TriangleNCT00769704 · OUTCOME
Response Interval
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 randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.
What was measured
Response interval is defined as the interval between the date of randomization and the date of the last documented evidence of response (CR or PR as assessed by the Investigator) prior to any new anti-cancer therapy. Response Interval post response onset was censored if a patient was still in response at the last observation.
Analysis population: Participants with an objective response (CR or PR) per Investigator assessment.
Groups in this outcome
GM-CSF
GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
Talimogene Laherparepvec
Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
| Group | Source count |
|---|---|
| GM-CSF | 9 |
| Talimogene Laherparepvec | 91 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| GM-CSF | 7.5 | Not reported | 1.9 | NA | Could not be estimated due to the low number of events |
| Talimogene Laherparepvec | NA | Not reported | NA | NA | Could not be estimated due to the low number of events |
Source statistical analyses
- ci Lower Limit
- 0.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.73
- estimate Comment
- The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer response interval for talimogene laherparepvec relative to GM-CSF.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0050
- p Value Comment
- Descriptive
- param Type
- Hazard Ratio (HR)
- param Value
- 0.30
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.13
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.73
- estimate Comment
- The hazard ratio was obtained from the unadjusted Cox Proportional Hazard Model. A hazard ratio \< 1.0 indicates a longer response interval for talimogene laherparepvec relative to GM-CSF.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0050
- p Value Comment
- Descriptive
- param Type
- Hazard Ratio (HR)
- param Value
- 0.30
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- comment
- Could not be estimated due to the low number of events
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- NA
- value
- 7.5
- comment
- Could not be estimated due to the low number of events
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 91
- units
- Participants
- description
- Response interval is defined as the interval between the date of randomization and the date of the last documented evidence of response (CR or PR as assessed by the Investigator) prior to any new anti-cancer therapy. Response Interval post response onset was censored if a patient was still in response at the last observation.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
- id
- OG000
- title
- GM-CSF
- description
- Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
- id
- OG001
- title
- Talimogene Laherparepvec
- param Type
- MEDIAN
- population Description
- Participants with an objective response (CR or PR) per Investigator assessment.
- reporting Status
- POSTED
- time Frame
- From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months.
- title
- Response Interval
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice