TriangleNCT01121588 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the first dose of study treatment to the date of death due to any cause (maximum 444 weeks)
What was measured
OS is defined as the time from the date of first dose of study medication to the date of death due to any cause. OS (in months) was calculated as (date of death - date of first dose +1)/30.42. For participants still alive at the time of the analysis, for those who were lost to follow-up, and those who withdrew consent for additional follow up, the OS was censored on the last date that participants were known to be alive. Participants lacking data beyond the first dose had their OS censored at the date of first dose. The median OS was estimated using Kaplan-Meier method.
Analysis population: Enrolled participants who received at least 1 dose of study treatment.
Groups in this outcome
ALCL Arm
In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
IMT Arm
In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
Other Tumors
In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
| Group | Source count |
|---|---|
| ALCL Arm | 17 |
| IMT Arm | 9 |
| Other Tumors | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALCL Arm | NA | Not reported | 7.5 | NA | Median OS and upper limit of Confidence Interval not estimable due to insufficient number of participants with event. |
| IMT Arm | NA | Not reported | 32.1 | NA | Median OS and upper limit of Confidence Interval not estimable due to insufficient number of participants with event. |
| Other Tumors | 12.6 | Not reported | 2.2 | 27.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Median OS and upper limit of Confidence Interval not estimable due to insufficient number of participants with event.
- group Id
- OG000
- lower Limit
- 7.5
- upper Limit
- NA
- value
- NA
- comment
- Median OS and upper limit of Confidence Interval not estimable due to insufficient number of participants with event.
- group Id
- OG001
- lower Limit
- 32.1
- upper Limit
- NA
- value
- NA
- group Id
- OG002
- lower Limit
- 2.2
- upper Limit
- 27.0
- value
- 12.6
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 18
- units
- Participants
- description
- OS is defined as the time from the date of first dose of study medication to the date of death due to any cause. OS (in months) was calculated as (date of death - date of first dose +1)/30.42. For participants still alive at the time of the analysis, for those who were lost to follow-up, and those who withdrew consent for additional follow up, the OS was censored on the last date that participants were known to be alive. Participants lacking data beyond the first dose had their OS censored at the date of first dose. The median OS was estimated using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- OG000
- title
- ALCL Arm
- description
- In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- OG001
- title
- IMT Arm
- description
- In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
- id
- OG002
- title
- Other Tumors
- param Type
- MEDIAN
- population Description
- Enrolled participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- From the first dose of study treatment to the date of death due to any cause (maximum 444 weeks)
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice