TriangleNCT01736683 · OUTCOME
Percentage of Participants With Erythroid Hematological Improvement (HI-E) Starting Before the Completion of Five Cycles of Treatment (Responder Rate)
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
- Not reported
- Time frame
- Day 2 to Day 142
What was measured
The responder rate includes non-transfusion dependent efficacy (NTDE) participants and transfusion dependent efficacy (TDE) participants. For non-transfusion dependence efficacy (NTDE) participants who required \< 4 units of RBCs in the 8 weeks prior to start of therapy, HI-E was defined as an increase of \>=1.5 g/dL hemoglobin sustained for 56 days over a period of \>=8 weeks. For transfusion dependence efficacy (TDE) participants who required \>=4 units of RBCs in the 8 weeks prior to start of therapy, HI-E was defined as a decrease of \>= 4 units of RBCs transfused sustained for 56 days over a period of 8 weeks.
Analysis population: Efficacy Evaluable Population: all participants who take at least one dose of study medication and have baseline and at least one post-baseline assessment of efficacy without major deviation from protocol.
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 | 66.7 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 0.5 mg/kg | 42.9 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 1.0 mg/kg | 60.0 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 40.0 | 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 | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 1.0 mg/kg | 62.5 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 100 | 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 | 66.7 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 0.5 mg/kg | 44.4 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 1.0 mg/kg | 59.3 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 25.0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 66.7
- group Id
- OG002
- value
- 42.9
- group Id
- OG003
- value
- 60.0
- group Id
- OG004
- value
- 40.0
- 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
- 33.3
- group Id
- OG003
- value
- 62.5
- group Id
- OG004
- value
- 100
- 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
- 66.7
- group Id
- OG002
- value
- 44.4
- group Id
- OG003
- value
- 59.3
- group Id
- OG004
- value
- 25.0
- 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
- The responder rate includes non-transfusion dependent efficacy (NTDE) participants and transfusion dependent efficacy (TDE) participants. For non-transfusion dependence efficacy (NTDE) participants who required \< 4 units of RBCs in the 8 weeks prior to start of therapy, HI-E was defined as an increase of \>=1.5 g/dL hemoglobin sustained for 56 days over a period of \>=8 weeks. For transfusion dependence efficacy (TDE) participants who required \>=4 units of RBCs in the 8 weeks prior to start of therapy, HI-E was defined as a decrease of \>= 4 units of RBCs transfused sustained for 56 days over a period of 8 weeks.
- 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
- NUMBER
- population Description
- Efficacy Evaluable Population: all participants who take at least one dose of study medication and have baseline and at least one post-baseline assessment of efficacy without major deviation from protocol.
- reporting Status
- POSTED
- time Frame
- Day 2 to Day 142
- title
- Percentage of Participants With Erythroid Hematological Improvement (HI-E) Starting Before the Completion of Five Cycles of Treatment (Responder Rate)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice