TriangleNCT00952289 · OUTCOME
Overall Survival Time - Extended Data
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to 4 months after the data cut-off date (up to 18 months).
What was measured
Overall survival was assessed by the time to death or censoring up until 01 March 2011. Patients were censored at this time or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. This outcome reports data from August 2009 through March 2011 to coincide with a pre-planned New Drug Application (NDA) 120-day safety update.
Analysis population: ITT population
Groups in this outcome
Ruxolitinib
Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
Placebo
Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
| Group | Source count |
|---|---|
| Ruxolitinib | 155 |
| Placebo | 154 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | NA | Not reported | NA | NA | The median overall survival was not reached as more than 50% of patients were still living at the time of the database cut-off using the Kaplan-Meier method. |
| Placebo | NA | Not reported | NA | NA | The median overall survival was not reached as more than 50% of patients were still living at the time of the database cut-off using the Kaplan-Meier method. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median overall survival was not reached as more than 50% of patients were still living at the time of the database cut-off using the Kaplan-Meier method.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The median overall survival was not reached as more than 50% of patients were still living at the time of the database cut-off using the Kaplan-Meier method.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 155
- group Id
- OG001
- value
- 154
- units
- Participants
- description
- Overall survival was assessed by the time to death or censoring up until 01 March 2011. Patients were censored at this time or the later of either the date of withdrawal or the date of last follow-up for patients who withdrew from study before the date of data cut. The survival time was analyzed using the Kaplan-Meier method. This outcome reports data from August 2009 through March 2011 to coincide with a pre-planned New Drug Application (NDA) 120-day safety update.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
- id
- OG000
- title
- Ruxolitinib
- description
- Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- ITT population
- reporting Status
- POSTED
- time Frame
- From randomization to 4 months after the data cut-off date (up to 18 months).
- title
- Overall Survival Time - Extended Data
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice