NCT02393248 · ADVERSE EVENTS

Adverse events

Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101) · Source last updated 2023-01-06

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: up to 869 days
Other-event reporting threshold: 5%

Treatment-emergent adverse events (TEAEs), 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, are reported for all enrolled participants who received at least 1 dose of study drug (Safety Population).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Part 1: Intermittent Pemigatinib 1/2/4 mg QD Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.	1 / 3	3 / 3	3 / 3
Part 1: Intermittent Pemigatinib 6 mg QD Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.	0 / 4	3 / 4	2 / 4
Parts 1 and 2: Intermittent Pemigatinib 9 mg QD Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.	3 / 7	7 / 7	6 / 7
Parts 1 and 2: Intermittent Pemigatinib 13.5 mg QD Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.	21 / 50	50 / 50	37 / 50
Part 1: Intermittent Pemigatinib 20 mg QD Participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.	3 / 6	6 / 6	6 / 6
Parts 1 and 2: Continuous Pemigatinib 9 mg QD Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.	6 / 14	14 / 14	10 / 14
Parts 1 and 2: Continuous Pemigatinib 13.5 mg QD Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.	14 / 30	30 / 30	21 / 30
Parts 1 and 2: Continuous Pemigatinib 20 mg QD Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.	7 / 15	15 / 15	10 / 15
Part 1: Continuous Pemigatinib 7.5 mg BID Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.	2 / 4	4 / 4	4 / 4
Part 1: Continuous Pemigatinib 10 mg BID Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.	2 / 3	3 / 3	2 / 3
Part 3: Gem/Cis/Intermittent Pemigatinib 9 mg Participants received gemcitabine (Gem) intravenously starting at 1000 mg/meters squared (m\^2) on Days 1 and 8 of each 21-day cycle. Cisplatin (Cis) was administered intravenously starting at 70 mg/m\^2 once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.	1 / 1	1 / 1	1 / 1
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg Participants received gemcitabine intravenously starting at 1000 mg/m\^2 on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m\^2 once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.	3 / 7	7 / 7	7 / 7
Part 3: Tras/Intermittent Pemigatinib 13.5 mg Trastuzumab (Tras) was administered as an open-label, commercial product at an initial intravenous dose of 8 mg/kilograms (kg), followed by 6 mg/kg intravenously once every 3 weeks. The dose could have been adjusted for toxicity management, per commercial labeling. The investigator could have interrupted, modified, or discontinued trastuzumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of trastuzumab.	0 / 6	6 / 6	5 / 6
Part 3: Doc/Intermittent Pemigatinib 13.5 mg Participants received docetaxel (Doc) intravenously starting at 75 mg/m\^2 once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of docetaxel.	6 / 7	7 / 7	5 / 7
Part 3: Pem/Intermittent Pemigatinib 9 mg Participants received pembrolizumab (Pem) intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.	1 / 3	3 / 3	3 / 3
Part 3: Pem/Intermittent Pemigatinib 13.5 mg Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.	7 / 14	14 / 14	9 / 14
Part 3: Pem/Continuous Pemigatinib 13.5 mg Participants received pembrolizumab intravenously at 200 mg once every 3 weeks on Day 1 of each cycle. The dose could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued pembrolizumab with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle. It was permissible to continue pemigatinib administration during the toxicity break of pembrolizumab.	3 / 9	9 / 9	6 / 9
Part 3: Ref/Continuous Pemigatinib 9 mg Retifanlimab (Ref) was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial intravenous dose of 500 mg. Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.	4 / 7	7 / 7	6 / 7
Part 3: Ref/Continuous Pemigatinib 13.5 mg Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial intravenous dose of 500 mg. Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle	5 / 9	9 / 9	3 / 9
Part 3: Ref/Continuous Pemigatinib 20 mg Retifanlimab was administered once every 4 weeks on a 28-day cycle as an open-label product, at an initial intravenous dose of 500 mg. Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.	2 / 2	2 / 2	0 / 2

Group identifiers: EG000: Part 1: Intermittent Pemigatinib 1/2/4 mg QD · EG001: Part 1: Intermittent Pemigatinib 6 mg QD · EG002: Parts 1 and 2: Intermittent Pemigatinib 9 mg QD · EG003: Parts 1 and 2: Intermittent Pemigatinib 13.5 mg QD · EG004: Part 1: Intermittent Pemigatinib 20 mg QD · EG005: Parts 1 and 2: Continuous Pemigatinib 9 mg QD · EG006: Parts 1 and 2: Continuous Pemigatinib 13.5 mg QD · EG007: Parts 1 and 2: Continuous Pemigatinib 20 mg QD · EG008: Part 1: Continuous Pemigatinib 7.5 mg BID · EG009: Part 1: Continuous Pemigatinib 10 mg BID · EG010: Part 3: Gem/Cis/Intermittent Pemigatinib 9 mg · EG011: Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg · EG012: Part 3: Tras/Intermittent Pemigatinib 13.5 mg · EG013: Part 3: Doc/Intermittent Pemigatinib 13.5 mg · EG014: Part 3: Pem/Intermittent Pemigatinib 9 mg · EG015: Part 3: Pem/Intermittent Pemigatinib 13.5 mg · EG016: Part 3: Pem/Continuous Pemigatinib 13.5 mg · EG017: Part 3: Ref/Continuous Pemigatinib 9 mg · EG018: Part 3: Ref/Continuous Pemigatinib 13.5 mg · EG019: Part 3: Ref/Continuous Pemigatinib 20 mg

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
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
2
num At Risk
50
num Events
2
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
1
num At Risk
15
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
3
num At Risk
30
num Events
4
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
1
num At Risk
7
num Events
2
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Acute respiratory failure
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
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Alcohol poisoning
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
1
num At Risk
15
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
1
num At Risk
15
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Atrial thrombosis
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
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
2
num At Risk
30
num Events
2
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
1
num At Risk
30
num Events
1
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Blood alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Blood bilirubin increased

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
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
1
num At Risk
7
num Events
1
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
4
num At Risk
50
num Events
4
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
2
num At Risk
30
num Events
2
group Id
EG007
num Affected
3
num At Risk
15
num Events
3
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
group Id
EG003
num Affected
10
num At Risk
50
num Events
10
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
2
num At Risk
14
num Events
2
group Id
EG006
num Affected
6
num At Risk
30
num Events
6
group Id
EG007
num Affected
2
num At Risk
15
num Events
2
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
1
num At Risk
1
num Events
1
group Id
EG011
num Affected
1
num At Risk
7
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
1
num At Risk
7
num Events
1
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
2
num At Risk
14
num Events
2
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
1
num At Risk
15
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
1
num At Risk
7
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
1
num At Risk
7
num Events
1
term
Abdominal tenderness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Actinic keratosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
2
num At Risk
30
num Events
3
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
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
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
3
num At Risk
30
num Events
3
group Id
EG007
num Affected
1
num At Risk
15
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
1
num At Risk
7
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Acute sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
1
num At Risk
15
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Adjustment disorder with depressed mood
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Adrenal insufficiency

Complete source fields

description

event Groups

deaths Num Affected
3
deaths Num At Risk
3
description
Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
id
EG000
other Num Affected
3
other Num At Risk
3
serious Num Affected
1
serious Num At Risk
3
title
Part 1: Intermittent Pemigatinib 1/2/4 mg QD
deaths Num Affected
2
deaths Num At Risk
4
description
Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
id
EG001
other Num Affected
3
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Part 1: Intermittent Pemigatinib 6 mg QD
deaths Num Affected
6
deaths Num At Risk
7
description
Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
id
EG002
other Num Affected
7
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Parts 1 and 2: Intermittent Pemigatinib 9 mg QD
deaths Num Affected
37
deaths Num At Risk
50
description
Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in either Part 1 or Part 2. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
id
EG003
other Num Affected
50
other Num At Risk
50
serious Num Affected
21
serious Num At Risk
50
title
Parts 1 and 2: Intermittent Pemigatinib 13.5 mg QD
deaths Num Affected
6
deaths Num At Risk
6
description
Participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule in Part 1. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
id
EG004
other Num Affected
6
other Num At Risk
6
serious Num Affected
3
serious Num At Risk
6
title
Part 1: Intermittent Pemigatinib 20 mg QD
deaths Num Affected
10
deaths Num At Risk
14
description
Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.
id
EG005
other Num Affected
14
other Num At Risk
14
serious Num Affected
6
serious Num At Risk
14
title
Parts 1 and 2: Continuous Pemigatinib 9 mg QD
deaths Num Affected
21
deaths Num At Risk
30
description
Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.
id
EG006
other Num Affected
30
other Num At Risk
30
serious Num Affected
14
serious Num At Risk
30
title
Parts 1 and 2: Continuous Pemigatinib 13.5 mg QD
deaths Num Affected
10
deaths Num At Risk
15
description
Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle in either Part 1 or Part 2.
id
EG007
other Num Affected
15
other Num At Risk
15
serious Num Affected
7
serious Num At Risk
15
title
Parts 1 and 2: Continuous Pemigatinib 20 mg QD
deaths Num Affected
4
deaths Num At Risk
4
description
Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.
id
EG008
other Num Affected
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
title
Part 1: Continuous Pemigatinib 7.5 mg BID
deaths Num Affected
2
deaths Num At Risk
3
description
Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.
id
EG009
other Num Affected
3
other Num At Risk
3
serious Num Affected
2
serious Num At Risk
3
title
Part 1: Continuous Pemigatinib 10 mg BID
deaths Num Affected
1
deaths Num At Risk
1
description
Participants received gemcitabine (Gem) intravenously starting at 1000 mg/meters squared (m\^2) on Days 1 and 8 of each 21-day cycle. Cisplatin (Cis) was administered intravenously starting at 70 mg/m\^2 once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.
id
EG010
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Part 3: Gem/Cis/Intermittent Pemigatinib 9 mg
deaths Num Affected
7
deaths Num At Risk
7
description
Participants received gemcitabine intravenously starting at 1000 mg/m\^2 on Days 1 and 8 of each 21-day cycle. Cisplatin was administered intravenously starting at 70 mg/m\^2 once every 3 weeks on Day 1 of each 21-day cycle. Both gemcitabine and cisplatin doses could have been adjusted for toxicity management per commercial labeling. The investigator could have interrupted, modified, or discontinued chemotherapy with medical monitor approval. Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break. It was permissible to continue pemigatinib administration during the toxicity break of gemcitabine/cisplatin.
id
EG011
other Num Affected
7
other Num At Risk
7
serious Num Affected
3
serious Num At Risk
7
title
Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
1
num At Risk
7
num Events
1
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
4
num At Risk
50
num Events
4
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
2
num At Risk
30
num Events
2
group Id
EG007
num Affected
3
num At Risk
15
num Events
3
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
1
num At Risk
7
num Events
1
group Id
EG003
num Affected
10
num At Risk
50
num Events
10
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
2
num At Risk
14
num Events
2
group Id
EG006
num Affected
6
num At Risk
30
num Events
6
group Id
EG007
num Affected
2
num At Risk
15
num Events
2
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
1
num At Risk
1
num Events
1
group Id
EG011
num Affected
1
num At Risk
7
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
1
num At Risk
7
num Events
1
term
Abdominal pain lower
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
2
num At Risk
14
num Events
2
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
1
num At Risk
15
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
1
num At Risk
7
num Events
1
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
1
num At Risk
7
num Events
1
term
Abdominal tenderness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Actinic keratosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
2
num At Risk
30
num Events
3
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
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
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
3
num At Risk
30
num Events
3
group Id
EG007
num Affected
1
num At Risk
15
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
1
num At Risk
7
num Events
1
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
1
num At Risk
6
num Events
1
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Acute sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
1
num At Risk
15
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Adjustment disorder with depressed mood
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Adrenal insufficiency

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
2
num At Risk
50
num Events
2
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
1
num At Risk
15
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
3
num At Risk
30
num Events
4
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
1
num At Risk
7
num Events
2
term
Acute kidney injury
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Acute respiratory failure
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
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Alcohol poisoning
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
1
num At Risk
15
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Atrial flutter
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
0
num At Risk
50
num Events
0
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
1
num At Risk
15
num Events
1
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Atrial thrombosis
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
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
1
num At Risk
14
num Events
1
group Id
EG006
num Affected
2
num At Risk
30
num Events
2
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
1
num At Risk
30
num Events
1
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Blood alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 24
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
4
num Events
0
group Id
EG002
num Affected
0
num At Risk
7
num Events
0
group Id
EG003
num Affected
1
num At Risk
50
num Events
1
group Id
EG004
num Affected
0
num At Risk
6
num Events
0
group Id
EG005
num Affected
0
num At Risk
14
num Events
0
group Id
EG006
num Affected
0
num At Risk
30
num Events
0
group Id
EG007
num Affected
0
num At Risk
15
num Events
0
group Id
EG008
num Affected
0
num At Risk
4
num Events
0
group Id
EG009
num Affected
0
num At Risk
3
num Events
0
group Id
EG010
num Affected
0
num At Risk
1
num Events
0
group Id
EG011
num Affected
0
num At Risk
7
num Events
0
term
Blood bilirubin increased

time Frame

up to 869 days

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

Preserved source evidence · Not medical advice