TriangleNCT00626990 · OUTCOME
Overall Survival as Measured From the Day of Randomization
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study)
What was measured
The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination.
Analysis population: This trial studied 2 questions 1) effect of concomitant Temozolomide (TMZ) 2) effect of adjuvant TMZ. The 4 randomized arms were combined. Absence of concomitant TMZ including Arm Radiotherapy (RT) alone \& Arm RT followed by adjuvant TMZ. Presence of concomitant TMZ including Arm TMZ/RT \& Arm TMZ/RT followed by adjuvant TMZ. Absence of adjuvant TMZ including Arm RT alone \& Arm TMZ/RT. Presence of adjuvant TMZ including Arm RT followed by adjuvant TMZ \& Arm TMZ/RT followed by adjuvant TMZ
Groups in this outcome
Absence of Concomitant Temozolomide (TMZ)
Including 2 randomized arms: Arm RT alone and Arm RT followed by adjuvant TMZ
Presence of Concomitant Temozolomide (TMZ)
Including 2 randomized arms: Arm TMZ/RT and Arm TMZ/RT followed by adjuvant TMZ
Absence of Adjuvant Temozolomide (TMZ)
Including two randomized arms: Arm RT alone and Arm TMZ/RT
Presence of Adjuvant Temozolomide (TMZ)
Including to 2 randomized arms: Arm RT followed by adjuvant TMZ and Arm TMZ/RT followed by adjuvant TMZ
| Group | Source count |
|---|---|
| Absence of Concomitant Temozolomide (TMZ) | 375 |
| Presence of Concomitant Temozolomide (TMZ) | 376 |
| Absence of Adjuvant Temozolomide (TMZ) | 377 |
| Presence of Adjuvant Temozolomide (TMZ) | 374 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Absence of Concomitant Temozolomide (TMZ) | 60.42 | Not reported | 45.7 | 71.49 | Not reported |
| Presence of Concomitant Temozolomide (TMZ) | 66.92 | Not reported | 48.53 | 82.33 | Not reported |
| Absence of Adjuvant Temozolomide (TMZ) | 46.92 | Not reported | 37.88 | 56.94 | Not reported |
| Presence of Adjuvant Temozolomide (TMZ) | 82.33 | Not reported | 67.19 | 116.63 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.73
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.1
- ci Upper Limit
- 1.28
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.76
- param Type
- Hazard Ratio (HR)
- param Value
- 0.97
- statistical Method
- Regression, Cox
- ci Lower Limit
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.79
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.64
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.73
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 99.1
- ci Upper Limit
- 1.28
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.76
- param Type
- Hazard Ratio (HR)
- param Value
- 0.97
- statistical Method
- Regression, Cox
- ci Lower Limit
- 0.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.79
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.64
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 45.7
- upper Limit
- 71.49
- value
- 60.42
- group Id
- OG001
- lower Limit
- 48.53
- upper Limit
- 82.33
- value
- 66.92
- group Id
- OG002
- lower Limit
- 37.88
- upper Limit
- 56.94
- value
- 46.92
- group Id
- OG003
- lower Limit
- 67.19
- upper Limit
- 116.63
- value
- 82.33
- denoms
- counts
- group Id
- OG000
- value
- 375
- group Id
- OG001
- value
- 376
- group Id
- OG002
- value
- 377
- group Id
- OG003
- value
- 374
- units
- Participants
- description
- The duration of survival is the time interval between randomization and the date of death due to any cause. Patients not reported dead or lost to follow up will be censored at the date of the last follow up examination.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Including 2 randomized arms: Arm RT alone and Arm RT followed by adjuvant TMZ
- id
- OG000
- title
- Absence of Concomitant Temozolomide (TMZ)
- description
- Including 2 randomized arms: Arm TMZ/RT and Arm TMZ/RT followed by adjuvant TMZ
- id
- OG001
- title
- Presence of Concomitant Temozolomide (TMZ)
- description
- Including two randomized arms: Arm RT alone and Arm TMZ/RT
- id
- OG002
- title
- Absence of Adjuvant Temozolomide (TMZ)
- description
- Including to 2 randomized arms: Arm RT followed by adjuvant TMZ and Arm TMZ/RT followed by adjuvant TMZ
- id
- OG003
- title
- Presence of Adjuvant Temozolomide (TMZ)
- param Type
- MEDIAN
- population Description
- This trial studied 2 questions 1) effect of concomitant Temozolomide (TMZ) 2) effect of adjuvant TMZ. The 4 randomized arms were combined. Absence of concomitant TMZ including Arm Radiotherapy (RT) alone \& Arm RT followed by adjuvant TMZ. Presence of concomitant TMZ including Arm TMZ/RT \& Arm TMZ/RT followed by adjuvant TMZ. Absence of adjuvant TMZ including Arm RT alone \& Arm TMZ/RT. Presence of adjuvant TMZ including Arm RT followed by adjuvant TMZ \& Arm TMZ/RT followed by adjuvant TMZ
- reporting Status
- POSTED
- time Frame
- from date from enrollment till the date of death (time till death is up to 10.9 years after patient enrollment in the study)
- title
- Overall Survival as Measured From the Day of Randomization
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice