TriangleNCT01736683 · OUTCOME
Duration of Erythroid Hematological Improvement (HI-E)
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 183.7 weeks
What was measured
The duration of HI-E response for participants who responded was (the last date of the consecutive hemoglobin \[Hgb\] measurements of the first \>=56 day interval) - (the first date of the consecutive Hgb measurements of the first \>=56 day interval) + 1 day.
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 | 62.5 | Not reported | 62 | 69 | Not reported |
| Sotatercept 0.5 mg/kg | 104.0 | Not reported | 56 | 1794 | Not reported |
| Sotatercept 1.0 mg/kg | 133.0 | Not reported | 58 | 1554 | Not reported |
| Sotatercept 2.0 mg/kg | 96.0 | Not reported | 58 | 134 | 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 | 6 |
| Sotatercept 2.0 mg/kg | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sotatercept 0.5 mg/kg | 79.0 | Not reported | 79 | 79 | Not reported |
| Sotatercept 1.0 mg/kg | 1043.0 | Not reported | 69 | 1554 | Not reported |
| Sotatercept 2.0 mg/kg | 134.0 | Not reported | 134 | 134 | 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 | 62.5 | Not reported | 62 | 69 | Not reported |
| Sotatercept 0.5 mg/kg | 105.5 | Not reported | 56 | 1794 | Not reported |
| Sotatercept 1.0 mg/kg | 96.5 | Not reported | 58 | 1033 | Not reported |
| Sotatercept 2.0 mg/kg | 58.0 | Not reported | 58 | 58 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- lower Limit
- 62
- upper Limit
- 69
- value
- 62.5
- group Id
- OG002
- lower Limit
- 56
- upper Limit
- 1794
- value
- 104.0
- group Id
- OG003
- lower Limit
- 58
- upper Limit
- 1554
- value
- 133.0
- group Id
- OG004
- lower Limit
- 58
- upper Limit
- 134
- value
- 96.0
- 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
- 79
- upper Limit
- 79
- value
- 79.0
- group Id
- OG003
- lower Limit
- 69
- upper Limit
- 1554
- value
- 1043.0
- group Id
- OG004
- lower Limit
- 134
- upper Limit
- 134
- value
- 134.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 1
- units
- Participants
- title
- NTDE subpopulation
- categories
- measurements
- group Id
- OG001
- lower Limit
- 62
- upper Limit
- 69
- value
- 62.5
- group Id
- OG002
- lower Limit
- 56
- upper Limit
- 1794
- value
- 105.5
- group Id
- OG003
- lower Limit
- 58
- upper Limit
- 1033
- value
- 96.5
- group Id
- OG004
- lower Limit
- 58
- upper Limit
- 58
- value
- 58.0
- 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
- The duration of HI-E response for participants who responded was (the last date of the consecutive hemoglobin \[Hgb\] measurements of the first \>=56 day interval) - (the first date of the consecutive Hgb measurements of the first \>=56 day interval) + 1 day.
- 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 183.7 weeks
- title
- Duration of Erythroid Hematological Improvement (HI-E)
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice