NCT02989857 · OUTCOME
Change From Baseline in Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 Subscales Scores
Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) · Source last updated 2024-08-20
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Cycle 2 Day 1 and Cycle 3 Day 1
What was measured
EORTC-QLQ-C30 is the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - Core Questionnaire. For EORTC QLQ-C30, subscales of physical functioning, pain, and appetite loss were assessed. These had 4 response levels (not at all, a little, quite a bit, and very much). For functional scales, higher scores=better QOL (positive change from Baseline=improvement). For symptom scales, lower scores=better QOL (negative change from Baseline=improvement). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100.
Analysis population: ITT population included all randomized participants, with treatment group designated according to the randomization. Overall Number of Participants Analyzed is the number of participants with data available for analyses at baseline and the given post-baseline timepoints. Number Analyzed at a particular timepoint is the number of participants with data available for analyses at baseline and given timepoint.
Groups in this outcome
AG-120
Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.
Placebo
Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| AG-120 | 73 |
|---|
| Placebo | 23 |
|---|
Reported measurements
Cycle 2 Day 1: Physical Functioning
Analysis denominator · Participants
| Group | Source count |
|---|
| AG-120 | 67 |
|---|
| Placebo | 21 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AG-120 | -2.4 | 1.75 | Not reported | Not reported | Not reported |
|---|
| Placebo | -13.3 | 2.95 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 1: Pain
Analysis denominator · Participants
| Group | Source count |
|---|
| AG-120 | 67 |
|---|
| Placebo | 21 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AG-120 | 2.2 | 2.48 | Not reported | Not reported | Not reported |
|---|
| Placebo | 12.5 | 4.35 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 1: Appetite Loss
Analysis denominator · Participants
| Group | Source count |
|---|
| AG-120 | 67 |
|---|
| Placebo | 21 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AG-120 | 7.9 | 2.60 | Not reported | Not reported | Not reported |
|---|
| Placebo | 4.3 | 4.55 | Not reported | Not reported | Not reported |
|---|
Cycle 3 Day 1: Physical Functioning
Analysis denominator · Participants
| Group | Source count |
|---|
| AG-120 | 50 |
|---|
| Placebo | 9 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AG-120 | -0.2 | 1.89 | Not reported | Not reported | Not reported |
|---|
| Placebo | -12.6 | 3.88 | Not reported | Not reported | Not reported |
|---|
Cycle 3 Day 1: Pain
Analysis denominator · Participants
| Group | Source count |
|---|
| AG-120 | 50 |
|---|
| Placebo | 9 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AG-120 | -1.2 | 2.73 | Not reported | Not reported | Not reported |
|---|
| Placebo | -5.3 | 5.96 | Not reported | Not reported | Not reported |
|---|
Cycle 3 Day 1: Appetite Loss
Analysis denominator · Participants
| Group | Source count |
|---|
| AG-120 | 50 |
|---|
| Placebo | 9 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AG-120 | -0.5 | 2.89 | Not reported | Not reported | Not reported |
|---|
| Placebo | 3.2 | 6.40 | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- 4.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.73
- group Description
- Cycle 2 Day 1: Physical Functioning
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- 11.0
- ci Lower Limit
- -20.18
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.52
- group Description
- Cycle 2 Day 1: Pain
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- -10.4
- ci Lower Limit
- -6.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.91
- group Description
- Cycle 2 Day 1: Appetite Loss
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- 3.6
- ci Lower Limit
- 3.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 20.78
- group Description
- Cycle 3 Day 1: Physical Functioning
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- 12.3
- ci Lower Limit
- -8.74
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.04
- group Description
- Cycle 3 Day 1: Pain
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- 4.1
- ci Lower Limit
- -17.46
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.11
- group Description
- Cycle 3 Day 1: Appetite Loss
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- -3.7
Complete source fields
- analyses
- ci Lower Limit
- 4.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.73
- group Description
- Cycle 2 Day 1: Physical Functioning
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- 11.0
- ci Lower Limit
- -20.18
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.52
- group Description
- Cycle 2 Day 1: Pain
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- -10.4
- ci Lower Limit
- -6.65
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 13.91
- group Description
- Cycle 2 Day 1: Appetite Loss
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- 3.6
- ci Lower Limit
- 3.85
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 20.78
- group Description
- Cycle 3 Day 1: Physical Functioning
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- 12.3
- ci Lower Limit
- -8.74
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 17.04
- group Description
- Cycle 3 Day 1: Pain
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- 4.1
- ci Lower Limit
- -17.46
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 10.11
- group Description
- Cycle 3 Day 1: Appetite Loss
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- -3.7
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.75
- value
- -2.4
- group Id
- OG001
- spread
- 2.95
- value
- -13.3
- denoms
- counts
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 21
- units
- Participants
- title
- Cycle 2 Day 1: Physical Functioning
- categories
- measurements
- group Id
- OG000
- spread
- 2.48
- value
- 2.2
- group Id
- OG001
- spread
- 4.35
- value
- 12.5
- denoms
- counts
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 21
- units
- Participants
- title
- Cycle 2 Day 1: Pain
- categories
- measurements
- group Id
- OG000
- spread
- 2.60
- value
- 7.9
- group Id
- OG001
- spread
- 4.55
- value
- 4.3
- denoms
- counts
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 21
- units
- Participants
- title
- Cycle 2 Day 1: Appetite Loss
- categories
- measurements
- group Id
- OG000
- spread
- 1.89
- value
- -0.2
- group Id
- OG001
- spread
- 3.88
- value
- -12.6
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Cycle 3 Day 1: Physical Functioning
- categories
- measurements
- group Id
- OG000
- spread
- 2.73
- value
- -1.2
- group Id
- OG001
- spread
- 5.96
- value
- -5.3
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Cycle 3 Day 1: Pain
- categories
- measurements
- group Id
- OG000
- spread
- 2.89
- value
- -0.5
- group Id
- OG001
- spread
- 6.40
- value
- 3.2
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Cycle 3 Day 1: Appetite Loss
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 23
- units
- Participants
- description
- EORTC-QLQ-C30 is the European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - Core Questionnaire. For EORTC QLQ-C30, subscales of physical functioning, pain, and appetite loss were assessed. These had 4 response levels (not at all, a little, quite a bit, and very much). For functional scales, higher scores=better QOL (positive change from Baseline=improvement). For symptom scales, lower scores=better QOL (negative change from Baseline=improvement). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100.
- dispersion Type
- Standard Error
- groups
- description
- Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.
- id
- OG000
- title
- AG-120
- description
- Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
- id
- OG001
- title
- Placebo
- param Type
- LEAST_SQUARES_MEAN
- population Description
- ITT population included all randomized participants, with treatment group designated according to the randomization. Overall Number of Participants Analyzed is the number of participants with data available for analyses at baseline and the given post-baseline timepoints. Number Analyzed at a particular timepoint is the number of participants with data available for analyses at baseline and given timepoint.
- reporting Status
- POSTED
- time Frame
- Cycle 2 Day 1 and Cycle 3 Day 1
- title
- Change From Baseline in Health-Related Quality of Life (HRQOL) Based on European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 Subscales Scores
- type
- SECONDARY
- unit Of Measure
- score on a scale
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