TriangleNCT02504372 · OUTCOME
Disease-Free Survival (DFS)
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 approximately 84 months
What was measured
DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.
Analysis population: All randomized participants. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
Groups in this outcome
Pembrolizumab
Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
Placebo
Participants received placebo, IV, every 3 weeks, for one year.
| Group | Source count |
|---|---|
| Pembrolizumab | 590 |
| Placebo | 587 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab | 53.8 | Not reported | 46.2 | 67.0 | Not reported |
| Placebo | 43.0 | Not reported | 35.0 | 51.6 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.96
- estimate Comment
- HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.81
Complete source fields
- analyses
- ci Lower Limit
- 0.68
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.96
- estimate Comment
- HR and 95% confidence interval (95%CI) were based on multivariate Cox regression model with treatment adjusted by stage, PD-L1 status, adjuvant chemotherapy, region, histology, and smoking status.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.81
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 46.2
- upper Limit
- 67.0
- value
- 53.8
- group Id
- OG001
- lower Limit
- 35.0
- upper Limit
- 51.6
- value
- 43.0
- denoms
- counts
- group Id
- OG000
- value
- 590
- group Id
- OG001
- value
- 587
- units
- Participants
- description
- DFS was defined as the time from randomization to either the date of disease recurrence or death (whatever the cause) as assessed by the investigator. Recurrence of disease was defined as local regional recurrence, a distant (metastatic) recurrence, or a second primary cancer. Occurrence of a second extra-pulmonary malignancy was considered to be an event.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg, intravenously (IV), every 3 weeks, for one year.
- id
- OG000
- title
- Pembrolizumab
- description
- Participants received placebo, IV, every 3 weeks, for one year.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- All randomized participants. One participant randomized to the study in error did not provide informed consent and was not included. No data was collected on this participant.
- reporting Status
- POSTED
- time Frame
- Up to approximately 84 months
- title
- Disease-Free Survival (DFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice