TriangleNCT01905657 · OUTCOME
Percentage of Participants Experiencing Adverse Events (AEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
What was measured
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Analysis population: Per protocol, participants experiencing AEs for the first pembrolizumab course and docetaxel treatment arms were analyzed in the All Participants As Treated (APAT) population. This consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.
Groups in this outcome
Pembrolizumab 2 mg/kg
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
Pembrolizumab 10 mg/kg
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
Docetaxel 75 mg/m^2
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
| Group | Source count |
|---|---|
| Pembrolizumab 2 mg/kg | 339 |
| Pembrolizumab 10 mg/kg | 343 |
| Docetaxel 75 mg/m^2 | 309 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 2 mg/kg | 97.6 | Not reported | Not reported | Not reported | Not reported |
| Pembrolizumab 10 mg/kg | 96.2 | Not reported | Not reported | Not reported | Not reported |
| Docetaxel 75 mg/m^2 | 96.1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 97.6
- group Id
- OG001
- value
- 96.2
- group Id
- OG002
- value
- 96.1
- denoms
- counts
- group Id
- OG000
- value
- 339
- group Id
- OG001
- value
- 343
- group Id
- OG002
- value
- 309
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
- groups
- description
- Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
- id
- OG000
- title
- Pembrolizumab 2 mg/kg
- description
- Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
- id
- OG001
- title
- Pembrolizumab 10 mg/kg
- description
- Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
- id
- OG002
- title
- Docetaxel 75 mg/m^2
- param Type
- NUMBER
- population Description
- Per protocol, participants experiencing AEs for the first pembrolizumab course and docetaxel treatment arms were analyzed in the All Participants As Treated (APAT) population. This consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.
- reporting Status
- POSTED
- time Frame
- Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
- title
- Percentage of Participants Experiencing Adverse Events (AEs)
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice