TriangleNCT01466179 · OUTCOME
Time to Hematological Relapse (Duration of Response)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Up to the data cut-off date of 10 October 2013; median observation time was 8.0 months.
What was measured
Time to hematological relapse was measured for participants in remission during the core study (the time from the first infusion through 30 days after the last infusion), from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death. Hematological relapse is defined as: * proportion of blasts in bone marrow \> 5% after documented CR/CRh\* or * blasts in peripheral blood after documented CR/CRh\*. Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method.
Analysis population: Participants who reached complete remission or complete remission with partial hematological recovery during the core study.
Groups in this outcome
Blinatumomab
Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
| Group | Source count |
|---|---|
| Blinatumomab | 82 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Blinatumomab | 6.7 | Not reported | 5.1 | NA | Not estimable due to the number of events during the observation period. |
Complete source fields
- classes
- categories
- measurements
- comment
- Not estimable due to the number of events during the observation period.
- group Id
- OG000
- lower Limit
- 5.1
- upper Limit
- NA
- value
- 6.7
- denoms
- counts
- group Id
- OG000
- value
- 82
- units
- Participants
- description
- Time to hematological relapse was measured for participants in remission during the core study (the time from the first infusion through 30 days after the last infusion), from the time the participant first achieved remission until first documented relapse or death due to disease progression. Participants without documented relapse (hematological or extramedullary) and who did not die were censored at the time of their last bone marrow assessment or their last survival follow-up visit confirming remission. Participants who died without having reported hematological relapse or without showing any clinical sign of disease progression were censored on their date of death. Hematological relapse is defined as: * proportion of blasts in bone marrow \> 5% after documented CR/CRh\* or * blasts in peripheral blood after documented CR/CRh\*. Time to hematological relapse was analyzed by Kaplan-Meier methods and the median observation time was calculated by the reverse Kaplan Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
- id
- OG000
- title
- Blinatumomab
- param Type
- MEDIAN
- population Description
- Participants who reached complete remission or complete remission with partial hematological recovery during the core study.
- reporting Status
- POSTED
- time Frame
- Up to the data cut-off date of 10 October 2013; median observation time was 8.0 months.
- title
- Time to Hematological Relapse (Duration of Response)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice