TriangleNCT01736683 · OUTCOME
Dose Limiting Toxicities (DLTs)
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 1 to 59.2 months
What was measured
The following were DLTs if the investigator suspected they were treatment related: 1. Increase to \>= 140 mmHg systolic blood pressure 2. Increase to \>=90 mmHg diastolic blood pressure 3. Increase to \>=140 systolic and increase \> 20 mmHg compared to baseline systolic 4. Increase to \>=90 mmHg diastolic and increase \> 20 mmHg compared to baseline diastolic 5. Introduction of new anti-hypertension medication during treatment 6. Increase in dose of baseline anti-hypertension medication during treatment 7. \>= Grade 2 (moderate severity or worse) hypertension as an adverse event
Analysis population: Safety 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
1. Increase to >= 140 mmHg systolic
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sotatercept 0.1 mg/kg | 1 | 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 | 8 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 1.0 mg/kg | 19 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
2. Increase to >=90 mmHg diastolic
| 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 | 0 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
3. =140 systolic and increase > 20 mmHg base
| 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 | 5 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 1.0 mg/kg | 10 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
4. >=90 mmHg diastolic and increase > 20 mmHg base
| 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 | 0 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
5. Introduction of new anti-hypertension med
| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 0.5 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 1.0 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
6. Incre in dose of baseline anti-hypertension med
| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 0.5 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 1.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
7.>= Grade 2 hypertension TEAE
| 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 | 4 | Not reported | Not reported | Not reported | Not reported |
| Sotatercept 2.0 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 19
- group Id
- OG004
- value
- 2
- title
- 1. Increase to >= 140 mmHg systolic
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- title
- 2. Increase to >=90 mmHg diastolic
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 2
- title
- 3. =140 systolic and increase > 20 mmHg base
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- title
- 4. >=90 mmHg diastolic and increase > 20 mmHg base
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- title
- 5. Introduction of new anti-hypertension med
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- 6. Incre in dose of baseline anti-hypertension med
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 1
- title
- 7.>= Grade 2 hypertension TEAE
- 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 following were DLTs if the investigator suspected they were treatment related: 1. Increase to \>= 140 mmHg systolic blood pressure 2. Increase to \>=90 mmHg diastolic blood pressure 3. Increase to \>=140 systolic and increase \> 20 mmHg compared to baseline systolic 4. Increase to \>=90 mmHg diastolic and increase \> 20 mmHg compared to baseline diastolic 5. Introduction of new anti-hypertension medication during treatment 6. Increase in dose of baseline anti-hypertension medication during treatment 7. \>= Grade 2 (moderate severity or worse) hypertension as an adverse event
- 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
- Safety population
- reporting Status
- POSTED
- time Frame
- Day 1 to 59.2 months
- title
- Dose Limiting Toxicities (DLTs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice