TriangleNCT00109707 · OUTCOME
Time to Progression (TTP) (Phase II)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Up to End of the Treatment (Approximately 7.5 years)
What was measured
Time to Progression was defined as the time from the start of nilotinib to the earliest date of Disease Progression (PD), discontinuation due to PD or death. Disease progression was defined as an increase in the number of circulating leukemic cells via cytogenetic assessment using real-time quantitative reverse transcriptase polymerase chain reaction (PCR).
Analysis population: Full Analysis Set (FAS): All participants who received at least one dose of study medication. Time to progression was not an efficacy variable for participants who received the CML-CP with prior imatinib and other TKI (Group B E8).
Groups in this outcome
CML-CP With Prior Imatinib Only
Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
CML-AP With Prior Imatinib Only
Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
| Group | Source count |
|---|---|
| CML-CP With Prior Imatinib Only | 321 |
| CML-AP With Prior Imatinib Only | 137 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CML-CP With Prior Imatinib Only | 55.6 | Not reported | 0.1 | 77.8 | Not reported |
| CML-AP With Prior Imatinib Only | 15.9 | Not reported | 0.1 | 75.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.1
- upper Limit
- 77.8
- value
- 55.6
- group Id
- OG001
- lower Limit
- 0.1
- upper Limit
- 75.7
- value
- 15.9
- denoms
- counts
- group Id
- OG000
- value
- 321
- group Id
- OG001
- value
- 137
- units
- Participants
- description
- Time to Progression was defined as the time from the start of nilotinib to the earliest date of Disease Progression (PD), discontinuation due to PD or death. Disease progression was defined as an increase in the number of circulating leukemic cells via cytogenetic assessment using real-time quantitative reverse transcriptase polymerase chain reaction (PCR).
- dispersion Type
- Full Range
- groups
- description
- Adult participants PH+ CML-CP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
- id
- OG000
- title
- CML-CP With Prior Imatinib Only
- description
- Adult participants Ph+ CML-AP without prior TKI treatment with either resistant / intolerant to Imatinib received 400 mg Nilotinib orally twice daily up to the end of treatment (September-2012).
- id
- OG001
- title
- CML-AP With Prior Imatinib Only
- param Type
- MEDIAN
- population Description
- Full Analysis Set (FAS): All participants who received at least one dose of study medication. Time to progression was not an efficacy variable for participants who received the CML-CP with prior imatinib and other TKI (Group B E8).
- reporting Status
- POSTED
- time Frame
- Up to End of the Treatment (Approximately 7.5 years)
- title
- Time to Progression (TTP) (Phase II)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice