NCT01736683 · OUTCOME
Participants With Treatment-Emergent Adverse Events (TEAE)
Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML) · Source last updated 2022-10-24
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 up to 59.2 months
What was measured
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 42 days after the last dose. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to the study drug and reported as 'Suspected' on the CRF. AEs with a missing relationship were treated as 'treatment-related' in data summaries.
Analysis population: Safety population: all participants who receive at least one dose of study medication.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · 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 |
|---|
Reported measurements
>= 1 Treatment-emergent adverse event (TEAE)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Sotatercept 0.1 mg/kg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 0.3 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 0.5 mg/kg | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 1.0 mg/kg | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 2.0 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
>=1 Treatment-related TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Sotatercept 0.1 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 0.3 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 0.5 mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 1.0 mg/kg | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 2.0 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
>=1 Serious TEAE
Values in Participants · Interval/dispersion: Not reported| 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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 0.5 mg/kg | 6 | 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 |
|---|
>=1 Serious TEAE related to treatment
Values in Participants · Interval/dispersion: Not reported| 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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
>=1 TEAE severity 3 or 4
Values in Participants · Interval/dispersion: Not reported| 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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 0.5 mg/kg | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 1.0 mg/kg | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 2.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
>=1 TEAE severity grade 3/4 related to treatment
Values in Participants · Interval/dispersion: Not reported| 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 | 1 | 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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
>=1 TEAE leading to death
Values in Participants · Interval/dispersion: Not reported| 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 | 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 |
|---|
>=1 TEAE leading to dose reduction
Values in Participants · Interval/dispersion: Not reported| 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 |
|---|
>=1 TEAE leading to dose interruption
Values in Participants · Interval/dispersion: Not reported| 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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
>=1 TEAE leading to dose interruption + reduction
Values in Participants · Interval/dispersion: Not reported| 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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 2.0 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
>= 1 TEAE leading to drug discontinuation
Values in Participants · Interval/dispersion: Not reported| 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 | 2 | 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 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Sotatercept 2.0 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 34
- group Id
- OG004
- value
- 5
- title
- >= 1 Treatment-emergent adverse event (TEAE)
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 18
- group Id
- OG004
- value
- 4
- title
- >=1 Treatment-related TEAE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 10
- group Id
- OG004
- value
- 2
- title
- >=1 Serious TEAE
- 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
- 1
- title
- >=1 Serious TEAE related to treatment
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 13
- group Id
- OG004
- value
- 2
- title
- >=1 TEAE severity 3 or 4
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- title
- >=1 TEAE severity grade 3/4 related to treatment
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- >=1 TEAE leading to death
- 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
- >=1 TEAE leading to dose reduction
- 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
- 1
- title
- >=1 TEAE leading to dose interruption
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- title
- >=1 TEAE leading to dose interruption + reduction
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- title
- >= 1 TEAE leading to drug discontinuation
- 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
- An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first treatment of the study medication and within 42 days after the last dose. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to the study drug and reported as 'Suspected' on the CRF. AEs with a missing relationship were treated as 'treatment-related' in data summaries.
- 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: all participants who receive at least one dose of study medication.
- reporting Status
- POSTED
- time Frame
- Day 1 up to 59.2 months
- title
- Participants With Treatment-Emergent Adverse Events (TEAE)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle