NCT02486718 · OUTCOME
Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population
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
- Year 5
What was measured
DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
Analysis population: Stage II-IIIA population was defined as all randomized participants with extent of disease as either Stage II or Stage III, and is a subset of the ITT population. Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.
Groups in this outcome
Atezolizumab
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
Best Supportive Care (BSC)
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
| Group | Source count |
|---|---|
| Atezolizumab | 442 |
| Best Supportive Care (BSC) | 440 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Atezolizumab | 49.28 | Not reported | 44.47 | 54.10 | Not reported |
| Best Supportive Care (BSC) | 44.40 | Not reported | 39.57 | 49.24 | Not reported |
Source statistical analyses
- ci Lower Limit
- -1.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.70
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in event-free rates
- param Value
- 4.88
Complete source fields
- analyses
- ci Lower Limit
- -1.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 11.70
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Difference in event-free rates
- param Value
- 4.88
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 44.47
- upper Limit
- 54.10
- value
- 49.28
- group Id
- OG001
- lower Limit
- 39.57
- upper Limit
- 49.24
- value
- 44.40
- denoms
- counts
- group Id
- OG000
- value
- 442
- group Id
- OG001
- value
- 440
- units
- Participants
- description
- DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
- id
- OG000
- title
- Atezolizumab
- description
- Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
- id
- OG001
- title
- Best Supportive Care (BSC)
- param Type
- NUMBER
- population Description
- Stage II-IIIA population was defined as all randomized participants with extent of disease as either Stage II or Stage III, and is a subset of the ITT population. Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.
- reporting Status
- POSTED
- time Frame
- Year 5
- title
- Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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