TriangleNCT03783078 · OUTCOME
Duration of Response (DOR)
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
For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.
Analysis population: The analysis population consisted of all allocated participants who received at least 1 dose of study treatment, and who experienced a confirmed CR or confirmed PR.
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 | 27 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab 200 mg | 39.8 | Not reported | 23.8 | NA | NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse. |
Complete source fields
- classes
- categories
- measurements
- comment
- NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
- group Id
- OG000
- lower Limit
- 23.8
- upper Limit
- NA
- value
- 39.8
- denoms
- counts
- group Id
- OG000
- value
- 27
- units
- Participants
- description
- For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR 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, and who experienced a confirmed CR or confirmed PR.
- reporting Status
- POSTED
- time Frame
- Up to ~58 months
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice