NCT00636168 · OUTCOME
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint
Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma · Source last updated 2019-12-17
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline up to 2 years from randomization
What was measured
Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scales linearly transformed to 0-100 scales. Higher scores for Global Health Status indicate better HRQoL. An increase from baseline indicates improvement in HRQoL compared to baseline. HRQoL was administered within 1 week prior to first dose (baseline) and on Days 22, 43, 64 (+/- 3 days), Week 24 and every 12 weeks up to 2 years, independent of disease progression.
Analysis population: All randomized participants (ITT) analyzed in the arm to which they were allocated by randomization were analyzed. At timepoint level, all randomized participants (ITT) with a measurement at the timepoint were analyzed.
Groups in this outcome
Ipilimumab 10mg/kg
Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
Placebo
Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
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 |
|---|
| Ipilimumab 10mg/kg | 400 |
|---|
| Placebo | 421 |
|---|
Reported measurements
Week 4 Day 22
Analysis denominator · Participants
| Group | Source count |
|---|
| Ipilimumab 10mg/kg | 400 |
|---|
| Placebo | 421 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ipilimumab 10mg/kg | -2.29 | 15.96 | Not reported | Not reported | Not reported |
|---|
| Placebo | 1.33 | 14.02 | Not reported | Not reported | Not reported |
|---|
Week 7, Day 43
Analysis denominator · Participants
| Group | Source count |
|---|
| Ipilimumab 10mg/kg | 360 |
|---|
| Placebo | 412 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ipilimumab 10mg/kg | -6.64 | 20.44 | Not reported | Not reported | Not reported |
|---|
| Placebo | -0.10 | 16.75 | Not reported | Not reported | Not reported |
|---|
Week 10 Day 64
Analysis denominator · Participants
| Group | Source count |
|---|
| Ipilimumab 10mg/kg | 356 |
|---|
| Placebo | 405 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ipilimumab 10mg/kg | -9.06 | 23.56 | Not reported | Not reported | Not reported |
|---|
| Placebo | -0.23 | 16.18 | Not reported | Not reported | Not reported |
|---|
Week 24 Day 162 (300, 347)
Analysis denominator · Participants
| Group | Source count |
|---|
| Ipilimumab 10mg/kg | 300 |
|---|
| Placebo | 347 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ipilimumab 10mg/kg | -4.33 | 21.55 | Not reported | Not reported | Not reported |
|---|
| Placebo | 1.37 | 17.00 | Not reported | Not reported | Not reported |
|---|
Week 36 Day 246
Analysis denominator · Participants
| Group | Source count |
|---|
| Ipilimumab 10mg/kg | 290 |
|---|
| Placebo | 307 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ipilimumab 10mg/kg | -5.09 | 21.32 | Not reported | Not reported | Not reported |
|---|
| Placebo | 1.52 | 18.52 | Not reported | Not reported | Not reported |
|---|
Week 48 Day 330
Analysis denominator · Participants
| Group | Source count |
|---|
| Ipilimumab 10mg/kg | 275 |
|---|
| Placebo | 276 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ipilimumab 10mg/kg | -3.67 | 20.17 | Not reported | Not reported | Not reported |
|---|
| Placebo | 1.54 | 18.87 | Not reported | Not reported | Not reported |
|---|
Week 60 Day 414
Analysis denominator · Participants
| Group | Source count |
|---|
| Ipilimumab 10mg/kg | 242 |
|---|
| Placebo | 255 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ipilimumab 10mg/kg | -5.30 | 21.34 | Not reported | Not reported | Not reported |
|---|
| Placebo | 2.84 | 17.05 | Not reported | Not reported | Not reported |
|---|
Week 72 day 498
Analysis denominator · Participants
| Group | Source count |
|---|
| Ipilimumab 10mg/kg | 217 |
|---|
| Placebo | 248 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ipilimumab 10mg/kg | -4.07 | 23.19 | Not reported | Not reported | Not reported |
|---|
| Placebo | 1.18 | 17.46 | Not reported | Not reported | Not reported |
|---|
Week 84 Day 582
Analysis denominator · Participants
| Group | Source count |
|---|
| Ipilimumab 10mg/kg | 205 |
|---|
| Placebo | 227 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ipilimumab 10mg/kg | -3.90 | 22.06 | Not reported | Not reported | Not reported |
|---|
| Placebo | 1.84 | 17.08 | Not reported | Not reported | Not reported |
|---|
Week 96 Day 666
Analysis denominator · Participants
| Group | Source count |
|---|
| Ipilimumab 10mg/kg | 199 |
|---|
| Placebo | 214 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ipilimumab 10mg/kg | -4.48 | 21.71 | Not reported | Not reported | Not reported |
|---|
| Placebo | 1.36 | 18.67 | Not reported | Not reported | Not reported |
|---|
Week 108 Day 750
Analysis denominator · Participants
| Group | Source count |
|---|
| Ipilimumab 10mg/kg | 162 |
|---|
| Placebo | 177 |
|---|
Values in units on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ipilimumab 10mg/kg | -4.27 | 20.35 | Not reported | Not reported | Not reported |
|---|
| Placebo | 2.45 | 16.72 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 15.96
- value
- -2.29
- group Id
- OG001
- spread
- 14.02
- value
- 1.33
- denoms
- counts
- group Id
- OG000
- value
- 400
- group Id
- OG001
- value
- 421
- units
- Participants
- title
- Week 4 Day 22
- categories
- measurements
- group Id
- OG000
- spread
- 20.44
- value
- -6.64
- group Id
- OG001
- spread
- 16.75
- value
- -0.10
- denoms
- counts
- group Id
- OG000
- value
- 360
- group Id
- OG001
- value
- 412
- units
- Participants
- title
- Week 7, Day 43
- categories
- measurements
- group Id
- OG000
- spread
- 23.56
- value
- -9.06
- group Id
- OG001
- spread
- 16.18
- value
- -0.23
- denoms
- counts
- group Id
- OG000
- value
- 356
- group Id
- OG001
- value
- 405
- units
- Participants
- title
- Week 10 Day 64
- categories
- measurements
- group Id
- OG000
- spread
- 21.55
- value
- -4.33
- group Id
- OG001
- spread
- 17.00
- value
- 1.37
- denoms
- counts
- group Id
- OG000
- value
- 300
- group Id
- OG001
- value
- 347
- units
- Participants
- title
- Week 24 Day 162 (300, 347)
- categories
- measurements
- group Id
- OG000
- spread
- 21.32
- value
- -5.09
- group Id
- OG001
- spread
- 18.52
- value
- 1.52
- denoms
- counts
- group Id
- OG000
- value
- 290
- group Id
- OG001
- value
- 307
- units
- Participants
- title
- Week 36 Day 246
- categories
- measurements
- group Id
- OG000
- spread
- 20.17
- value
- -3.67
- group Id
- OG001
- spread
- 18.87
- value
- 1.54
- denoms
- counts
- group Id
- OG000
- value
- 275
- group Id
- OG001
- value
- 276
- units
- Participants
- title
- Week 48 Day 330
- categories
- measurements
- group Id
- OG000
- spread
- 21.34
- value
- -5.30
- group Id
- OG001
- spread
- 17.05
- value
- 2.84
- denoms
- counts
- group Id
- OG000
- value
- 242
- group Id
- OG001
- value
- 255
- units
- Participants
- title
- Week 60 Day 414
- categories
- measurements
- group Id
- OG000
- spread
- 23.19
- value
- -4.07
- group Id
- OG001
- spread
- 17.46
- value
- 1.18
- denoms
- counts
- group Id
- OG000
- value
- 217
- group Id
- OG001
- value
- 248
- units
- Participants
- title
- Week 72 day 498
- categories
- measurements
- group Id
- OG000
- spread
- 22.06
- value
- -3.90
- group Id
- OG001
- spread
- 17.08
- value
- 1.84
- denoms
- counts
- group Id
- OG000
- value
- 205
- group Id
- OG001
- value
- 227
- units
- Participants
- title
- Week 84 Day 582
- categories
- measurements
- group Id
- OG000
- spread
- 21.71
- value
- -4.48
- group Id
- OG001
- spread
- 18.67
- value
- 1.36
- denoms
- counts
- group Id
- OG000
- value
- 199
- group Id
- OG001
- value
- 214
- units
- Participants
- title
- Week 96 Day 666
- categories
- measurements
- group Id
- OG000
- spread
- 20.35
- value
- -4.27
- group Id
- OG001
- spread
- 16.72
- value
- 2.45
- denoms
- counts
- group Id
- OG000
- value
- 162
- group Id
- OG001
- value
- 177
- units
- Participants
- title
- Week 108 Day 750
- denoms
- counts
- group Id
- OG000
- value
- 400
- group Id
- OG001
- value
- 421
- units
- Participants
- description
- Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scales linearly transformed to 0-100 scales. Higher scores for Global Health Status indicate better HRQoL. An increase from baseline indicates improvement in HRQoL compared to baseline. HRQoL was administered within 1 week prior to first dose (baseline) and on Days 22, 43, 64 (+/- 3 days), Week 24 and every 12 weeks up to 2 years, independent of disease progression.
- dispersion Type
- Standard Deviation
- groups
- description
- Ipilimumab (10 mg/kg) as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (every 21 days in the Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, Ipilimumab was administered at a dose of 10 mg/kg, by IV infusion, every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
- id
- OG000
- title
- Ipilimumab 10mg/kg
- description
- Placebo as a single dose via a 90 minute intravenous (IV) infusion (not as bolus or IV push) during Days 1, 22, 43 and 64 (Induction Phase) for a total of four separate doses, until disease recurrence, unacceptable toxicity or withdrawal of consent. During the maintenance phase, placebo was administered by IV infusion every 12 weeks, beginning at Week 24, until disease recurrence, unacceptable toxicity or withdrawal of consent, for a maximum of 3 years (Week 156).
- id
- OG001
- title
- Placebo
- param Type
- MEAN
- population Description
- All randomized participants (ITT) analyzed in the arm to which they were allocated by randomization were analyzed. At timepoint level, all randomized participants (ITT) with a measurement at the timepoint were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline up to 2 years from randomization
- title
- Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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