TriangleNCT00068250 · OUTCOME
Phase II: Overall Survival Rate at 2 Years (Including Phase I Patients at Same Dose)
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
- Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.
What was measured
Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (Please note that this outcome measure is considered the primary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
Analysis population: Eligible patients on Temozolomide 100 mg arms who started study treatment
Groups in this outcome
Combined Temozolomide 100mg Arms
Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
| Group | Source count |
|---|---|
| Combined Temozolomide 100mg Arms | 53 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combined Temozolomide 100mg Arms | 80.8 | Not reported | 70.1 | 91.5 | Not reported |
Source statistical analyses
- group Description
- Null hypothesis: Two-year survival rate \<= 64%; Alternative hypothesis: Two-year survival rate \> 64%. The fixed survival rate for comparison comes from Radiation Therapy Oncology Group (RTOG) trial 9310. (RTOG 9310 does not fall within ClinicalTrials.gov registration/reporting requirements.)
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.006
- statistical Method
- One-sample z-test
Complete source fields
- analyses
- group Description
- Null hypothesis: Two-year survival rate \<= 64%; Alternative hypothesis: Two-year survival rate \> 64%. The fixed survival rate for comparison comes from Radiation Therapy Oncology Group (RTOG) trial 9310. (RTOG 9310 does not fall within ClinicalTrials.gov registration/reporting requirements.)
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.006
- statistical Method
- One-sample z-test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 70.1
- upper Limit
- 91.5
- value
- 80.8
- denoms
- counts
- group Id
- OG000
- value
- 53
- units
- Participants
- description
- Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. (Please note that this outcome measure is considered the primary endpoint for the Phase II component of the study, but that the patients from Phase I that were treated at the same dose level are included, as indicated in the treatment arm descriptions. )
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Phase I: Temozolomide 100mg and Phase II: Temozolomide 100 mg
- id
- OG000
- title
- Combined Temozolomide 100mg Arms
- param Type
- NUMBER
- population Description
- Eligible patients on Temozolomide 100 mg arms who started study treatment
- reporting Status
- POSTED
- time Frame
- Analysis occured after all patients have been on study for 2 years. Maximum follow-up at time of analysis was 8.5 years.
- title
- Phase II: Overall Survival Rate at 2 Years (Including Phase I Patients at Same Dose)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice