TriangleNCT02393248 · OUTCOME
Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- up to 763 days
What was measured
Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were 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.
Analysis population: Safety Population: all enrolled participants who received at least 1 dose of study drug
Groups in this outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
| Group | Source count |
|---|---|
| Part 1: Intermittent Pemigatinib 1/2/4 mg QD | 3 |
| Part 1: Intermittent Pemigatinib 6 mg QD | 4 |
| Parts 1 and 2: Intermittent Pemigatinib 9 mg QD | 7 |
| Parts 1 and 2: Intermittent Pemigatinib 13.5 mg QD | 50 |
| Part 1: Intermittent Pemigatinib 20 mg QD | 6 |
| Parts 1 and 2: Continuous Pemigatinib 9 mg QD | 14 |
| Parts 1 and 2: Continuous Pemigatinib 13.5 mg QD | 30 |
| Parts 1 and 2: Continuous Pemigatinib 20 mg QD | 15 |
| Part 1: Continuous Pemigatinib 7.5 mg BID | 4 |
| Part 1: Continuous Pemigatinib 10 mg BID | 3 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Intermittent Pemigatinib 1/2/4 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Intermittent Pemigatinib 6 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Parts 1 and 2: Intermittent Pemigatinib 9 mg QD | 7 | Not reported | Not reported | Not reported | Not reported |
| Parts 1 and 2: Intermittent Pemigatinib 13.5 mg QD | 50 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Intermittent Pemigatinib 20 mg QD | 6 | Not reported | Not reported | Not reported | Not reported |
| Parts 1 and 2: Continuous Pemigatinib 9 mg QD | 14 | Not reported | Not reported | Not reported | Not reported |
| Parts 1 and 2: Continuous Pemigatinib 13.5 mg QD | 30 | Not reported | Not reported | Not reported | Not reported |
| Parts 1 and 2: Continuous Pemigatinib 20 mg QD | 15 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Continuous Pemigatinib 7.5 mg BID | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Continuous Pemigatinib 10 mg BID | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 50
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 30
- group Id
- OG007
- value
- 15
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 50
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 30
- group Id
- OG007
- value
- 15
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 3
- units
- Participants
- description
- Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occurred after a participant provided informed consent. Abnormal laboratory values or test results that occurred after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were 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.
- groups
- 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
- OG000
- title
- Part 1: Intermittent Pemigatinib 1/2/4 mg QD
- 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
- OG001
- title
- Part 1: Intermittent Pemigatinib 6 mg QD
- 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
- OG002
- title
- Parts 1 and 2: Intermittent Pemigatinib 9 mg QD
- 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
- OG003
- title
- Parts 1 and 2: Intermittent Pemigatinib 13.5 mg QD
- 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
- OG004
- title
- Part 1: Intermittent Pemigatinib 20 mg QD
- 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
- OG005
- title
- Parts 1 and 2: Continuous Pemigatinib 9 mg QD
- 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
- OG006
- title
- Parts 1 and 2: Continuous Pemigatinib 13.5 mg QD
- 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
- OG007
- title
- Parts 1 and 2: Continuous Pemigatinib 20 mg QD
- description
- Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.
- id
- OG008
- title
- Part 1: Continuous Pemigatinib 7.5 mg BID
- description
- Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.
- id
- OG009
- title
- Part 1: Continuous Pemigatinib 10 mg BID
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population: all enrolled participants who received at least 1 dose of study drug
- reporting Status
- POSTED
- time Frame
- up to 763 days
- title
- Parts 1 and 2 Combined: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice