TriangleNCT01013649 · OUTCOME
Overall Survival (Percentage of Participants Alive) by Baseline Fatigue Group
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- From enrollment (step 1) to death or last follow-up. Maximum follow-up at time of the phase III analysis was 13.2 years, measured from enrollment. Two- and five-year rates are reported here.
What was measured
Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from enrollment (step 1) to date of death from any cause or last known follow-up (censored). Baseline fatigue is measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACT-F) questionnaire which has a range of 0 to 52 with a higher score indicating less fatigue. Combining treatment arms, patients with low fatigue at baseline (FACIT-F score \> 30) will be compared to patients with high fatigue at baseline (FACIT-F scores ≤ 30).
Analysis population: Eligible participants enrolled at step 1 who consented to the quality of life study component and have baseline FACT-F data.
Groups in this outcome
High Fatigue
Participants from both treatment arms with FACIT-F score ≤ 30.
Low Fatigue
Participants from both treatment arms with FACIT-F score \> 30.
| Group | Source count |
|---|---|
| High Fatigue | 71 |
| Low Fatigue | 352 |
Reported measurements
Two years
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| High Fatigue | 54.1 | Not reported | 44.3 | 64.0 | Not reported |
| Low Fatigue | 58.1 | Not reported | 53.7 | 62.6 | Not reported |
Five years
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| High Fatigue | 21.1 | Not reported | 13.0 | 29.5 | Not reported |
| Low Fatigue | 25.1 | Not reported | 21.1 | 29.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.13
- estimate Comment
- Reference level = High Fatigue group
- group Description
- Four hundred evaluable patients provide at least 90% power to detect a HR of 0.70 between low and high fatigue groups using a baseline FACIT-F score cut point of 30, with a 1-sided alpha of 0.05.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.21
- p Value Comment
- One-sided significance level = 0.05
- param Type
- Hazard Ratio (HR)
- param Value
- 0.89
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.13
- estimate Comment
- Reference level = High Fatigue group
- group Description
- Four hundred evaluable patients provide at least 90% power to detect a HR of 0.70 between low and high fatigue groups using a baseline FACIT-F score cut point of 30, with a 1-sided alpha of 0.05.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.21
- p Value Comment
- One-sided significance level = 0.05
- param Type
- Hazard Ratio (HR)
- param Value
- 0.89
- statistical Method
- Log Rank
- anticipated Posting Date
- 2025-12
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 44.3
- upper Limit
- 64.0
- value
- 54.1
- group Id
- OG001
- lower Limit
- 53.7
- upper Limit
- 62.6
- value
- 58.1
- title
- Two years
- categories
- measurements
- group Id
- OG000
- lower Limit
- 13.0
- upper Limit
- 29.5
- value
- 21.1
- group Id
- OG001
- lower Limit
- 21.1
- upper Limit
- 29.1
- value
- 25.1
- title
- Five years
- denoms
- counts
- group Id
- OG000
- value
- 71
- group Id
- OG001
- value
- 352
- units
- Participants
- description
- Overall survival is estimated by the Kaplan-Meier method. Survival time is measured from enrollment (step 1) to date of death from any cause or last known follow-up (censored). Baseline fatigue is measured by Functional Assessment of Chronic Illness Therapy-Fatigue (FACT-F) questionnaire which has a range of 0 to 52 with a higher score indicating less fatigue. Combining treatment arms, patients with low fatigue at baseline (FACIT-F score \> 30) will be compared to patients with high fatigue at baseline (FACIT-F scores ≤ 30).
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants from both treatment arms with FACIT-F score ≤ 30.
- id
- OG000
- title
- High Fatigue
- description
- Participants from both treatment arms with FACIT-F score \> 30.
- id
- OG001
- title
- Low Fatigue
- param Type
- NUMBER
- population Description
- Eligible participants enrolled at step 1 who consented to the quality of life study component and have baseline FACT-F data.
- reporting Status
- POSTED
- time Frame
- From enrollment (step 1) to death or last follow-up. Maximum follow-up at time of the phase III analysis was 13.2 years, measured from enrollment. Two- and five-year rates are reported here.
- title
- Overall Survival (Percentage of Participants Alive) by Baseline Fatigue Group
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice