TriangleNCT02639559 · OUTCOME
Cumulative Incidence of Grade 2-4 Acute Graft Versus Host Disease (GvHD) as Measured by Minnesota Acute GVHD Criteria (Arm 2 Recipients Only)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 100
What was measured
* Acute GVHD rate and worst severity is noted * 4 organ categories (skin, liver, lower GI, and upper GI) * Skin: Grade I: 1-2 , Grade II: 3, Grade III: N/A, Grade IV: 4 * Liver: Grade I: 0, Grade II: 1, Grade III: 2-4, Grade IV: N/A * Lower GI: Grade I: 0, Grade II: 1: Grade II: 2-3: Grade IV: 4 * Upper GI: Grade I: 0, Grade II: 1, Grade III: N/A, Grade IV: N/A * The cumulative incidence of grade 2-4 acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death, relapse, and graft failure.
Analysis population: -Donors are not evaluable for this outcome measure.
Groups in this outcome
Arm 1: Donors
-Donors will receive subcutaneous (SC) BL-8040 in the morning (Day 1) followed by leukapheresis approximately 180 minutes (up to 270 minutes) after the injection per institutional protocol. If the donor does not reach the collection goal for mobilization (≥ 5.0 x 10\^6 CD34+ cells/kg), a second leukapheresis will be performed on Day 2 (24 hours ± 2 hours from the BL-8040 injection) in an effort to reach a total of ≥ 5 x 10\^6 CD34+ cells/kg and at least ≥ 2 x 10\^6 CD34+ cells/kg from the combined collections.
Arm 2: Recipients
-All or part of the leukapheresis product will be infused into the recipient per institutional guidelines. The day of the infusion will be considered Day 0; if the infusion occurs over multiple days, the final day of infusion will be considered Day 0
| Group | Source count |
|---|---|
| Arm 1: Donors | 0 |
| Arm 2: Recipients | 22 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 2: Recipients | 0.3636 | Not reported | 0.1690 | 0.5623 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 0.1690
- upper Limit
- 0.5623
- value
- 0.3636
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 22
- units
- Participants
- description
- * Acute GVHD rate and worst severity is noted * 4 organ categories (skin, liver, lower GI, and upper GI) * Skin: Grade I: 1-2 , Grade II: 3, Grade III: N/A, Grade IV: 4 * Liver: Grade I: 0, Grade II: 1, Grade III: 2-4, Grade IV: N/A * Lower GI: Grade I: 0, Grade II: 1: Grade II: 2-3: Grade IV: 4 * Upper GI: Grade I: 0, Grade II: 1, Grade III: N/A, Grade IV: N/A * The cumulative incidence of grade 2-4 acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death, relapse, and graft failure.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- -Donors will receive subcutaneous (SC) BL-8040 in the morning (Day 1) followed by leukapheresis approximately 180 minutes (up to 270 minutes) after the injection per institutional protocol. If the donor does not reach the collection goal for mobilization (≥ 5.0 x 10\^6 CD34+ cells/kg), a second leukapheresis will be performed on Day 2 (24 hours ± 2 hours from the BL-8040 injection) in an effort to reach a total of ≥ 5 x 10\^6 CD34+ cells/kg and at least ≥ 2 x 10\^6 CD34+ cells/kg from the combined collections.
- id
- OG000
- title
- Arm 1: Donors
- description
- -All or part of the leukapheresis product will be infused into the recipient per institutional guidelines. The day of the infusion will be considered Day 0; if the infusion occurs over multiple days, the final day of infusion will be considered Day 0
- id
- OG001
- title
- Arm 2: Recipients
- param Type
- NUMBER
- population Description
- -Donors are not evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Day 100
- title
- Cumulative Incidence of Grade 2-4 Acute Graft Versus Host Disease (GvHD) as Measured by Minnesota Acute GVHD Criteria (Arm 2 Recipients Only)
- type
- SECONDARY
- unit Of Measure
- proportion of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice