TriangleNCT03553836 · OUTCOME
Number of Participants Who Experienced at Least One 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 ~19.3 months
What was measured
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, analysis for this outcome measure was performed using the initial pembrolizumab or placebo treatment.
Analysis population: All randomized participants who received at least one dose of study treatment.
Groups in this outcome
Pembrolizumab
Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1.
Placebo
Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1.
| Group | Source count |
|---|---|
| Pembrolizumab | 483 |
| Placebo | 486 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab | 461 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 444 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.3
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Difference in percentage based on Miettinen \& Nurminen method.
- non Inferiority Type
- OTHER
- param Type
- Difference in Percentage
- param Value
- 4.1
Complete source fields
- analyses
- ci Lower Limit
- 1.0
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.3
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Difference in percentage based on Miettinen \& Nurminen method.
- non Inferiority Type
- OTHER
- param Type
- Difference in Percentage
- param Value
- 4.1
- classes
- categories
- measurements
- group Id
- OG000
- value
- 461
- group Id
- OG001
- value
- 444
- denoms
- counts
- group Id
- OG000
- value
- 483
- group Id
- OG001
- value
- 486
- units
- Participants
- description
- An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, analysis for this outcome measure was performed using the initial pembrolizumab or placebo treatment.
- groups
- description
- Participants received 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1.
- id
- OG000
- title
- Pembrolizumab
- description
- Participants received saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to \~1 year) in Part 1.
- id
- OG001
- title
- Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All randomized participants who received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to ~19.3 months
- title
- Number of Participants Who Experienced at Least One Adverse Event (AE)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice