TriangleNCT01704287 · OUTCOME
Number of Participants Who Experienced an Adverse Event (AE) - Overall Study
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 approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
What was measured
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study drug, was also an AE. Participants were included in the treatment group in which an AE was experienced. The number of participants who experienced at least one AE is presented.
Analysis population: The analysis population consisted of all participants who received at least one dose of study drug.
Groups in this outcome
Pembrolizumab 2 mg/kg
Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
Pembrolizumab 10 mg/kg
Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
ICC Only
Participants were randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
ICC→Pembrolizumab 2 mg/kg
Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)
ICC→Pembrolizumab 10 mg/kg
Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)
ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab)
Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)
ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab)
Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)
| Group | Source count |
|---|---|
| Pembrolizumab 2 mg/kg | 178 |
| Pembrolizumab 10 mg/kg | 179 |
| ICC Only | 73 |
| ICC→Pembrolizumab 2 mg/kg | 53 |
| ICC→Pembrolizumab 10 mg/kg | 45 |
| ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab) | 53 |
| ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab) | 45 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | 172 | Not reported | Not reported | Not reported | Not reported |
| Pembrolizumab 10 mg/kg | 179 | Not reported | Not reported | Not reported | Not reported |
| ICC Only | 71 | Not reported | Not reported | Not reported | Not reported |
| ICC→Pembrolizumab 2 mg/kg | 52 | Not reported | Not reported | Not reported | Not reported |
| ICC→Pembrolizumab 10 mg/kg | 45 | Not reported | Not reported | Not reported | Not reported |
| ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab) | 53 | Not reported | Not reported | Not reported | Not reported |
| ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab) | 41 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 179
- group Id
- OG002
- value
- 71
- group Id
- OG003
- value
- 52
- group Id
- OG004
- value
- 45
- group Id
- OG005
- value
- 53
- group Id
- OG006
- value
- 41
- denoms
- counts
- group Id
- OG000
- value
- 178
- group Id
- OG001
- value
- 179
- group Id
- OG002
- value
- 73
- group Id
- OG003
- value
- 53
- group Id
- OG004
- value
- 45
- group Id
- OG005
- value
- 53
- group Id
- OG006
- value
- 45
- units
- Participants
- description
- An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study drug, was also an AE. Participants were included in the treatment group in which an AE was experienced. The number of participants who experienced at least one AE is presented.
- groups
- description
- Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
- id
- OG000
- title
- Pembrolizumab 2 mg/kg
- description
- Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
- id
- OG001
- title
- Pembrolizumab 10 mg/kg
- description
- Participants were randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
- id
- OG002
- title
- ICC Only
- description
- Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)
- id
- OG003
- title
- ICC→Pembrolizumab 2 mg/kg
- description
- Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)
- id
- OG004
- title
- ICC→Pembrolizumab 10 mg/kg
- description
- Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)
- id
- OG005
- title
- ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab)
- description
- Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)
- id
- OG006
- title
- ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The analysis population consisted of all participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
- title
- Number of Participants Who Experienced an Adverse Event (AE) - Overall Study
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice