NCT02989857 · OUTCOME
Change From Baseline in HRQOL Based on: Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21)
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
For HRQOL based on QLQ-BIL21, subscales of eating symptoms and pain symptoms were assessed. Each item is a 4-point Likert scale. There are 4 response levels (not at all, a little, quite a bit, and very much). Raw scores are converted into scale scores ranging from 0 to 100. For symptom scales, lower scores=better QOL (negative change from Baseline=improvement).
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 | 70 |
|---|
| Placebo | 22 |
|---|
Reported measurements
Cycle 2 Day 1: Pain
Analysis denominator · Participants
| Group | Source count |
|---|
| AG-120 | 65 |
|---|
| Placebo | 20 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AG-120 | 5.1 | 1.94 | Not reported | Not reported | Not reported |
|---|
| Placebo | 10.1 | 3.49 | Not reported | Not reported | Not reported |
|---|
Cycle 2 Day 1: Appetite Loss
Analysis denominator · Participants
| Group | Source count |
|---|
| AG-120 | 65 |
|---|
| Placebo | 20 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AG-120 | 4.3 | 1.84 | Not reported | Not reported | Not reported |
|---|
| Placebo | 3.6 | 3.19 | Not reported | Not reported | Not reported |
|---|
Cycle 3 Day 1: Pain
Analysis denominator · Participants
| Group | Source count |
|---|
| AG-120 | 48 |
|---|
| Placebo | 9 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AG-120 | 2.3 | 2.16 | Not reported | Not reported | Not reported |
|---|
| Placebo | -2.1 | 4.70 | Not reported | Not reported | Not reported |
|---|
Cycle 3 Day 1: Appetite Loss
Analysis denominator · Participants
| Group | Source count |
|---|
| AG-120 | 48 |
|---|
| Placebo | 9 |
|---|
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| AG-120 | -2.0 | 2.02 | Not reported | Not reported | Not reported |
|---|
| Placebo | 4.1 | 4.24 | 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
- -12.93
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.80
- group Description
- Cycle 2 Day 1: Pain
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- -5.1
- ci Lower Limit
- -6.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.88
- group Description
- Cycle 2 Day 1: Appetite Loss
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- 0.7
- ci Lower Limit
- -5.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 14.55
- group Description
- Cycle 3 Day 1: Pain
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- 4.4
- ci Lower Limit
- -15.34
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.12
- group Description
- Cycle 3 Day 1: Appetite Loss
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- -6.1
Complete source fields
- analyses
- ci Lower Limit
- -12.93
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.80
- group Description
- Cycle 2 Day 1: Pain
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- -5.1
- ci Lower Limit
- -6.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.88
- group Description
- Cycle 2 Day 1: Appetite Loss
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- 0.7
- ci Lower Limit
- -5.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 14.55
- group Description
- Cycle 3 Day 1: Pain
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- 4.4
- ci Lower Limit
- -15.34
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.12
- group Description
- Cycle 3 Day 1: Appetite Loss
- non Inferiority Type
- OTHER
- param Type
- Least-squares mean difference
- param Value
- -6.1
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.94
- value
- 5.1
- group Id
- OG001
- spread
- 3.49
- value
- 10.1
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 20
- units
- Participants
- title
- Cycle 2 Day 1: Pain
- categories
- measurements
- group Id
- OG000
- spread
- 1.84
- value
- 4.3
- group Id
- OG001
- spread
- 3.19
- value
- 3.6
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 20
- units
- Participants
- title
- Cycle 2 Day 1: Appetite Loss
- categories
- measurements
- group Id
- OG000
- spread
- 2.16
- value
- 2.3
- group Id
- OG001
- spread
- 4.70
- value
- -2.1
- denoms
- counts
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Cycle 3 Day 1: Pain
- categories
- measurements
- group Id
- OG000
- spread
- 2.02
- value
- -2.0
- group Id
- OG001
- spread
- 4.24
- value
- 4.1
- denoms
- counts
- group Id
- OG000
- value
- 48
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Cycle 3 Day 1: Appetite Loss
- denoms
- counts
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 22
- units
- Participants
- description
- For HRQOL based on QLQ-BIL21, subscales of eating symptoms and pain symptoms were assessed. Each item is a 4-point Likert scale. There are 4 response levels (not at all, a little, quite a bit, and very much). Raw scores are converted into scale scores ranging from 0 to 100. For symptom scales, lower scores=better QOL (negative change from Baseline=improvement).
- 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 HRQOL Based on: Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21)
- type
- SECONDARY
- unit Of Measure
- score on a scale
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