NCT01777152 · OUTCOME
Incidence of Adverse Events (AEs)
ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas · Source last updated 2021-11-30
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
- Up to 8.28 months
What was measured
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
Analysis population: The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment.
Groups in this outcome
A+CHP
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
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 |
|---|
| A+CHP | 223 |
|---|
| CHOP | 226 |
|---|
Reported measurements
Any treatment-emergent AE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| A+CHP | 221 | Not reported | Not reported | Not reported | Not reported |
|---|
| CHOP | 221 | Not reported | Not reported | Not reported | Not reported |
|---|
Blinded study treatment-related AE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| A+CHP | 201 | Not reported | Not reported | Not reported | Not reported |
|---|
| CHOP | 193 | Not reported | Not reported | Not reported | Not reported |
|---|
CHP treatment-related AE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| A+CHP | 198 | Not reported | Not reported | Not reported | Not reported |
|---|
| CHOP | 205 | Not reported | Not reported | Not reported | Not reported |
|---|
Any serious adverse event (SAE)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| A+CHP | 87 | Not reported | Not reported | Not reported | Not reported |
|---|
| CHOP | 87 | Not reported | Not reported | Not reported | Not reported |
|---|
Blinded study treatment-related SAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| A+CHP | 58 | Not reported | Not reported | Not reported | Not reported |
|---|
| CHOP | 45 | Not reported | Not reported | Not reported | Not reported |
|---|
CHP treatment-related SAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| A+CHP | 62 | Not reported | Not reported | Not reported | Not reported |
|---|
| CHOP | 53 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment discontinuations due to AE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| A+CHP | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| CHOP | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment discontinuations due to blinded study treatment-related AE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| A+CHP | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| CHOP | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment discontinuations due to CHP treatment-related AE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| A+CHP | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| CHOP | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 221
- group Id
- OG001
- value
- 221
- title
- Any treatment-emergent AE
- categories
- measurements
- group Id
- OG000
- value
- 201
- group Id
- OG001
- value
- 193
- title
- Blinded study treatment-related AE
- categories
- measurements
- group Id
- OG000
- value
- 198
- group Id
- OG001
- value
- 205
- title
- CHP treatment-related AE
- categories
- measurements
- group Id
- OG000
- value
- 87
- group Id
- OG001
- value
- 87
- title
- Any serious adverse event (SAE)
- categories
- measurements
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 45
- title
- Blinded study treatment-related SAE
- categories
- measurements
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 53
- title
- CHP treatment-related SAE
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 15
- title
- Treatment discontinuations due to AE
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- title
- Treatment discontinuations due to blinded study treatment-related AE
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 7
- title
- Treatment discontinuations due to CHP treatment-related AE
- denoms
- counts
- group Id
- OG000
- value
- 223
- group Id
- OG001
- value
- 226
- units
- Participants
- description
- Any untoward medical occurrence in a clinical investigational participant administered a medicinal product which does not necessarily have a causal relationship with this treatment.
- groups
- description
- brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone brentuximab vedotin: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
- id
- OG000
- title
- A+CHP
- description
- cyclophosphamide, doxorubicin, vincristine, and prednisone doxorubicin: 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles prednisone: 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles vincristine: 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles cyclophosphamide: 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
- id
- OG001
- title
- CHOP
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Safety Analysis Set includes all patients who receive any amount of brentuximab vedotin or any component of CHOP. Treatment group will be determined using the actual treatment received, regardless of the randomization treatment assignment.
- reporting Status
- POSTED
- time Frame
- Up to 8.28 months
- title
- Incidence of Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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