TriangleNCT01784068 · OUTCOME
Duration of Re-Initiated Nilotinib Treatment Required to Regain Molecular Response 4.5 (MR4.5) After Loss of MMR
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 Nilotinib treatment re-initiation up to Week 528
What was measured
This outcome measure was defined as the time from the date of reinitiation of nilotinib treatment following loss of major molecular response (MMR) to the date of first documented achievement of molecular response 4.5 (MR4.5). Participants who did not regain MR4.5 after reinitiation of treatment on or before the data cut-off date were censored at the date of their last available BCR-ABN PCR assessment. MR4.5 corresponds to a BCR-ABN transcript level ≤0.0032% on the International Scale (IS).
Analysis population: The nilotinib treatment re-initiation (NTRI) safety set included all participants who received at least one dose of study medication during the nilotinib treatment re-initiation phase.
Groups in this outcome
NTRI Phase
Participants who experienced loss of major molecular response during the treatment-free remission (TFR) phase entered the nilotinib treatment re-initiation (NTRI) phase. During this phase, nilotinib treatment was re-initiated at a dose of 300 mg twice daily.
| Group | Source count |
|---|---|
| NTRI Phase | 91 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NTRI Phase | 12.9 | Not reported | 12.1 | 15.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.1
- upper Limit
- 15.1
- value
- 12.9
- denoms
- counts
- group Id
- OG000
- value
- 91
- units
- Participants
- description
- This outcome measure was defined as the time from the date of reinitiation of nilotinib treatment following loss of major molecular response (MMR) to the date of first documented achievement of molecular response 4.5 (MR4.5). Participants who did not regain MR4.5 after reinitiation of treatment on or before the data cut-off date were censored at the date of their last available BCR-ABN PCR assessment. MR4.5 corresponds to a BCR-ABN transcript level ≤0.0032% on the International Scale (IS).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who experienced loss of major molecular response during the treatment-free remission (TFR) phase entered the nilotinib treatment re-initiation (NTRI) phase. During this phase, nilotinib treatment was re-initiated at a dose of 300 mg twice daily.
- id
- OG000
- title
- NTRI Phase
- param Type
- MEDIAN
- population Description
- The nilotinib treatment re-initiation (NTRI) safety set included all participants who received at least one dose of study medication during the nilotinib treatment re-initiation phase.
- reporting Status
- POSTED
- time Frame
- From start of Nilotinib treatment re-initiation up to Week 528
- title
- Duration of Re-Initiated Nilotinib Treatment Required to Regain Molecular Response 4.5 (MR4.5) After Loss of MMR
- type
- SECONDARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice