TriangleNCT00003702 · OUTCOME
Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay
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
- Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months.
What was measured
Primary outcome is measured as a difference in proportion responding between treatment arms and evaluated using a chi square test. A complete response was defined as a normal hCG sustained over four weekly measurements.
Analysis population: Eligible patients who received a random treatment allocation
Groups in this outcome
Arm 1: Methotrexate 30 mg/m2 IM Weekly
Arm 1: Methotrexate 30 mg/m2 IM weekly
Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
| Group | Source count |
|---|---|
| Arm 1: Methotrexate 30 mg/m2 IM Weekly | 107 |
| Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks | 109 |
Reported measurements
Complete/Cure
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Methotrexate 30 mg/m2 IM Weekly | 57 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks | 76 | Not reported | Not reported | Not reported | Not reported |
Non-response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Methotrexate 30 mg/m2 IM Weekly | 48 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks | 29 | Not reported | Not reported | Not reported | Not reported |
Inevaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm 1: Methotrexate 30 mg/m2 IM Weekly | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 76
- title
- Complete/Cure
- categories
- measurements
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 29
- title
- Non-response
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- title
- Inevaluable
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 109
- units
- Participants
- description
- Primary outcome is measured as a difference in proportion responding between treatment arms and evaluated using a chi square test. A complete response was defined as a normal hCG sustained over four weekly measurements.
- groups
- description
- Arm 1: Methotrexate 30 mg/m2 IM weekly
- id
- OG000
- title
- Arm 1: Methotrexate 30 mg/m2 IM Weekly
- description
- Arm 2: Dactinomycin 1.25 mg/m2 IV push every 2 weeks
- id
- OG001
- title
- Arm 2: Dactinomycin 1.25 mg/m2 IV Push Every 2 Weeks
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Eligible patients who received a random treatment allocation
- reporting Status
- POSTED
- time Frame
- Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months.
- title
- Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice