TriangleNCT02807636 · OUTCOME
Objective Response Rate (ORR) 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
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
What was measured
Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments \>= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline.
Analysis population: The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6. The measurable disease populations were defined as participants in the respective ITT populations with at least one measurable lesion according to RECIST v1.1 based on investigator assessment.
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 | 356 |
| Atezolizumab Monotherapy | 359 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo+Gemcitabine+Carboplatin/Cisplatin | 44.4 | Not reported | 39.15 | 49.71 | Not reported |
| Atezolizumab Monotherapy | 24.2 | Not reported | 19.89 | 29.01 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 39.15
- upper Limit
- 49.71
- value
- 44.4
- group Id
- OG001
- lower Limit
- 19.89
- upper Limit
- 29.01
- value
- 24.2
- denoms
- counts
- group Id
- OG000
- value
- 356
- group Id
- OG001
- value
- 359
- units
- Participants
- description
- Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments \>= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline.
- 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 ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6. The measurable disease populations were defined as participants in the respective ITT populations with at least one measurable lesion according to RECIST v1.1 based on investigator assessment.
- reporting Status
- POSTED
- time Frame
- Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)
- title
- Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice