TriangleNCT00952289 · OUTCOME
Overall Survival - Extended Data
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From randomization to 4 months after the data cut-off date (up to 18 months).
What was measured
Overall survival is reported here by the number of deaths from randomization 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
Death events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 13 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 24 | Not reported | Not reported | Not reported | Not reported |
Censored events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 142 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 130 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 24
- title
- Death events
- categories
- measurements
- group Id
- OG000
- value
- 142
- group Id
- OG001
- value
- 130
- title
- Censored events
- denoms
- counts
- group Id
- OG000
- value
- 155
- group Id
- OG001
- value
- 154
- units
- Participants
- description
- Overall survival is reported here by the number of deaths from randomization 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.
- 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
- NUMBER
- 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 - Extended Data
- type
- SECONDARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice