NCT02500043 · OUTCOME
EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer · Source last updated 2024-09-03
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
- Not reported
- Time frame
- Baseline, Cycle 1 Day 1 up to end of treatment (EOT) (within 30 days of last study treatment) (maximum duration: up to approximately 46 months)
What was measured
The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) assessed symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, dietary restrictions, pain QS22, reflux, and anxiety) and 4 single items (dry mouth, hair loss, taste problems, body image). Most questions use 4-point scale (1='Not at all', 2=a little, 3=quite a bit and 4='Very much'). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100, where higher score=better level of functioning or greater degree of symptoms.
Analysis population: Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
Groups in this outcome
TAS-102+BSC
Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
Placebo+BSC
Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
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 |
|---|
| TAS-102+BSC | 337 |
|---|
| Placebo+BSC | 170 |
|---|
Reported measurements
Dysphagia
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TAS-102+BSC | 86.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+BSC | 78.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Dietary Restrictions
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TAS-102+BSC | 86.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+BSC | 78.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Pain QS22
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TAS-102+BSC | 86.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+BSC | 78.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Reflux
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TAS-102+BSC | 86.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+BSC | 78.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Anxiety
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TAS-102+BSC | 86.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+BSC | 78.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Dry Mouth
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TAS-102+BSC | 86.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+BSC | 78.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Body Image
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TAS-102+BSC | 85.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+BSC | 78.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Hair Loss
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TAS-102+BSC | 86.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+BSC | 78.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Taste Problems
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| TAS-102+BSC | 86.6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo+BSC | 78.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 86.6
- group Id
- OG001
- value
- 78.2
- title
- Dysphagia
- categories
- measurements
- group Id
- OG000
- value
- 86.6
- group Id
- OG001
- value
- 78.2
- title
- Dietary Restrictions
- categories
- measurements
- group Id
- OG000
- value
- 86.6
- group Id
- OG001
- value
- 78.2
- title
- Pain QS22
- categories
- measurements
- group Id
- OG000
- value
- 86.6
- group Id
- OG001
- value
- 78.2
- title
- Reflux
- categories
- measurements
- group Id
- OG000
- value
- 86.6
- group Id
- OG001
- value
- 78.2
- title
- Anxiety
- categories
- measurements
- group Id
- OG000
- value
- 86.4
- group Id
- OG001
- value
- 78.2
- title
- Dry Mouth
- categories
- measurements
- group Id
- OG000
- value
- 85.8
- group Id
- OG001
- value
- 78.2
- title
- Body Image
- categories
- measurements
- group Id
- OG000
- value
- 86.6
- group Id
- OG001
- value
- 78.2
- title
- Hair Loss
- categories
- measurements
- group Id
- OG000
- value
- 86.6
- group Id
- OG001
- value
- 78.2
- title
- Taste Problems
- denoms
- counts
- group Id
- OG000
- value
- 337
- group Id
- OG001
- value
- 170
- units
- Participants
- description
- The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) assessed symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, dietary restrictions, pain QS22, reflux, and anxiety) and 4 single items (dry mouth, hair loss, taste problems, body image). Most questions use 4-point scale (1='Not at all', 2=a little, 3=quite a bit and 4='Very much'). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100, where higher score=better level of functioning or greater degree of symptoms.
- groups
- description
- Participants received 35 mg/m\^2 of TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until a discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
- id
- OG000
- title
- TAS-102+BSC
- description
- Participants received 35 mg/m\^2 of matching placebo for TAS-102 tablets orally BID for 5 days per week (i.e., from Days 1 to 5 and Days 8 to 12) for 2 weeks followed by 14 days rest in each 28-day cycle along with BSC until discontinuation criterion (participant withdrawal, disease progression, irreversible treatment-related Grade 4 non-hematologic event, physician's decision, pregnancy or death) was met.
- id
- OG001
- title
- Placebo+BSC
- param Type
- NUMBER
- population Description
- Analysis was performed on the ITT population that included all randomized participants, regardless of whether or not study treatment was administered.
- reporting Status
- POSTED
- time Frame
- Baseline, Cycle 1 Day 1 up to end of treatment (EOT) (within 30 days of last study treatment) (maximum duration: up to approximately 46 months)
- title
- EORTC Quality of Life Questionnaire - Gastric-specific Module (EORTC QLQ-STO22): Percentage of Participants With Overall Compliance
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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