TriangleNCT02393248 · OUTCOME
Part 3: Number of Participants With Any 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 869 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
Groups in this outcome
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
| Group | Source count |
|---|---|
| Part 3: Gem/Cis/Intermittent Pemigatinib 9 mg | 1 |
| Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg | 7 |
| Part 3: Tras/Intermittent Pemigatinib 13.5 mg | 6 |
| Part 3: Doc/Intermittent Pemigatinib 13.5 mg | 7 |
| Part 3: Pem/Intermittent Pemigatinib 9 mg | 3 |
| Part 3: Pem/Intermittent Pemigatinib 13.5 mg | 14 |
| Part 3: Pem/Continuous Pemigatinib 13.5 mg | 9 |
| Part 3: Ref/Continuous Pemigatinib 9 mg | 7 |
| Part 3: Ref/Continuous Pemigatinib 13.5 mg | 9 |
| Part 3: Ref/Continuous Pemigatinib 20 mg | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 3: Gem/Cis/Intermittent Pemigatinib 9 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 3: Tras/Intermittent Pemigatinib 13.5 mg | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 3: Doc/Intermittent Pemigatinib 13.5 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 3: Pem/Intermittent Pemigatinib 9 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 3: Pem/Intermittent Pemigatinib 13.5 mg | 14 | Not reported | Not reported | Not reported | Not reported |
| Part 3: Pem/Continuous Pemigatinib 13.5 mg | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 3: Ref/Continuous Pemigatinib 9 mg | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 3: Ref/Continuous Pemigatinib 13.5 mg | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 3: Ref/Continuous Pemigatinib 20 mg | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 9
- group Id
- OG009
- value
- 2
- 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 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
- OG000
- title
- Part 3: Gem/Cis/Intermittent Pemigatinib 9 mg
- 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
- OG001
- title
- Part 3: Gem/Cis/Intermittent Pemigatinib 13.5 mg
- description
- 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.
- id
- OG002
- title
- Part 3: Tras/Intermittent Pemigatinib 13.5 mg
- description
- 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.
- id
- OG003
- title
- Part 3: Doc/Intermittent Pemigatinib 13.5 mg
- description
- 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.
- id
- OG004
- title
- Part 3: Pem/Intermittent Pemigatinib 9 mg
- description
- 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.
- id
- OG005
- title
- Part 3: Pem/Intermittent Pemigatinib 13.5 mg
- description
- 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.
- id
- OG006
- title
- Part 3: Pem/Continuous Pemigatinib 13.5 mg
- description
- 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.
- id
- OG007
- title
- Part 3: Ref/Continuous Pemigatinib 9 mg
- description
- 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
- id
- OG008
- title
- Part 3: Ref/Continuous Pemigatinib 13.5 mg
- description
- 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.
- id
- OG009
- title
- Part 3: Ref/Continuous Pemigatinib 20 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population
- reporting Status
- POSTED
- time Frame
- up to 869 days
- title
- Part 3: Number of Participants With Any TEAE
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice