NCT02924376 · ADVERSE EVENTS

Adverse events

Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202) · Source last updated 2025-08-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: up to 1584 days
Other-event reporting threshold: 5%

Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort A: FGFR2 Rearrangements or Fusions Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	46 / 108	108 / 108	76 / 108
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	10 / 20	20 / 20	18 / 20
Cohort C: Negative for FGF/FGFR Alterations Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.	12 / 17	17 / 17	15 / 17
Other Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.	0 / 2	2 / 2	2 / 2
Total Total	68 / 147	147 / 147	111 / 147

Group identifiers: EG000: Cohort A: FGFR2 Rearrangements or Fusions · EG001: Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions · EG002: Cohort C: Negative for FGF/FGFR Alterations · EG003: Other · EG004: Total

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 24
stats
group Id
EG000
num Affected
4
num At Risk
108
num Events
6
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
2
num At Risk
17
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
7
num At Risk
147
num Events
9
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
1
num At Risk
108
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
2
num At Risk
108
num Events
2
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
3
num At Risk
147
num Events
3
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
1
num At Risk
108
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
147
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
108
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
1
term
Anaphylactic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
1
num At Risk
108
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
1
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
1
num At Risk
108
num Events
2
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
147
num Events
3
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
108
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
2
num At Risk
17
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
147
num Events
2
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
2
num At Risk
108
num Events
2
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
147
num Events
2
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
2
num At Risk
108
num Events
2
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
147
num Events
2
term
Biliary obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
1
num At Risk
108
num Events
2
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
2
term
Biliary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
108
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
1
term
Biloma

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 24
stats
group Id
EG000
num Affected
9
num At Risk
108
num Events
10
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
10
num At Risk
147
num Events
11
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
22
num At Risk
108
num Events
39
group Id
EG001
num Affected
3
num At Risk
20
num Events
3
group Id
EG002
num Affected
3
num At Risk
17
num Events
3
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
29
num At Risk
147
num Events
46
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
11
num At Risk
108
num Events
16
group Id
EG001
num Affected
2
num At Risk
20
num Events
2
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
14
num At Risk
147
num Events
19
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
108
num Events
0
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
1
term
Accidental overdose
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
108
num Events
0
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
1
term
Acinetobacter bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
3
num At Risk
108
num Events
3
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
4
num At Risk
147
num Events
4
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
5
num At Risk
108
num Events
6
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
2
num At Risk
17
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
8
num At Risk
147
num Events
9
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
12
num At Risk
108
num Events
16
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
13
num At Risk
147
num Events
17
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
64
num At Risk
108
num Events
66
group Id
EG001
num Affected
4
num At Risk
20
num Events
4
group Id
EG002
num Affected
3
num At Risk
17
num Events
3
group Id
EG003
num Affected
2
num At Risk
2
num Events
2
group Id
EG004
num Affected
73
num At Risk
147
num Events
75
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
16
num At Risk
108
num Events
27
group Id
EG001
num Affected
2
num At Risk
20
num Events
2
group Id
EG002
num Affected
2
num At Risk
17
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
20
num At Risk
147
num Events
31
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
37
num At Risk
108
num Events
52
group Id
EG001
num Affected
5
num At Risk
20
num Events
8
group Id
EG002
num Affected
2
num At Risk
17
num Events
3
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
44
num At Risk
147
num Events
63
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
4
num At Risk
108
num Events
4
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
5
num At Risk
147
num Events
5
term
Ascites

Complete source fields

description

event Groups

deaths Num Affected
76
deaths Num At Risk
108
description
Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
id
EG000
other Num Affected
108
other Num At Risk
108
serious Num Affected
46
serious Num At Risk
108
title
Cohort A: FGFR2 Rearrangements or Fusions
deaths Num Affected
18
deaths Num At Risk
20
description
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
id
EG001
other Num Affected
20
other Num At Risk
20
serious Num Affected
10
serious Num At Risk
20
title
Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
deaths Num Affected
15
deaths Num At Risk
17
description
Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
id
EG002
other Num Affected
17
other Num At Risk
17
serious Num Affected
12
serious Num At Risk
17
title
Cohort C: Negative for FGF/FGFR Alterations
deaths Num Affected
2
deaths Num At Risk
2
description
Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
id
EG003
other Num Affected
2
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Other
deaths Num Affected
111
deaths Num At Risk
147
description
Total
id
EG004
other Num Affected
147
other Num At Risk
147
serious Num Affected
68
serious Num At Risk
147
title
Total

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
9
num At Risk
108
num Events
10
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
10
num At Risk
147
num Events
11
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
22
num At Risk
108
num Events
39
group Id
EG001
num Affected
3
num At Risk
20
num Events
3
group Id
EG002
num Affected
3
num At Risk
17
num Events
3
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
29
num At Risk
147
num Events
46
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
11
num At Risk
108
num Events
16
group Id
EG001
num Affected
2
num At Risk
20
num Events
2
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
14
num At Risk
147
num Events
19
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
108
num Events
0
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
1
term
Accidental overdose
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
108
num Events
0
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
1
term
Acinetobacter bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
3
num At Risk
108
num Events
3
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
1
num At Risk
2
num Events
1
group Id
EG004
num Affected
4
num At Risk
147
num Events
4
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
5
num At Risk
108
num Events
6
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
2
num At Risk
17
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
8
num At Risk
147
num Events
9
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
12
num At Risk
108
num Events
16
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
13
num At Risk
147
num Events
17
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
64
num At Risk
108
num Events
66
group Id
EG001
num Affected
4
num At Risk
20
num Events
4
group Id
EG002
num Affected
3
num At Risk
17
num Events
3
group Id
EG003
num Affected
2
num At Risk
2
num Events
2
group Id
EG004
num Affected
73
num At Risk
147
num Events
75
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
16
num At Risk
108
num Events
27
group Id
EG001
num Affected
2
num At Risk
20
num Events
2
group Id
EG002
num Affected
2
num At Risk
17
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
20
num At Risk
147
num Events
31
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
37
num At Risk
108
num Events
52
group Id
EG001
num Affected
5
num At Risk
20
num Events
8
group Id
EG002
num Affected
2
num At Risk
17
num Events
3
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
44
num At Risk
147
num Events
63
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
4
num At Risk
108
num Events
4
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
5
num At Risk
147
num Events
5
term
Ascites

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
4
num At Risk
108
num Events
6
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
2
num At Risk
17
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
7
num At Risk
147
num Events
9
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
1
num At Risk
108
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
2
num At Risk
108
num Events
2
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
3
num At Risk
147
num Events
3
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
1
num At Risk
108
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
147
num Events
2
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
108
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
1
term
Anaphylactic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
1
num At Risk
108
num Events
1
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
1
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
1
num At Risk
108
num Events
2
group Id
EG001
num Affected
1
num At Risk
20
num Events
1
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
147
num Events
3
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
108
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
2
num At Risk
17
num Events
2
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
147
num Events
2
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
2
num At Risk
108
num Events
2
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
147
num Events
2
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
2
num At Risk
108
num Events
2
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
2
num At Risk
147
num Events
2
term
Biliary obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
1
num At Risk
108
num Events
2
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
0
num At Risk
17
num Events
0
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
2
term
Biliary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
108
num Events
0
group Id
EG001
num Affected
0
num At Risk
20
num Events
0
group Id
EG002
num Affected
1
num At Risk
17
num Events
1
group Id
EG003
num Affected
0
num At Risk
2
num Events
0
group Id
EG004
num Affected
1
num At Risk
147
num Events
1
term
Biloma

time Frame

up to 1584 days

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

Preserved source evidence · Not medical advice