NCT01207388 · OUTCOME
Time to Hematological Relapse
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
- Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.
What was measured
Time to hematological relapse was measured from the start of treatment with blinatumomab until hematological or extramedullary relapse. Participants who died or received HSCT or post-blinatumomab chemotherapy after treatment with blinatumomab were censored at their last hematological assessment prior to death or HSCT or post-blinatumomab chemotherapy (whichever occurred first).
Analysis population: Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.
Groups in this outcome
Blinatumomab
Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
| Group | Source count |
|---|---|
| Blinatumomab | 110 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Blinatumomab | NA | Not reported | 7.1 | NA | Data not estimable due to the low number of events |
Complete source fields
- classes
- categories
- measurements
- comment
- Data not estimable due to the low number of events
- group Id
- OG000
- lower Limit
- 7.1
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 110
- units
- Participants
- description
- Time to hematological relapse was measured from the start of treatment with blinatumomab until hematological or extramedullary relapse. Participants who died or received HSCT or post-blinatumomab chemotherapy after treatment with blinatumomab were censored at their last hematological assessment prior to death or HSCT or post-blinatumomab chemotherapy (whichever occurred first).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
- id
- OG000
- title
- Blinatumomab
- param Type
- MEDIAN
- population Description
- Full analysis set participants who were in hematological complete remission at treatment start, excluding Philadelphia-positive participants.
- reporting Status
- POSTED
- time Frame
- Until the data cut-off date of 05 August 2015; median time on study was 18.3 months.
- title
- Time to Hematological Relapse
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle