TriangleNCT01920932 · OUTCOME
Complete Response Rate Estimate for All Evaluable Participants
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)
What was measured
To evaluate the safety of AEPA/CAPDac, as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high-risk patients with Hodgkin Lymphoma (HL).
Analysis population: All the evaluable participants that completed the first 2 cycles of chemotherapy.
Groups in this outcome
AEPA/CAPDac
Ann Arbor stage IIB, IIIB, IVA, or IVB participants receive: 2 cycles of AEPA chemotherapy: (A) Brentuximab vedotin 1.2 mg/kg IV (intravenous) days 1, 8 and 15, (E) Etoposide 125 mg/m\^2 IV days 1-5, (P) Prednisone 60 mg/m\^2/day PO (orally) days 1-15, (A) Doxorubicin 40 mg/m\^2 IV days 1 and 15), Followed by 4 cycles of CAPDac: (C) Cyclophosphamide 500 mg/m\^2 IV days 1 and 8, (A) Brentuximab vedotin 1.2 mg/kg IV days 1 and 8, (P) Prednisone 40 mg/m\^2/day PO days 1-15, (Dac) Dacarbazine 250 mg/m\^2 IV days 1-3.). Filgrastim 5 mcg/kg subcutaneous (SC) as clinically indicated. For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy is given.
| Group | Source count |
|---|---|
| AEPA/CAPDac | 77 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AEPA/CAPDac | 35 | Not reported | 24 | 46 | Not reported |
Source statistical analyses
- group Description
- Comparison of proportion of patient's complete response rate between HLHR13 and HOD99 (NCT00145600) unfavorable risk arm 2 (UR2).
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.004
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- group Description
- Comparison of proportion of patient's complete response rate between HLHR13 and HOD99 (NCT00145600) unfavorable risk arm 2 (UR2).
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.004
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24
- upper Limit
- 46
- value
- 35
- denoms
- counts
- group Id
- OG000
- value
- 77
- units
- Participants
- description
- To evaluate the safety of AEPA/CAPDac, as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high-risk patients with Hodgkin Lymphoma (HL).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ann Arbor stage IIB, IIIB, IVA, or IVB participants receive: 2 cycles of AEPA chemotherapy: (A) Brentuximab vedotin 1.2 mg/kg IV (intravenous) days 1, 8 and 15, (E) Etoposide 125 mg/m\^2 IV days 1-5, (P) Prednisone 60 mg/m\^2/day PO (orally) days 1-15, (A) Doxorubicin 40 mg/m\^2 IV days 1 and 15), Followed by 4 cycles of CAPDac: (C) Cyclophosphamide 500 mg/m\^2 IV days 1 and 8, (A) Brentuximab vedotin 1.2 mg/kg IV days 1 and 8, (P) Prednisone 40 mg/m\^2/day PO days 1-15, (Dac) Dacarbazine 250 mg/m\^2 IV days 1-3.). Filgrastim 5 mcg/kg subcutaneous (SC) as clinically indicated. For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy is given.
- id
- OG000
- title
- AEPA/CAPDac
- param Type
- NUMBER
- population Description
- All the evaluable participants that completed the first 2 cycles of chemotherapy.
- reporting Status
- POSTED
- time Frame
- After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)
- title
- Complete Response Rate Estimate for All Evaluable Participants
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice