TriangleNCT01736683 · OUTCOME
Number of Participants Who Achieved Red Blood Cell (RBC)-Transfusion Independence During the Erythroid Hematological Improvement (HI-E) Interval
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Day 2 to Day 142
What was measured
Number of participants who achieved RBC-independence was defined as participants who required no RBC-transfusions during a 56-day interval of erythroid hematological improvement (HI-E). NTDE = non-transfusion dependence efficacy participants who required \< 4 units of RBCs in the 8 weeks prior to start of therapy TDE = transfusion dependence efficacy participants who required \>=4 units of RBCs in the 8 weeks prior to start of therapy
Analysis population: Efficacy Evaluable Population
Groups in this outcome
Sotatercept 0.1 mg/kg
Sotatercept 0.1 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
Sotatercept 0.3 mg/kg
Sotatercept 0.3 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
Sotatercept 0.5 mg/kg
Sotatercept 0.5 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 0.5 mg/kg treatment group, the 1.0 mg/kg treatment group began inclusion in the randomization scheme.
Sotatercept 1.0 mg/kg
Sotatercept 1.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 1.0 mg/kg treatment group, the 2.0 mg/kg treatment group began inclusion in the randomization scheme. Following evaluation of all treatment group data by the Steering Committee, enrollment continued only in the 1.0 mg/kg arm because the arm had the greatest frequency of erythroid hematological improvement (HI-E).
Sotatercept 2.0 mg/kg
Sotatercept 2.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. The 2.0 mg/kg sotatercept dose was reduced to 1.5 mg/kg for ongoing and newly enrolled participants by protocol amendment.
| Group | Source count |
|---|---|
| Sotatercept 0.1 mg/kg | 7 |
| Sotatercept 0.3 mg/kg | 6 |
| Sotatercept 0.5 mg/kg | 21 |
| Sotatercept 1.0 mg/kg | 35 |
| Sotatercept 2.0 mg/kg | 5 |
Reported measurements
All participants
| Group | Source count |
|---|---|
| Sotatercept 0.1 mg/kg | 7 |
| Sotatercept 0.3 mg/kg | 6 |
| Sotatercept 0.5 mg/kg | 21 |
| Sotatercept 1.0 mg/kg | 35 |
| Sotatercept 2.0 mg/kg | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sotatercept 0.1 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 0.3 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 0.5 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 1.0 mg/kg | 15 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
NTDE subpopulation
| Group | Source count |
|---|---|
| Sotatercept 0.1 mg/kg | 0 |
| Sotatercept 0.3 mg/kg | 0 |
| Sotatercept 0.5 mg/kg | 3 |
| Sotatercept 1.0 mg/kg | 8 |
| Sotatercept 2.0 mg/kg | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sotatercept 0.5 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 1.0 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
TDE subpopulation
| Group | Source count |
|---|---|
| Sotatercept 0.1 mg/kg | 7 |
| Sotatercept 0.3 mg/kg | 6 |
| Sotatercept 0.5 mg/kg | 18 |
| Sotatercept 1.0 mg/kg | 27 |
| Sotatercept 2.0 mg/kg | 4 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sotatercept 0.1 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 0.3 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 0.5 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 1.0 mg/kg | 9 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 35
- group Id
- OG004
- value
- 5
- units
- Participants
- title
- All participants
- categories
- measurements
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 8
- group Id
- OG004
- value
- 1
- units
- Participants
- title
- NTDE subpopulation
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 27
- group Id
- OG004
- value
- 4
- units
- Participants
- title
- TDE subpopulation
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 35
- group Id
- OG004
- value
- 5
- units
- Participants
- description
- Number of participants who achieved RBC-independence was defined as participants who required no RBC-transfusions during a 56-day interval of erythroid hematological improvement (HI-E). NTDE = non-transfusion dependence efficacy participants who required \< 4 units of RBCs in the 8 weeks prior to start of therapy TDE = transfusion dependence efficacy participants who required \>=4 units of RBCs in the 8 weeks prior to start of therapy
- groups
- description
- Sotatercept 0.1 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
- id
- OG000
- title
- Sotatercept 0.1 mg/kg
- description
- Sotatercept 0.3 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
- id
- OG001
- title
- Sotatercept 0.3 mg/kg
- description
- Sotatercept 0.5 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 0.5 mg/kg treatment group, the 1.0 mg/kg treatment group began inclusion in the randomization scheme.
- id
- OG002
- title
- Sotatercept 0.5 mg/kg
- description
- Sotatercept 1.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 1.0 mg/kg treatment group, the 2.0 mg/kg treatment group began inclusion in the randomization scheme. Following evaluation of all treatment group data by the Steering Committee, enrollment continued only in the 1.0 mg/kg arm because the arm had the greatest frequency of erythroid hematological improvement (HI-E).
- id
- OG003
- title
- Sotatercept 1.0 mg/kg
- description
- Sotatercept 2.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. The 2.0 mg/kg sotatercept dose was reduced to 1.5 mg/kg for ongoing and newly enrolled participants by protocol amendment.
- id
- OG004
- title
- Sotatercept 2.0 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Efficacy Evaluable Population
- reporting Status
- POSTED
- time Frame
- Day 2 to Day 142
- title
- Number of Participants Who Achieved Red Blood Cell (RBC)-Transfusion Independence During the Erythroid Hematological Improvement (HI-E) Interval
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice