TriangleNCT01121588 · OUTCOME
Progression-Free Survival (PFS) Based on Investigator Assessement
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 date of first dose of study medication to the date of the first documentation of objective tumor progression or death on treatment due to any cause, whichever occurs first (maximum 444 weeks)
What was measured
PFS was defined as the time from the date of first dose of study medication to the date of the first documentation of objective tumor progression (at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study \[this includes the baseline sum if that is the smallest on study\]). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered a sign of progression) or death on treatment due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. The median PFS was estimated using Kaplan-Meier method.
Analysis population: All 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 | 2.1 | NA | Median PFS and upper limit of Confidence Interval not estimable due to insufficient number of participants with event. |
| IMT Arm | NA | Not reported | 11.1 | NA | Median PFS and upper limit of Confidence Interval not estimable due to insufficient number of participants with event. |
| Other Tumors | 1.4 | Not reported | 1.1 | 4.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Median PFS and upper limit of Confidence Interval not estimable due to insufficient number of participants with event.
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- NA
- value
- NA
- comment
- Median PFS and upper limit of Confidence Interval not estimable due to insufficient number of participants with event.
- group Id
- OG001
- lower Limit
- 11.1
- upper Limit
- NA
- value
- NA
- group Id
- OG002
- lower Limit
- 1.1
- upper Limit
- 4.9
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 18
- units
- Participants
- description
- PFS was defined as the time from the date of first dose of study medication to the date of the first documentation of objective tumor progression (at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study \[this includes the baseline sum if that is the smallest on study\]). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered a sign of progression) or death on treatment due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. The median PFS 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
- All enrolled participants who received at least 1 dose of study treatment.
- reporting Status
- POSTED
- time Frame
- From the date of first dose of study medication to the date of the first documentation of objective tumor progression or death on treatment due to any cause, whichever occurs first (maximum 444 weeks)
- title
- Progression-Free Survival (PFS) Based on Investigator Assessement
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice