TriangleNCT01566695 · OUTCOME
Overall Survival (OS)
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 up to death from any cause; up to a maximum of approximately 10 years on study; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
What was measured
Overall survival was defined as the time from randomization to death from any cause and was calculated using randomization date and date of death, or date of last follow-up for censored participants. All subjects were followed until drop out (withdrawal of consent from further data collection or lost to follow-up), death, or study closure. Participants who dropped out or were alive at study closure (or at the time of the interim analysis) had their OS times censored at the time of last contact, as appropriate.
Analysis population: Intent to Treat population
Groups in this outcome
Oral Azacitidine and Best Supportive Care
Participants received 300 mg oral azacitidine tablets daily on days 1 to 21 of each 28-day treatment cycle and BSC included and was not limited to pRBC (packed red blood cell \[pRBC\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
Placebo Plus Best Supportive Care
Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.
| Group | Source count |
|---|---|
| Oral Azacitidine and Best Supportive Care | 107 |
| Placebo Plus Best Supportive Care | 109 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Azacitidine and Best Supportive Care | 17.3 | Not reported | 12.9 | 20.8 | Not reported |
| Placebo Plus Best Supportive Care | 16.7 | Not reported | 12.8 | 24.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.49
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- other Analysis Description
- Cox proportional hazards model with stratifies factors
- p Value
- 0.6257
- param Type
- Hazard Ratio (HR)
- param Value
- 1.08
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.79
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.49
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- other Analysis Description
- Cox proportional hazards model with stratifies factors
- p Value
- 0.6257
- param Type
- Hazard Ratio (HR)
- param Value
- 1.08
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.9
- upper Limit
- 20.8
- value
- 17.3
- group Id
- OG001
- lower Limit
- 12.8
- upper Limit
- 24.0
- value
- 16.7
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 109
- units
- Participants
- description
- Overall survival was defined as the time from randomization to death from any cause and was calculated using randomization date and date of death, or date of last follow-up for censored participants. All subjects were followed until drop out (withdrawal of consent from further data collection or lost to follow-up), death, or study closure. Participants who dropped out or were alive at study closure (or at the time of the interim analysis) had their OS times censored at the time of last contact, as appropriate.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 300 mg oral azacitidine tablets daily on days 1 to 21 of each 28-day treatment cycle and BSC included and was not limited to pRBC (packed red blood cell \[pRBC\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
- id
- OG000
- title
- Oral Azacitidine and Best Supportive Care
- description
- Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.
- id
- OG001
- title
- Placebo Plus Best Supportive Care
- param Type
- MEDIAN
- population Description
- Intent to Treat population
- reporting Status
- POSTED
- time Frame
- From randomization up to death from any cause; up to a maximum of approximately 10 years on study; median duration of treatment to oral azacitidine was 5.29 months and 5.36 months for placebo
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice