TriangleNCT01784068 · OUTCOME
Treatment-Free Survival (TFS) After Start of the Treatment-Free Remission (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
- From start of the treatment-free remission (TFR) phase up to Week 528
What was measured
Treatment-free survival (TFS) was defined as the time from the start of the treatment-free remission (TFR) phase to the earliest occurrence of loss of major molecular response (MMR), reinitiation of treatment for any reason, progression to accelerated phase (AP) or blast crisis (BC), or death due to any cause. Participants without an event on or before the data cut-off date were censored at the date of their last available disease assessment (polymerase chain reaction, cytogenetic, hematologic, or extramedullary assessment).
Analysis population: The full analysis set (FAS) included all participants who completed 52 weeks of nilotinib treatment in the NTCS phase and subsequently entered the treatment-free remission (TFR) phase.
Groups in this outcome
TFR Phase
Participants who completed the nilotinib treatment consolidation (NTCS) phase and maintained major molecular response entered the treatment-free remission (TFR) phase. During the TFR phase, nilotinib treatment was discontinued and participants were monitored regularly for molecular response.
| Group | Source count |
|---|---|
| TFR Phase | 190 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| TFR Phase | 120.1 | Not reported | 36.9 | NA | the upper limit not estimable due to insufficient events |
Complete source fields
- classes
- categories
- measurements
- comment
- the upper limit not estimable due to insufficient events
- group Id
- OG000
- lower Limit
- 36.9
- upper Limit
- NA
- value
- 120.1
- denoms
- counts
- group Id
- OG000
- value
- 190
- units
- Participants
- description
- Treatment-free survival (TFS) was defined as the time from the start of the treatment-free remission (TFR) phase to the earliest occurrence of loss of major molecular response (MMR), reinitiation of treatment for any reason, progression to accelerated phase (AP) or blast crisis (BC), or death due to any cause. Participants without an event on or before the data cut-off date were censored at the date of their last available disease assessment (polymerase chain reaction, cytogenetic, hematologic, or extramedullary assessment).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who completed the nilotinib treatment consolidation (NTCS) phase and maintained major molecular response entered the treatment-free remission (TFR) phase. During the TFR phase, nilotinib treatment was discontinued and participants were monitored regularly for molecular response.
- id
- OG000
- title
- TFR Phase
- param Type
- MEDIAN
- population Description
- The full analysis set (FAS) included all participants who completed 52 weeks of nilotinib treatment in the NTCS phase and subsequently entered the treatment-free remission (TFR) phase.
- reporting Status
- POSTED
- time Frame
- From start of the treatment-free remission (TFR) phase up to Week 528
- title
- Treatment-Free Survival (TFS) After Start of the Treatment-Free Remission (TFR) Phase
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice