	6 / 6	4 / 6
Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.	5 / 6	6 / 6	3 / 6
Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.	3 / 3	3 / 3	1 / 3
Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 or 400 mg QD Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis. Patients received avapritinib in continuous 28 day cycles until discontinuation.	140 / 217	214 / 217	111 / 217

Group identifiers: EG000: Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD · EG001: Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD · EG002: Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD · EG003: Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD · EG004: Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD · EG005: Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD · EG006: Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 or 400 mg QD

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
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
24
num At Risk
217
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
217
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
8
num At Risk
217
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
4
num At Risk
217
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
217
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
4
num At Risk
217
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
217
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
217
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
217
term
Melaena
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
2
num At Risk
217
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
217
term
Peritoneal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
217
term
Small intestinal haemorrhage

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
MedRA
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
24
num At Risk
217
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
16
num At Risk
217
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
14
num At Risk
217
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
4
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
4
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
95
num At Risk
217
term
Periorbital oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
6
group Id
EG003
num Affected
4
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
76
num At Risk
217
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
18
num At Risk
217
term
Eyelid oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
14
num At Risk
217
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
54
num At Risk
217
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
4
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
36
num At Risk
217
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
22
num At Risk
217
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
22
num At Risk
217
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
18
num At Risk
217
term
Abdominal pain upper

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
6
description
Part 1: Patients received a starting dose of 30 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
id
EG000
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Experimental: Part 1 Avapritinib (Formerly BLU-285) 30 mg QD
deaths Num Affected
4
deaths Num At Risk
6
description
Part 1: Patients received a starting dose of 60 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
id
EG001
other Num Affected
6
other Num At Risk
6
serious Num Affected
4
serious Num At Risk
6
title
Experimental: Part 1 Avapritinib (Formerly BLU-285) 60 mg QD
deaths Num Affected
2
deaths Num At Risk
6
description
Part 1: Patients received a starting dose of 90 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
id
EG002
other Num Affected
5
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
Experimental: Part 1 Avapritinib (Formerly BLU-285) 90 mg QD
deaths Num Affected
4
deaths Num At Risk
6
description
Part 1: Patients received a starting dose of 135 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
id
EG003
other Num Affected
6
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
Experimental: Part 1 Avapritinib (Formerly BLU-285) 135 mg QD
deaths Num Affected
3
deaths Num At Risk
6
description
Part 1: Patients received a starting dose of 200 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
id
EG004
other Num Affected
6
other Num At Risk
6
serious Num Affected
5
serious Num At Risk
6
title
Experimental: Part 1 Avapritinib (Formerly BLU-285) 200 mg QD
deaths Num Affected
1
deaths Num At Risk
3
description
Part 1: Patients received a starting dose of 600 mg QD for 28 days and they were assessed for dose limiting toxicities (DLT). If no DTLs were observed the dose escalation continued. Patients received avapritinib in continuous 28 day cycles until discontinuation.
id
EG005
other Num Affected
3
other Num At Risk
3
serious Num Affected
3
serious Num At Risk
3
title
Experimental: Part 1 Avapritinib (Formerly BLU-285) 600 mg QD
deaths Num Affected
111
deaths Num At Risk
217
description
Part 1 and Part 2: Patients enrolled in Part 1 and Part 2 at a starting dose of 300 or 400 mg QD were included in the Part1/Part 2 safety and efficacy analysis. Patients received avapritinib in continuous 28 day cycles until discontinuation.
id
EG006
other Num Affected
214
other Num At Risk
217
serious Num Affected
140
serious Num At Risk
217
title
Experimental: Part 1 and Part 2 Avapritinib (Formerly BLU-285) 300 or 400 mg QD

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
24
num At Risk
217
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
16
num At Risk
217
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
14
num At Risk
217
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
4
num At Risk
6
group Id
EG001
num Affected
4
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
4
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
95
num At Risk
217
term
Periorbital oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
6
group Id
EG003
num Affected
4
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
76
num At Risk
217
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
1
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
18
num At Risk
217
term
Eyelid oedema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
14
num At Risk
217
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
3
num At Risk
6
group Id
EG002
num Affected
2
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
2
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
54
num At Risk
217
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
2
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
4
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
36
num At Risk
217
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
2
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
22
num At Risk
217
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
22
num At Risk
217
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
2
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
18
num At Risk
217
term
Abdominal pain upper

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
1
num At Risk
3
group Id
EG006
num Affected
24
num At Risk
217
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
1
num At Risk
217
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
8
num At Risk
217
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
1
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
4
num At Risk
217
term
Upper gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
1
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
217
term
Gastrointestinal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
4
num At Risk
217
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
1
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
217
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
217
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
217
term
Melaena
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
1
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
2
num At Risk
217
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
217
term
Peritoneal haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedRA
stats
group Id
EG000
num Affected
0
num At Risk
6
group Id
EG001
num Affected
0
num At Risk
6
group Id
EG002
num Affected
0
num At Risk
6
group Id
EG003
num Affected
0
num At Risk
6
group Id
EG004
num Affected
0
num At Risk
6
group Id
EG005
num Affected
0
num At Risk
3
group Id
EG006
num Affected
3
num At Risk
217
term
Small intestinal haemorrhage

time Frame

For each patient adverse event data were collected starting at the time of the first dose of study drug until 30 days after the final dose of study drug. Serious adverse event data were collected from the time the informed consent was signed until 30 days after the final dose of study drug. On average 8 months, up to 5 years.

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

Preserved source evidence · Not medical advice