TriangleNCT02000427 · OUTCOME
Percentage of Participants With Complete Remission With Partial Hematological Recovery (CRh*) During the First Two Treatment Cycles
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
- Approximately 12 weeks, as of the data cut-off date of 20 May 2015
What was measured
Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete remission with partial hematological recovery (CRh\*) was defined as meeting all 3 of the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease; * partial recovery of peripheral blood counts: platelets \> 50,000/μl, and ANC \> 500/μl. Participants without a post-baseline disease assessment were considered non-responders.
Analysis population: All participants who received an infusion of blinatumomab
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 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.
| Group | Source count |
|---|---|
| Blinatumomab | 45 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Blinatumomab | 4.4 | Not reported | 0.5 | 15.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- upper Limit
- 15.1
- value
- 4.4
- denoms
- counts
- group Id
- OG000
- value
- 45
- units
- Participants
- description
- Participants were evaluated for efficacy at the end of each treatment cycle via a central bone marrow aspiration and local peripheral blood counts. Complete remission with partial hematological recovery (CRh\*) was defined as meeting all 3 of the following criteria: * less than or equal to 5% blasts in the bone marrow; * no evidence of disease; * partial recovery of peripheral blood counts: platelets \> 50,000/μl, and ANC \> 500/μl. Participants without a post-baseline disease assessment were considered non-responders.
- 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 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.
- id
- OG000
- title
- Blinatumomab
- param Type
- NUMBER
- population Description
- All participants who received an infusion of blinatumomab
- reporting Status
- POSTED
- time Frame
- Approximately 12 weeks, as of the data cut-off date of 20 May 2015
- title
- Percentage of Participants With Complete Remission With Partial Hematological Recovery (CRh*) During the First Two Treatment Cycles
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice