NCT01100502 · OUTCOME
Incidence of Adverse Events or Laboratory Abnormalities
A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial) · Source last updated 2021-05-14
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 12 months
Analysis population: Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis
Groups in this outcome
Brentuximab Vedotin
brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Placebo
placebo every 3 weeks by IV infusion
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 |
|---|
| Brentuximab Vedotin | 167 |
|---|
| Placebo | 160 |
|---|
Reported measurements
Any Treatment-Emergent Adverse Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin | 163 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 142 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Treatment-Related Adverse Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin | 147 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 79 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Adverse Event with Severity >= Grade 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin | 93 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 51 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Serious Adverse Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin | 41 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Treatment-Related Serious Adverse Events
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment Discontinuation Due to Adverse Event
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin | 54 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Any Laboratory Abnormalities Severity >=Grade 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Brentuximab Vedotin | 69 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 163
- group Id
- OG001
- value
- 142
- title
- Any Treatment-Emergent Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 147
- group Id
- OG001
- value
- 79
- title
- Any Treatment-Related Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 93
- group Id
- OG001
- value
- 51
- title
- Any Adverse Event with Severity >= Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 41
- group Id
- OG001
- value
- 20
- title
- Any Serious Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 7
- title
- Any Treatment-Related Serious Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 10
- title
- Treatment Discontinuation Due to Adverse Event
- categories
- measurements
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 29
- title
- Any Laboratory Abnormalities Severity >=Grade 3
- denoms
- counts
- group Id
- OG000
- value
- 167
- group Id
- OG001
- value
- 160
- units
- Participants
- groups
- description
- brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
- id
- OG000
- title
- Brentuximab Vedotin
- description
- placebo every 3 weeks by IV infusion
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- Safety Analysis Set includes all patients who received at least 1 dose of brentuximab vedotin or only received placebo: 2 patients randomized to placebo received a single dose of brentuximab vedotin and are included in the brentuximab vedotin arm; 2 patients randomized to placebo received no study treatment and are not included in the analysis
- reporting Status
- POSTED
- time Frame
- Up to 12 months
- title
- Incidence of Adverse Events or Laboratory Abnormalities
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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