NCT03521154 · OUTCOME
Disease Control Rate by Blinded Independent Central Review (BICR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- % of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
What was measured
Percentage of patients who have a best overall response of complete response (CR), partial response (PR) or stable disease (SD) as assessed by BICR
Analysis population: Full analysis set
Groups in this outcome
Osimertinib
80mg once daily tablet
Placebo
Matching Placebo
| Group | Source count |
|---|---|
| Osimertinib | 143 |
| Placebo | 73 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib | 88.8 | Not reported | 82.5 | 93.5 | Not reported |
| Placebo | 79.5 | Not reported | 68.4 | 88.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.47
- estimate Comment
- An odds ratio \> 1 favours osimertinib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.069
- param Type
- Odds Ratio (OR)
- param Value
- 2.06
- statistical Method
- Regression, Logistic
Complete source fields
- analyses
- ci Lower Limit
- 0.94
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.47
- estimate Comment
- An odds ratio \> 1 favours osimertinib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.069
- param Type
- Odds Ratio (OR)
- param Value
- 2.06
- statistical Method
- Regression, Logistic
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 82.5
- upper Limit
- 93.5
- value
- 88.8
- group Id
- OG001
- lower Limit
- 68.4
- upper Limit
- 88.0
- value
- 79.5
- denoms
- counts
- group Id
- OG000
- value
- 143
- group Id
- OG001
- value
- 73
- units
- Participants
- description
- Percentage of patients who have a best overall response of complete response (CR), partial response (PR) or stable disease (SD) as assessed by BICR
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 80mg once daily tablet
- id
- OG000
- title
- Osimertinib
- description
- Matching Placebo
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- Full analysis set
- reporting Status
- POSTED
- time Frame
- Every 8 weeks for first 48 weeks, then every 12 weeks until BICR-confirmed radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
- title
- Disease Control Rate by Blinded Independent Central Review (BICR)
- type
- SECONDARY
- unit Of Measure
- % of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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