TriangleNCT02807636 · OUTCOME
Duration of Response (DOR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
What was measured
Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first.
Analysis population: The duration of response (DOR)-evaluable population is defined as participants with an objective response in the the ITT population which included only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6.
Groups in this outcome
Placebo+Gemcitabine+Carboplatin/Cisplatin
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
| Group | Source count |
|---|---|
| Placebo+Gemcitabine+Carboplatin/Cisplatin | 158 |
| Atezolizumab Monotherapy | 87 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo+Gemcitabine+Carboplatin/Cisplatin | 8.11 | Not reported | 6.28 | 8.54 | Not reported |
| Atezolizumab Monotherapy | 29.63 | Not reported | 15.90 | NA | Upper CI limit is not evaluable because there were not enough events at later time to get a reliable upper CI. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.28
- upper Limit
- 8.54
- value
- 8.11
- comment
- Upper CI limit is not evaluable because there were not enough events at later time to get a reliable upper CI.
- group Id
- OG001
- lower Limit
- 15.90
- upper Limit
- NA
- value
- 29.63
- denoms
- counts
- group Id
- OG000
- value
- 158
- group Id
- OG001
- value
- 87
- units
- Participants
- description
- Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
- id
- OG000
- title
- Placebo+Gemcitabine+Carboplatin/Cisplatin
- description
- Eligible participants received open-label atezolizumab as monotherapy.
- id
- OG001
- title
- Atezolizumab Monotherapy
- param Type
- NUMBER
- population Description
- The duration of response (DOR)-evaluable population is defined as participants with an objective response in the the ITT population which included only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6.
- reporting Status
- POSTED
- time Frame
- From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
- title
- Duration of Response (DOR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice