TriangleNCT00122460 · OUTCOME
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- scores on a scale
- Interval / dispersion
- Standard Error
- Time frame
- at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007
What was measured
Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of social functioning.
Analysis population: Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab +chemotherapy/chemotherapy alone): Baseline:123/109; Cycle3:87/69; Month6:48/23
Groups in this outcome
Cetuximab Plus Chemotherapy
Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
Chemotherapy Alone
All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
| Group | Source count |
|---|---|
| Cetuximab Plus Chemotherapy | 152 |
| Chemotherapy Alone | 139 |
Reported measurements
At baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cetuximab Plus Chemotherapy | 62.14 | 4.459 | Not reported | Not reported | Not reported |
| Chemotherapy Alone | 62.05 | 4.730 | Not reported | Not reported | Not reported |
At cycle 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cetuximab Plus Chemotherapy | 64.64 | 4.663 | Not reported | Not reported | Not reported |
| Chemotherapy Alone | 60.67 | 5.176 | Not reported | Not reported | Not reported |
Month 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cetuximab Plus Chemotherapy | 61.27 | 5.347 | Not reported | Not reported | Not reported |
| Chemotherapy Alone | 65.72 | 7.122 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 4.459
- value
- 62.14
- group Id
- OG001
- spread
- 4.730
- value
- 62.05
- title
- At baseline
- categories
- measurements
- group Id
- OG000
- spread
- 4.663
- value
- 64.64
- group Id
- OG001
- spread
- 5.176
- value
- 60.67
- title
- At cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 5.347
- value
- 61.27
- group Id
- OG001
- spread
- 7.122
- value
- 65.72
- title
- Month 6
- denoms
- counts
- group Id
- OG000
- value
- 152
- group Id
- OG001
- value
- 139
- units
- Participants
- description
- Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of social functioning.
- dispersion Type
- Standard Error
- groups
- description
- Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
- id
- OG000
- title
- Cetuximab Plus Chemotherapy
- description
- All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
- id
- OG001
- title
- Chemotherapy Alone
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Of 361 ITT subjects from countries with EORTC QLQ-C30 available, 291 completed ≥1 evaluable questionnaire. Only time points where ≥ 20% of patients completing a baseline questionnaire remained in the population were analysed. Numbers at each timepoint were (cetuximab +chemotherapy/chemotherapy alone): Baseline:123/109; Cycle3:87/69; Month6:48/23
- reporting Status
- POSTED
- time Frame
- at baseline, day 1 of cycle 3, first 6-weekly evaluation following completion of chemotherapy, 6 & 12 months after randomization, reported between day of first patient randomised, 21 Dec 2004,until cut-off date, 12 Mar 2007
- title
- Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
- type
- SECONDARY
- unit Of Measure
- scores on a scale
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Preserved source evidence · Not medical advice