NCT02631070 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
A Study of Luspatercept (ACE-536) to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes · Source last updated 2021-12-17
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 date of first dose up to 42 days after the last dose (up to approximately 83 weeks)
What was measured
The outcome measure describes the number of participants who experienced different types of Treatment-emergent adverse events (TEAEs).
TEAEs were defined as Adverse Events (AEs) that started on or after the day of the first dose and on or before 42 days after the last dose of IP.
The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.
Analysis population: All treated participants
Groups in this outcome
Luspatercept
Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
Placebo
Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
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 | 153 |
|---|
| Placebo | 76 |
|---|
Reported measurements
≥ 1 TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 151 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 70 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Suspected Related TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 71 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Serious TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 66 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Suspected Related Serious TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 TEAE CTCAE Toxicity Grade (GR) 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Suspected Related TEAE With CTCAE GR 5
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 TEAE with CTCAE GR 3 or 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 86 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 Suspected Related TEAE With CTCAE GR 3 or 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 3 | 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 |
|---|
| Luspatercept | 42 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 4 | 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 |
|---|
| Luspatercept | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
≥ 1 TEAE Leading to Study Drug Discontinuation
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Luspatercept | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 151
- group Id
- OG001
- value
- 70
- title
- ≥ 1 TEAE
- categories
- measurements
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 26
- title
- ≥ 1 Suspected Related TEAE
- categories
- measurements
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 23
- title
- ≥ 1 Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 0
- title
- ≥ 1 Suspected Related Serious TEAE
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 4
- title
- ≥ 1 TEAE CTCAE Toxicity Grade (GR) 5
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- ≥ 1 Suspected Related TEAE With CTCAE GR 5
- categories
- measurements
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 34
- title
- ≥ 1 TEAE with CTCAE GR 3 or 4
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 3
- title
- ≥ 1 Suspected Related TEAE With CTCAE GR 3 or 4
- categories
- measurements
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 4
- title
- ≥ 1 TEAE Leading to Dose Interruption
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 0
- title
- ≥ 1 TEAE Leading to Dose Reduction
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 6
- title
- ≥ 1 TEAE Leading to Study Drug Discontinuation
- denoms
- counts
- group Id
- OG000
- value
- 153
- group Id
- OG001
- value
- 76
- units
- Participants
- description
- The outcome measure describes the number of participants who experienced different types of Treatment-emergent adverse events (TEAEs).
TEAEs were defined as Adverse Events (AEs) that started on or after the day of the first dose and on or before 42 days after the last dose of IP.
The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death.
- groups
- description
- Luspatercept 1.0 mg/Kg SC on Day 1 of each 21-day treatment cycle
- id
- OG000
- title
- Luspatercept
- description
- Placebo (Volume equivalent to experimental arm) SC on Day 1 of each 21-day treatment cycle
- id
- OG001
- title
- Placebo
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated participants
- reporting Status
- POSTED
- time Frame
- From date of first dose up to 42 days after the last dose (up to approximately 83 weeks)
- title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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