NCT01774721 · OUTCOME
OS at 30 Months (OS30m)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- probability of survival
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to 30 months from date of randomization
What was measured
OS30m was defined as the probability of a participant being alive at 30 months from date of randomization.
Analysis population: ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
Groups in this outcome
Dacomitinib
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Gefitinib
Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
| Group | Source count |
|---|---|
| Dacomitinib | 227 |
| Gefitinib | 225 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dacomitinib | 56.4 | Not reported | 49.6 | 62.7 | Not reported |
| Gefitinib | 45.7 | Not reported | 39.0 | 52.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 49.6
- upper Limit
- 62.7
- value
- 56.4
- group Id
- OG001
- lower Limit
- 39.0
- upper Limit
- 52.2
- value
- 45.7
- denoms
- counts
- group Id
- OG000
- value
- 227
- group Id
- OG001
- value
- 225
- units
- Participants
- description
- OS30m was defined as the probability of a participant being alive at 30 months from date of randomization.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
- id
- OG000
- title
- Dacomitinib
- description
- Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, for maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
- id
- OG001
- title
- Gefitinib
- param Type
- NUMBER
- population Description
- ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
- reporting Status
- POSTED
- time Frame
- Up to 30 months from date of randomization
- title
- OS at 30 Months (OS30m)
- type
- SECONDARY
- unit Of Measure
- probability of survival
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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