TriangleNCT03783078 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to ~58 months
What was measured
Progression-Free Survival was defined as the time from the first dose of study treatment to the first documented evidence of disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented.
Analysis population: The analysis population consisted of all allocated participants who received at least 1 dose of study treatment.
Groups in this outcome
Pembrolizumab 200 mg
Adult participants received pembrolizumab (MK-3475) 200 mg or pediatric participants received 2 mg/kg (up to 200 mg) on Day 1 Q3W IV for up to 35 administrations (approximately 2 years).
| Group | Source count |
|---|---|
| Pembrolizumab 200 mg | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 200 mg | 9.3 | Not reported | 3.0 | 25.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.0
- upper Limit
- 25.5
- value
- 9.3
- denoms
- counts
- group Id
- OG000
- value
- 55
- units
- Participants
- description
- Progression-Free Survival was defined as the time from the first dose of study treatment to the first documented evidence of disease progression per RECIST 1.1 by BICR or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Adult participants received pembrolizumab (MK-3475) 200 mg or pediatric participants received 2 mg/kg (up to 200 mg) on Day 1 Q3W IV for up to 35 administrations (approximately 2 years).
- id
- OG000
- title
- Pembrolizumab 200 mg
- param Type
- MEDIAN
- population Description
- The analysis population consisted of all allocated participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to ~58 months
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice