TriangleNCT01736683 · OUTCOME
Time to Erythroid Hematological Improvement (HI-E) Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Full Range
- Time frame
- Day 1 to Day 87
What was measured
Time to first response = start date of first response (HI-E) - first dose date + 1 day. For 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 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 of participants who responded
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 | 0 |
| Sotatercept 0.3 mg/kg | 4 |
| Sotatercept 0.5 mg/kg | 9 |
| Sotatercept 1.0 mg/kg | 21 |
| Sotatercept 2.0 mg/kg | 2 |
Reported measurements
All participants
| Group | Source count |
|---|---|
| Sotatercept 0.1 mg/kg | 0 |
| Sotatercept 0.3 mg/kg | 4 |
| Sotatercept 0.5 mg/kg | 9 |
| Sotatercept 1.0 mg/kg | 21 |
| Sotatercept 2.0 mg/kg | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sotatercept 0.3 mg/kg | 24.0 | Not reported | 2 | 44 | Not reported |
| Sotatercept 0.5 mg/kg | 1.0 | Not reported | 1 | 2 | Not reported |
| Sotatercept 1.0 mg/kg | 1.0 | Not reported | 1 | 86 | Not reported |
| Sotatercept 2.0 mg/kg | 48 | Not reported | 9 | 87 | Not reported |
NTDE subpopulation
| Group | Source count |
|---|---|
| Sotatercept 0.1 mg/kg | 0 |
| Sotatercept 0.3 mg/kg | 0 |
| Sotatercept 0.5 mg/kg | 1 |
| Sotatercept 1.0 mg/kg | 5 |
| Sotatercept 2.0 mg/kg | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sotatercept 0.5 mg/kg | 1.0 | Not reported | 1 | 1 | Not reported |
| Sotatercept 1.0 mg/kg | 1.0 | Not reported | 1 | 52 | Not reported |
| Sotatercept 2.0 mg/kg | 9.0 | Not reported | 9 | 9 | Not reported |
TDE subpopulation
| Group | Source count |
|---|---|
| Sotatercept 0.1 mg/kg | 0 |
| Sotatercept 0.3 mg/kg | 4 |
| Sotatercept 0.5 mg/kg | 8 |
| Sotatercept 1.0 mg/kg | 16 |
| Sotatercept 2.0 mg/kg | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sotatercept 0.3 mg/kg | 24.0 | Not reported | 2 | 44 | Not reported |
| Sotatercept 0.5 mg/kg | 1.5 | Not reported | 1 | 2 | Not reported |
| Sotatercept 1.0 mg/kg | 1.5 | Not reported | 1 | 86 | Not reported |
| Sotatercept 2.0 mg/kg | 87 | Not reported | 87 | 87 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 2
- upper Limit
- 44
- value
- 24.0
- group Id
- OG002
- lower Limit
- 1
- upper Limit
- 2
- value
- 1.0
- group Id
- OG003
- lower Limit
- 1
- upper Limit
- 86
- value
- 1.0
- group Id
- OG004
- lower Limit
- 9
- upper Limit
- 87
- value
- 48
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 2
- units
- Participants
- title
- All participants
- categories
- measurements
- group Id
- OG002
- lower Limit
- 1
- upper Limit
- 1
- value
- 1.0
- group Id
- OG003
- lower Limit
- 1
- upper Limit
- 52
- value
- 1.0
- group Id
- OG004
- lower Limit
- 9
- upper Limit
- 9
- value
- 9.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 1
- units
- Participants
- title
- NTDE subpopulation
- categories
- measurements
- group Id
- OG001
- lower Limit
- 2
- upper Limit
- 44
- value
- 24.0
- group Id
- OG002
- lower Limit
- 1
- upper Limit
- 2
- value
- 1.5
- group Id
- OG003
- lower Limit
- 1
- upper Limit
- 86
- value
- 1.5
- group Id
- OG004
- lower Limit
- 87
- upper Limit
- 87
- value
- 87
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 16
- group Id
- OG004
- value
- 1
- units
- Participants
- title
- TDE subpopulation
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 2
- units
- Participants
- description
- Time to first response = start date of first response (HI-E) - first dose date + 1 day. For 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 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.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- Efficacy Evaluable Population of participants who responded
- reporting Status
- POSTED
- time Frame
- Day 1 to Day 87
- title
- Time to Erythroid Hematological Improvement (HI-E) Response
- type
- SECONDARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice