NCT00976911 · OUTCOME
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Ovarian (OV) 28 Abdominal/Gastrointestinal (AB/GI) Symptom Scale - Percentage of Responders (Data Cutoff 14 November 2011)
AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer · Source last updated 2022-06-21
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
- 95% Confidence Interval
- Time frame
- Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011)
What was measured
The EORTC OV-28 module is a questionnaire that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen/stomach? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms). Participants were considered a responder if they had a 10 point or more reduction in EORTC QLQ-OV28 AB/GI symptom scale score from baseline.
Analysis population: ITT population; n (number) = (equals) number of participants that completed the questionnaire at baseline and at the specified visit.
Groups in this outcome
Chemotherapy
Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
Chemotherapy + Bevacizumab
Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m\^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
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 |
|---|
| Chemotherapy | 84 |
|---|
| Chemotherapy + Bevacizumab | 122 |
|---|
Reported measurements
Weeks 8/9
Analysis denominator · Participants
| Group | Source count |
|---|
| Chemotherapy | 84 |
|---|
| Chemotherapy + Bevacizumab | 122 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemotherapy | 19.0 | Not reported | 11.3 | 29.1 | Not reported |
|---|
| Chemotherapy + Bevacizumab | 27.9 | Not reported | 20.1 | 36.7 | Not reported |
|---|
Weeks 16/18
Analysis denominator · Participants
| Group | Source count |
|---|
| Chemotherapy | 43 |
|---|
| Chemotherapy + Bevacizumab | 86 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemotherapy | 23.3 | Not reported | 11.8 | 38.6 | Not reported |
|---|
| Chemotherapy + Bevacizumab | 26.7 | Not reported | 17.8 | 37.4 | Not reported |
|---|
Week 24
Analysis denominator · Participants
| Group | Source count |
|---|
| Chemotherapy | 22 |
|---|
| Chemotherapy + Bevacizumab | 53 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemotherapy | 22.7 | Not reported | 7.8 | 45.4 | Not reported |
|---|
| Chemotherapy + Bevacizumab | 32.1 | Not reported | 19.9 | 46.3 | Not reported |
|---|
Week 30
Analysis denominator · Participants
| Group | Source count |
|---|
| Chemotherapy | 12 |
|---|
| Chemotherapy + Bevacizumab | 42 |
|---|
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Chemotherapy | 33.3 | Not reported | 9.9 | 65.1 | Not reported |
|---|
| Chemotherapy + Bevacizumab | 28.6 | Not reported | 15.7 | 44.6 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -3.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.4
- estimate Comment
- 95% CI was approximated with Hauck-Anderson continuity correction.
- group Description
- Comparison of responders at baseline versus Week 8/9
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.1859
- param Type
- Difference in Response Rates
- param Value
- 8.8
- statistical Method
- Fisher Exact
- ci Lower Limit
- -14
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 20.9
- estimate Comment
- 95% CI was approximated with Hauck-Anderson continuity correction.
- group Description
- Comparison of responders at baseline versus at Week 16/18
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.8309
- param Type
- Difference in Response Rates
- param Value
- 3.5
- statistical Method
- Fisher Exact
- ci Lower Limit
- -15
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 34.1
- estimate Comment
- 95% CI was approximated with Hauck-Anderson continuity correction.
- group Description
- Comparison of responders at baseline versus at Week 24
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.5790
- param Type
- Difference in Response Rates
- param Value
- 9.3
- statistical Method
- Fisher Exact
- ci Lower Limit
- -40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 30.6
- estimate Comment
- 95% CI was approximated with Hauck-Anderson continuity correction.
- group Description
- Comparison of responders at baseline versus at Week 30
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.7339
- param Type
- Difference in Response Rates
- param Value
- -4.8
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- ci Lower Limit
- -3.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 21.4
- estimate Comment
- 95% CI was approximated with Hauck-Anderson continuity correction.
- group Description
- Comparison of responders at baseline versus Week 8/9
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.1859
- param Type
- Difference in Response Rates
- param Value
- 8.8
- statistical Method
- Fisher Exact
- ci Lower Limit
- -14
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 20.9
- estimate Comment
- 95% CI was approximated with Hauck-Anderson continuity correction.
- group Description
- Comparison of responders at baseline versus at Week 16/18
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.8309
- param Type
- Difference in Response Rates
- param Value
- 3.5
- statistical Method
- Fisher Exact
- ci Lower Limit
- -15
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 34.1
- estimate Comment
- 95% CI was approximated with Hauck-Anderson continuity correction.
- group Description
- Comparison of responders at baseline versus at Week 24
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.5790
- param Type
- Difference in Response Rates
- param Value
- 9.3
- statistical Method
- Fisher Exact
- ci Lower Limit
- -40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 30.6
- estimate Comment
- 95% CI was approximated with Hauck-Anderson continuity correction.
- group Description
- Comparison of responders at baseline versus at Week 30
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.7339
- param Type
- Difference in Response Rates
- param Value
- -4.8
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.3
- upper Limit
- 29.1
- value
- 19.0
- group Id
- OG001
- lower Limit
- 20.1
- upper Limit
- 36.7
- value
- 27.9
- denoms
- counts
- group Id
- OG000
- value
- 84
- group Id
- OG001
- value
- 122
- units
- Participants
- title
- Weeks 8/9
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.8
- upper Limit
- 38.6
- value
- 23.3
- group Id
- OG001
- lower Limit
- 17.8
- upper Limit
- 37.4
- value
- 26.7
- denoms
- counts
- group Id
- OG000
- value
- 43
- group Id
- OG001
- value
- 86
- units
- Participants
- title
- Weeks 16/18
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.8
- upper Limit
- 45.4
- value
- 22.7
- group Id
- OG001
- lower Limit
- 19.9
- upper Limit
- 46.3
- value
- 32.1
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 53
- units
- Participants
- title
- Week 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.9
- upper Limit
- 65.1
- value
- 33.3
- group Id
- OG001
- lower Limit
- 15.7
- upper Limit
- 44.6
- value
- 28.6
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 42
- units
- Participants
- title
- Week 30
- denoms
- counts
- group Id
- OG000
- value
- 84
- group Id
- OG001
- value
- 122
- units
- Participants
- description
- The EORTC OV-28 module is a questionnaire that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen/stomach? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms). Participants were considered a responder if they had a 10 point or more reduction in EORTC QLQ-OV28 AB/GI symptom scale score from baseline.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
- id
- OG000
- title
- Chemotherapy
- description
- Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m\^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m\^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m\^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m\^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
- id
- OG001
- title
- Chemotherapy + Bevacizumab
- param Type
- NUMBER
- population Description
- ITT population; n (number) = (equals) number of participants that completed the questionnaire at baseline and at the specified visit.
- reporting Status
- POSTED
- time Frame
- Baseline and Weeks 8, 9, 16, 18, 24 and 30 (Data Cutoff 14 November 2011)
- title
- European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Ovarian (OV) 28 Abdominal/Gastrointestinal (AB/GI) Symptom Scale - Percentage of Responders (Data Cutoff 14 November 2011)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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