TriangleNCT01784068 · OUTCOME
Percentage of Participants Who Achieved Major Molecular Response (MMR) Within 12 Weeks of Reinitiation of Nilotinib Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 12 weeks after reinitiation of nilotinib treatment
What was measured
Percentage of patients who achieved MMR within 12 weeks of re-initiation of treatment with nilotinib defined as the number of patients who were in MMR at least at 1 assessment within 12 weeks after re-start of nilotinib treatment divided by the number of patients who were re-initiated for at least 12 weeks.
Analysis population: The nilotinib treatment reinitiation (NTRI) safety set included all participants who received at least one dose of study medication during the nilotinib treatment reinitiation phase. Reinitiation of nilotinib occurred when participants experienced loss of MMR during the treatment-free remission (TFR) phase. Only patients who had at least 12 weeks of re-initiation of treatment with nilotinib were included in the analysis.
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 | 87 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NTRI Phase | 95.4 | Not reported | 88.6 | 98.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 88.6
- upper Limit
- 98.7
- value
- 95.4
- denoms
- counts
- group Id
- OG000
- value
- 87
- units
- Participants
- description
- Percentage of patients who achieved MMR within 12 weeks of re-initiation of treatment with nilotinib defined as the number of patients who were in MMR at least at 1 assessment within 12 weeks after re-start of nilotinib treatment divided by the number of patients who were re-initiated for at least 12 weeks.
- 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
- NUMBER
- population Description
- The nilotinib treatment reinitiation (NTRI) safety set included all participants who received at least one dose of study medication during the nilotinib treatment reinitiation phase. Reinitiation of nilotinib occurred when participants experienced loss of MMR during the treatment-free remission (TFR) phase. Only patients who had at least 12 weeks of re-initiation of treatment with nilotinib were included in the analysis.
- reporting Status
- POSTED
- time Frame
- 12 weeks after reinitiation of nilotinib treatment
- title
- Percentage of Participants Who Achieved Major Molecular Response (MMR) Within 12 Weeks of Reinitiation of Nilotinib Treatment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice