NCT03682536 · OUTCOME
The Number of Participants With Adverse Events (AEs)
A Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Participants Who Require Red Blood Cell Transfusions and Are ESA Naïve · Source last updated 2024-11-20
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
- From first dose to 42 days post last dose (Up to approximately an average of 72 weeks and a maximum of 208 weeks)
What was measured
Treatment-emergent adverse events include adverse events that started on or after the first dose of treatment until 42 days after the last dose of treatment, as well as those serious adverse events (SAEs) made known to the investigator at any time thereafter that are suspected of being related to treatment.
The severity/intensity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0). Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.
Analysis population: Safety Population - all participants who were randomized and received at least one dose of treatment.
Groups in this outcome
Luspatercept
Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.
Epoetin Alfa
Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).
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 |
|---|
| Luspatercept | 182 |
|---|
| Epoetin Alfa | 179 |
|---|
Reported measurements
One TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 178 | Not reported | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 165 | Not reported | Not reported | Not reported | Not reported |
|---|
One Suspected Related TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 61 | Not reported | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 36 | Not reported | Not reported | Not reported | Not reported |
|---|
One Serious TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 82 | Not reported | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 71 | Not reported | Not reported | Not reported | Not reported |
|---|
One Suspected Related Serious TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
NCI CTCAE Grade 3 or 4 TEAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 107 | Not reported | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 88 | Not reported | Not reported | Not reported | Not reported |
|---|
Suspected Related NCI CTCAE Grade 3 or 4 TEAEs
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
NCI CTCAE Grade 5 TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
Suspected Related NCI CTCAE Grade 5 TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
One TEAE Leading to Dose Interruption
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 61 | Not reported | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 51 | Not reported | Not reported | Not reported | Not reported |
|---|
One TEAE Leading to Dose Reduction
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
One TEAE Leading to Dose Withdrawn
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Epoetin Alfa | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 178
- group Id
- OG001
- value
- 165
- title
- One TEAE
- categories
- measurements
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 36
- title
- One Suspected Related TEAE
- categories
- measurements
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 71
- title
- One Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- title
- One Suspected Related Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 88
- title
- NCI CTCAE Grade 3 or 4 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 4
- title
- Suspected Related NCI CTCAE Grade 3 or 4 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 14
- title
- NCI CTCAE Grade 5 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Suspected Related NCI CTCAE Grade 5 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 51
- title
- One TEAE Leading to Dose Interruption
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 6
- title
- One TEAE Leading to Dose Reduction
- categories
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 13
- title
- One TEAE Leading to Dose Withdrawn
- denoms
- counts
- group Id
- OG000
- value
- 182
- group Id
- OG001
- value
- 179
- units
- Participants
- description
- Treatment-emergent adverse events include adverse events that started on or after the first dose of treatment until 42 days after the last dose of treatment, as well as those serious adverse events (SAEs) made known to the investigator at any time thereafter that are suspected of being related to treatment.
The severity/intensity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0). Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death.
- groups
- description
- Starting dose of 1.0 mg/kg subcutaneous injection every 3 weeks (21 days; Q3W). Dose levels can be increased in a stepwise manner beyond the starting dose to 1.33 mg/kg, and up to a maximum of 1.75 mg/kg.
- id
- OG000
- title
- Luspatercept
- description
- Starting dose of 450 IU/kg (maximum total starting dose is 40,000 IU) subcutaneous injection once every week (7 days; QW). Dose levels can be increased in a stepwise manner beyond the starting dose to 787.5 IU/kg, and up to a maximum of 1,050 IU/kg (with a maximum total dose of 80,000 IU).
- id
- OG001
- title
- Epoetin Alfa
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population - all participants who were randomized and received at least one dose of treatment.
- reporting Status
- POSTED
- time Frame
- From first dose to 42 days post last dose (Up to approximately an average of 72 weeks and a maximum of 208 weeks)
- title
- The Number of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
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