NCT03521154 · OUTCOME
Duration of Response, Unconfirmed 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
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Every 8 weeks for first 48 weeks, then every 12 weeks until radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
What was measured
Date of PFS event - date of first unconfirmed response + 1 day (and expressed in months) for unconfirmed responses only
Analysis population: Full analysis set
Groups in this outcome
Osimertinib
80mg once daily tablet
Placebo
Matching Placebo
| Group | Source count |
|---|---|
| Osimertinib | 82 |
| Placebo | 24 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Osimertinib | 36.9 | Not reported | 17.9 | NA | NA - Not calculated as insufficient number of events to enable 75% percentile to be calculated |
| Placebo | 6.5 | Not reported | 3.2 | 9.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- NA - Not calculated as insufficient number of events to enable 75% percentile to be calculated
- group Id
- OG000
- lower Limit
- 17.9
- upper Limit
- NA
- value
- 36.9
- group Id
- OG001
- lower Limit
- 3.2
- upper Limit
- 9.0
- value
- 6.5
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 24
- units
- Participants
- description
- Date of PFS event - date of first unconfirmed response + 1 day (and expressed in months) for unconfirmed responses only
- dispersion Type
- Inter-Quartile Range
- groups
- description
- 80mg once daily tablet
- id
- OG000
- title
- Osimertinib
- description
- Matching Placebo
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- Full analysis set
- reporting Status
- POSTED
- time Frame
- Every 8 weeks for first 48 weeks, then every 12 weeks until radiological disease progression. Assessed up to date of DCO (05Jan24) to a maximum of approximately 63 months
- title
- Duration of Response, Unconfirmed by Blinded Independent Central Review (BICR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle