NCT03521154 · OUTCOME
Proportion With Tumour Shrinkage 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
- Proportion of participants
- Interval / dispersion
- Not reported
- 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
Proportion with depth of response (or tumour shrinkage or change in tumour size)
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
Proportion with reduction
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib | 0.92 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0.83 | Not reported | Not reported | Not reported | Not reported |
Proportion with reduction > 30%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib | 0.65 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0.40 | Not reported | Not reported | Not reported | Not reported |
Proportion with reduction > 50%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib | 0.43 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0.11 | Not reported | Not reported | Not reported | Not reported |
Proportion with reduction > 75%
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib | 0.18 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 0.09 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0.92
- group Id
- OG001
- value
- 0.83
- title
- Proportion with reduction
- categories
- measurements
- group Id
- OG000
- value
- 0.65
- group Id
- OG001
- value
- 0.40
- title
- Proportion with reduction > 30%
- categories
- measurements
- group Id
- OG000
- value
- 0.43
- group Id
- OG001
- value
- 0.11
- title
- Proportion with reduction > 50%
- categories
- measurements
- group Id
- OG000
- value
- 0.18
- group Id
- OG001
- value
- 0.09
- title
- Proportion with reduction > 75%
- denoms
- counts
- group Id
- OG000
- value
- 143
- group Id
- OG001
- value
- 73
- units
- Participants
- description
- Proportion with depth of response (or tumour shrinkage or change in tumour size)
- 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
- Proportion With Tumour Shrinkage by Blinded Independent Central Review (BICR)
- type
- SECONDARY
- unit Of Measure
- Proportion of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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