NCT02721732 · OUTCOME
Progression-free Survival (PFS) Using RECIST v1.1
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
- Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks, an average of 4 years.
What was measured
PFS was defined as the time from administration of the first dose to the first documented disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Patients who were alive and had not experienced disease progression at the time of data cutoff were censored.
Analysis population: All patients who have received at least 1 dose of study medication with at least one adequate on-study tumor assessment were included in the efficacy analysis. If a patient discontinued the study before the first radiological assessment due to progression of disease, either radiological or clinical, they were considered evaluable and were included in the efficacy analysis. One patient enrolled in the ACC cohort was excluded from the study due to change in the diagnosis.
Groups in this outcome
All Patients Who Received at Least One Dose of the Drug
MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
| Group | Source count |
|---|---|
| All Patients Who Received at Least One Dose of the Drug | 146 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Patients Who Received at Least One Dose of the Drug | 2.2 | Not reported | 2 | 2.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2
- upper Limit
- 2.7
- value
- 2.2
- denoms
- counts
- group Id
- OG000
- value
- 146
- units
- Participants
- description
- PFS was defined as the time from administration of the first dose to the first documented disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Patients who were alive and had not experienced disease progression at the time of data cutoff were censored.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- MK-3475: 200 mg of MK-3475 administered intravenously on Day 1 of every 21-day cycle
- id
- OG000
- title
- All Patients Who Received at Least One Dose of the Drug
- param Type
- MEDIAN
- population Description
- All patients who have received at least 1 dose of study medication with at least one adequate on-study tumor assessment were included in the efficacy analysis. If a patient discontinued the study before the first radiological assessment due to progression of disease, either radiological or clinical, they were considered evaluable and were included in the efficacy analysis. One patient enrolled in the ACC cohort was excluded from the study due to change in the diagnosis.
- reporting Status
- POSTED
- time Frame
- Baseline and every 9 weeks thereafter. After 6 months, every 12 weeks at the physician's discretion, if patient has had CR, PR, or SD > 27 weeks, an average of 4 years.
- title
- Progression-free Survival (PFS) Using RECIST v1.1
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle