TriangleNCT01698905 · OUTCOME
Overall Survival (OS) After the Start of the TFR Phase
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- nilotinib cessation up to approximately 580 weeks
What was measured
Overall survival, defined as the time from start date of TFR (date of entering the TFR phase) to date of death due to any cause at any time during the study, including the follow-up period after discontinuation of study up to LPLV. If a patient is not known to have died, survival will be censored at the date of last contact.
Analysis population: Full analysis set (FAS) included all patients who completed the consolidation phase successfully and entered the TFR phase.
Groups in this outcome
TFS Phase
TFR is defined as no confirmed loss of MR4 (Molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL \> 0.01% IS. Loss of MMR does not require confirmation.
| Group | Source count |
|---|---|
| TFS Phase | 126 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TFS Phase | NA | Not reported | NA | NA | insufficient number of participants with events |
Complete source fields
- classes
- categories
- measurements
- comment
- insufficient number of participants with events
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 126
- units
- Participants
- description
- Overall survival, defined as the time from start date of TFR (date of entering the TFR phase) to date of death due to any cause at any time during the study, including the follow-up period after discontinuation of study up to LPLV. If a patient is not known to have died, survival will be censored at the date of last contact.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- TFR is defined as no confirmed loss of MR4 (Molecular response 4.0 log reduction from baseline) or loss of MMR (major molecular response) and no re-starting of nilotinib therapy within 12 months following cessation of nilotinib. Confirmed loss of MR4 is two consecutive BCR-ABL \> 0.01% IS. Loss of MMR does not require confirmation.
- id
- OG000
- title
- TFS Phase
- param Type
- MEDIAN
- population Description
- Full analysis set (FAS) included all patients who completed the consolidation phase successfully and entered the TFR phase.
- reporting Status
- POSTED
- time Frame
- nilotinib cessation up to approximately 580 weeks
- title
- Overall Survival (OS) After the Start of the TFR Phase
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice