TriangleNCT00091572 · OUTCOME
Objective Response Rate in Subjects With Measurable Lesions
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Ratio
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Treatment continued until disease progression or unacceptable toxicity.
What was measured
Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.
Analysis population: Intent to treat population with measurable disease at Baseline.
Groups in this outcome
Temozolomide
temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
Dacarbazine
dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
| Group | Source count |
|---|---|
| Temozolomide | 401 |
| Dacarbazine | 388 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Temozolomide | 0.14 | Not reported | 0.10 | 0.17 | Not reported |
| Dacarbazine | 0.10 | Not reported | 0.07 | 0.12 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.97
- ci Pct Value
- 95
- ci Upper Limit
- 2.12
- estimate Comment
- Temozolomide numerator (responders) = 55. Dacarbazine numerator (responders) = 37.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0718
- param Type
- Odds Ratio (OR)
- param Value
- 1.43
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 0.97
- ci Pct Value
- 95
- ci Upper Limit
- 2.12
- estimate Comment
- Temozolomide numerator (responders) = 55. Dacarbazine numerator (responders) = 37.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0718
- param Type
- Odds Ratio (OR)
- param Value
- 1.43
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.10
- upper Limit
- 0.17
- value
- 0.14
- group Id
- OG001
- lower Limit
- 0.07
- upper Limit
- 0.12
- value
- 0.10
- denoms
- counts
- group Id
- OG000
- value
- 401
- group Id
- OG001
- value
- 388
- units
- Participants
- description
- Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days ("7 days on / 7 days off" continuously)
- id
- OG000
- title
- Temozolomide
- description
- dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
- id
- OG001
- title
- Dacarbazine
- param Type
- MEDIAN
- population Description
- Intent to treat population with measurable disease at Baseline.
- reporting Status
- POSTED
- time Frame
- Treatment continued until disease progression or unacceptable toxicity.
- title
- Objective Response Rate in Subjects With Measurable Lesions
- type
- SECONDARY
- unit Of Measure
- Ratio
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice