TriangleNCT02460198 · OUTCOME
Number of Participants Who Experienced an Adverse Event (AE).
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 66 months
What was measured
An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Analysis population: The analysis population consisted of all participants who received at least one dose of study treatment.
Groups in this outcome
Cohort A - Pembrolizumab 200 mg
Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
Cohort B - Pembrolizumab 200 mg
Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
| Group | Source count |
|---|---|
| Cohort A - Pembrolizumab 200 mg | 61 |
| Cohort B - Pembrolizumab 200 mg | 63 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort A - Pembrolizumab 200 mg | 60 | Not reported | Not reported | Not reported | Not reported |
| Cohort B - Pembrolizumab 200 mg | 63 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 63
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 63
- units
- Participants
- description
- An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
- groups
- description
- Participants were previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Cohort A participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to approximately 35 cycles (up to approximately 2 years).
- id
- OG000
- title
- Cohort A - Pembrolizumab 200 mg
- description
- Participants were previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody. Cohort B participants received pembrolizumab 200 mg IV on Day 1 Q3W for up to approximately 35 cycles (up to approximately 2 years).
- id
- OG001
- title
- Cohort B - Pembrolizumab 200 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The analysis population consisted of all participants who received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to approximately 66 months
- title
- Number of Participants Who Experienced an Adverse Event (AE).
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice