NCT01721772 · OUTCOME
Change From Baseline in Health-related Quality of Life (HRQoL) Scores Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma · Source last updated 2022-07-12
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 At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months What was measured HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.
Analysis population: All randomized participants with available measurements
Groups in this outcome Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
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 Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 210 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 208
Reported measurements Week 7 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 126 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 115
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1.39 19.46 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 2.32 20.52 Not reported Not reported Not reported
Week 13 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 95 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 59
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1.49 18.91 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 3.81 16.33 Not reported Not reported Not reported
Week 19 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 87 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 37
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3.07 16.58 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 3.15 17.16 Not reported Not reported Not reported
Week 25 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 71 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3.52 20.25 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab -0.76 21.28 Not reported Not reported Not reported
Week 31 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 66 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 20
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 2.53 20.46 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 4.17 17.83 Not reported Not reported Not reported
Week 37 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 64 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 14
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3.26 17.61 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 7.14 18.45 Not reported Not reported Not reported
Week 43 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 69 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 8
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1.69 20.24 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab -1.04 18.06 Not reported Not reported Not reported
Week 49 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 60 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 5
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 4.31 18.95 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 3.33 13.94 Not reported Not reported Not reported
Week 55 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 57 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 6
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 2.92 18.26 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 12.50 23.42 Not reported Not reported Not reported
Week 61 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 56 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 3
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1.79 18.72 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 13.89 17.35 Not reported Not reported Not reported
Week 67 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 56 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 2
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 2.08 21.92 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 8.33 11.79 Not reported Not reported Not reported
Week 73 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 48 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 2
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 4.69 17.10 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 12.50 5.89 Not reported Not reported Not reported
Week 79 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 46 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 2
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 5.62 18.84 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 8.33 11.79 Not reported Not reported Not reported
Week 85 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 41 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 2
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3.05 19.43 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 12.50 5.89 Not reported Not reported Not reported
Week 91 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 41 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 2
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3.66 20.92 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 16.67 0.00 Not reported Not reported Not reported
Week 97 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 39 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 2
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 4.27 19.48 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 8.33 11.79 Not reported Not reported Not reported
Week 103 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 39 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 6.20 19.56 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0.00 0.00 Not reported Not reported Not reported
Week 109 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 37 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 2
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3.83 20.75 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 8.33 11.79 Not reported Not reported Not reported
Week 115 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 34 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 4.17 21.15 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0.00 0.00 Not reported Not reported Not reported
Week 121 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 34 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1.47 20.25 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0.00 0.00 Not reported Not reported Not reported
Week 127 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 32 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine -0.26 19.91 Not reported Not reported Not reported
Week 133 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 29 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3.16 22.09 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 16.67 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 139 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 30 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1.11 21.86 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 16.67 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 145 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 32 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 4.69 20.07 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 16.67 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 151 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 30 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1.67 20.34 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 16.67 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 157 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 26 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3.53 22.99 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 163 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 21 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 7.94 20.83 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 16.67 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 169 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 20 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 13.33 17.61 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 175 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 17 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 7.84 23.66 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 50.00 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 181 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 20 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 5.42 21.16 Not reported Not reported Not reported
Week 187 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 18 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1.85 22.06 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 193 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 20 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 2.50 20.96 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 16.67 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 199 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 16 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 6.77 21.13 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 205 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 18 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 0.93 24.07 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 211 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 17 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 0.49 18.97 Not reported Not reported Not reported
Week 217 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 21 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1.19 23.32 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 223 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 19 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 5.26 25.49 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 229 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 21 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 5.56 23.77 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 16.67 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 235 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 17 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 5.39 24.82 Not reported Not reported Not reported
Week 241 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 18 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 2.78 25.72 Not reported Not reported Not reported
Week 247 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 14 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 5.36 25.45 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 16.67 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 253 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 15 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3.89 26.89 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 16.67 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 259 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 13 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 7.05 24.26 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 25.00 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 265 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 14 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 8.93 21.55 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 271 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 12 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 6.25 21.94 Not reported Not reported Not reported
Week 277 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 14 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 4.17 21.12 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 25.00 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 283 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 12 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 5.56 21.42 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 289 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 14 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3.57 20.86 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 295 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 12 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3.47 23.15 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 16.67 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 301 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 12 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 2.78 23.92 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 16.67 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 307 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 11 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1.52 24.95 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 313 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 10 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 9.17 24.04 Not reported Not reported Not reported
Week 319 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 10 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3.33 26.70 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 325 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 8 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 9.38 25.37 Not reported Not reported Not reported
Week 331 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 7 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 1
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 10.71 27.09 Not reported Not reported Not reported Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 33.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 337 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 7 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 11.90 26.29 Not reported Not reported Not reported
Week 343 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 6 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 16.67 26.35 Not reported Not reported Not reported
Week 349 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 7 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 9.52 26.54 Not reported Not reported Not reported
Week 355 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 5 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 0 10.21 Not reported Not reported Not reported
Week 361 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 4 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 20.83 30.81 Not reported Not reported Not reported
Week 367 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 25.00 36.32 Not reported Not reported Not reported
Week 373 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 3 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 25.00 36.32 Not reported Not reported Not reported
Week 379 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 8.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 385 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 8.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 391 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 8.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 397 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 8.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Week 403 Analysis denominator · Participants
Group Source count Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 1 Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab 0
Values in Units on a scale · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine 8.33 NA Not reported Not reported Insufficient number of participants to calculate standard deviation
Complete source fields classes categories measurements
group Id OG000
spread 19.46
value 1.39
group Id OG001
spread 20.52
value 2.32 denoms counts
group Id OG000
value 126
group Id OG001
value 115
units Participants
title Week 7 categories measurements
group Id OG000
spread 18.91
value 1.49
group Id OG001
spread 16.33
value 3.81 denoms counts
group Id OG000
value 95
group Id OG001
value 59
units Participants
title Week 13 categories measurements
group Id OG000
spread 16.58
value 3.07
group Id OG001
spread 17.16
value 3.15 denoms counts
group Id OG000
value 87
group Id OG001
value 37
units Participants
title Week 19 categories measurements
group Id OG000
spread 20.25
value 3.52
group Id OG001
spread 21.28
value -0.76 denoms counts
group Id OG000
value 71
group Id OG001
value 33
units Participants
title Week 25 categories measurements
group Id OG000
spread 20.46
value 2.53
group Id OG001
spread 17.83
value 4.17 denoms counts
group Id OG000
value 66
group Id OG001
value 20
units Participants
title Week 31 categories measurements
group Id OG000
spread 17.61
value 3.26
group Id OG001
spread 18.45
value 7.14 denoms counts
group Id OG000
value 64
group Id OG001
value 14
units Participants
title Week 37 categories measurements
group Id OG000
spread 20.24
value 1.69
group Id OG001
spread 18.06
value -1.04 denoms counts
group Id OG000
value 69
group Id OG001
value 8
units Participants
title Week 43 categories measurements
group Id OG000
spread 18.95
value 4.31
group Id OG001
spread 13.94
value 3.33 denoms counts
group Id OG000
value 60
group Id OG001
value 5
units Participants
title Week 49 categories measurements
group Id OG000
spread 18.26
value 2.92
group Id OG001
spread 23.42
value 12.50 denoms counts
group Id OG000
value 57
group Id OG001
value 6
units Participants
title Week 55 categories measurements
group Id OG000
spread 18.72
value 1.79
group Id OG001
spread 17.35
value 13.89 denoms counts
group Id OG000
value 56
group Id OG001
value 3
units Participants
title Week 61 categories measurements
group Id OG000
spread 21.92
value 2.08
group Id OG001
spread 11.79
value 8.33 denoms counts
group Id OG000
value 56
group Id OG001
value 2
units Participants
title Week 67 categories measurements
group Id OG000
spread 17.10
value 4.69
group Id OG001
spread 5.89
value 12.50 denoms counts
group Id OG000
value 48
group Id OG001
value 2
units Participants
title Week 73 Show more (12 of 67) denoms counts
group Id OG000
value 210
group Id OG001
value 208
units Participants
description HRQoL is evaluated by mean changes from baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) global health status/quality of life composite scale in all randomized patients. The QLQ-30 is a cancer-specific, self-administered questionnaire that contains 30 questions, covering global, functional, and symptom scales. Scores range from 0 to 100. Higher scores on global and functional scales indicate better quality of life (QoL), while higher scores on the symptom scales indicate declining QoL.
dispersion Type Standard Deviation groups
description Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
id OG000
title Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine
description Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
id OG001
title Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab
param Type MEAN
population Description All randomized participants with available measurements
reporting Status POSTED
time Frame At baseline and every 6 weeks for 12 months and at follow-up visits 1 and 2, assessed up to 93 months
title Change From Baseline in Health-related Quality of Life (HRQoL) Scores
type SECONDARY
unit Of Measure Units on a scale Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle