TriangleNCT01920932 · OUTCOME
Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2).
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)
What was measured
Event-free survival (EFS) is defined as the probability of survival between the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Under the proportional hazard model assumption, the two-sample log-rank test used to compare the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2).
Analysis population: For HLHR13, all the evaluable participants that treated with AEPA/CAPDac; for HOD99 Unfavorable Risk 2 Arm (UR2), all the evaluable participants that treated with Stanford V + RT.
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 | 0.974 | Not reported | 0.951 | 0.997 | Not reported |
Source statistical analyses
- group Description
- The comparison of the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2) was done by the two-sample log-rank test.
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0008
- statistical Method
- Log Rank
Complete source fields
- analyses
- group Description
- The comparison of the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2) was done by the two-sample log-rank test.
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0008
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.951
- upper Limit
- 0.997
- value
- 0.974
- denoms
- counts
- group Id
- OG000
- value
- 77
- units
- Participants
- description
- Event-free survival (EFS) is defined as the probability of survival between the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Under the proportional hazard model assumption, the two-sample log-rank test used to compare the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2).
- 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
- For HLHR13, all the evaluable participants that treated with AEPA/CAPDac; for HOD99 Unfavorable Risk 2 Arm (UR2), all the evaluable participants that treated with Stanford V + RT.
- reporting Status
- POSTED
- time Frame
- From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)
- title
- Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2).
- type
- PRIMARY
- unit Of Measure
- probability
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice