Table 2.
Patient-reported outcome completion rates.a
| Patients, n/N (%) | Nivolumab (n = 316) | Nivolumab + ipilimumab (n = 314) | Ipilimumab (n = 315) |
|---|---|---|---|
| EORTC QLQ-C30 | |||
| Baselineb | 284/316 (89.9) | 290/314 (92.4) | 279/315 (88.6) |
| Baseline plus ≥1 | 269/316 (85.1) | 274/314 (87.3) | 259/315 (82.2) |
| Week 5 | 228/302 (75.5) | 182/293 (62.1) | 220/300 (73.3) |
| Week 7 | 237/291 (81.4) | 182/276 (65.9) | 217/291 (74.6) |
| Week 11 | 198/271 (73.1) | 113/226 (50.0) | 163/244 (66.8) |
| Week 13 | 193/249 (77.5) | 106/201 (52.7) | 129/205 (62.9) |
| Week 17 | 156/220 (70.9) | 83/164 (50.6) | 103/158 (65.2) |
| Week 19 | 164/205 (80.0) | 97/155 (62.6) | 98/144 (68.1) |
| Week 23 | 133/188 (70.7) | 87/137 (63.5) | 76/118 (64.4) |
| Week 25 | 142/182 (78.0) | 97/130 (74.6) | 74/111 (66.7) |
| Week 31 | 121/164 (73.8) | 92/125 (73.6) | 50/87 (57.5) |
| Week 37 | 112/152 (73.7) | 90/119 (75.6) | 48/75 (64.0) |
| Week 43 | 100/145 (69.0) | 74/114 (64.9) | 44/65 (67.7) |
| Week 49 | 92/128 (71.9) | 65/97 (67.0) | 40/58 (69.0) |
| Week 55 | 63/100 (63.0) | 48/72 (66.7) | 24/43 (55.8) |
| Week 61 | 38/58 (65.5) | 29/42 (69.0) | 17/28 (60.7) |
| Week 67 | 13/21 (61.9) | 16/22 (72.7) | 9/13 (69.2) |
| Week 73 | 3/4 (75.0) | 6/9 (66.7) | 0/2 (0) |
| Week 79 | – | 2/2 (100.0) | 1/2 (50.0) |
| Follow-up 1c | 96/104 (92.3) | 105/108 (97.2) | 124/136 (91.2) |
| Follow-up 2c | 58/62 (93.5) | 96/99 (97.0) | 97/103 (94.2) |
| EQ-5D | |||
| Baselineb | 282/316 (89.2) | 290/314 (92.4) | 278/315 (88.3) |
| Baseline plus ≥1 | 267/316 (84.5) | 274/314 (87.3) | 258/315 (81.9) |
| Week 5 | 227/302 (75.2) | 180/293 (61.4) | 218/300 (72.7) |
| Week 7 | 237/291 (81.4) | 182/276 (65.9) | 216/291 (74.2) |
| Week 11 | 198/271 (73.1) | 113/226 (50.0) | 163/244 (66.8) |
| Week 13 | 193/249 (77.5) | 106/201 (52.7) | 129/205 (62.9) |
| Week 17 | 156/220 (70.9) | 83/164 (50.6) | 103/158 (65.2) |
| Week 19 | 163/205 (79.5) | 97/155 (62.6) | 97/144 (67.4) |
| Week 23 | 133/188 (70.7) | 87/137 (63.5) | 76/118 (64.4) |
| Week 25 | 142/182 (78.0) | 97/130 (74.6) | 74/111 (66.7) |
| Week 31 | 121/164 (73.8) | 92/125 (73.6) | 50/87 (57.5) |
| Week 37 | 112/152 (73.7) | 89/119 (74.8) | 48/75 (64.0) |
| Week 43 | 100/145 (69.0) | 74/114 (64.9) | 44/65 (67.7) |
| Week 49 | 92/128 (71.9) | 65/97 (67.0) | 40/58 (69.0) |
| Week 55 | 63/100 (63.0) | 48/72 (66.7) | 24/43 (55.8) |
| Week 61 | 38/58 (65.5) | 29/42 (69.0) | 17/28 (60.7) |
| Week 67 | 13/21 (61.9) | 16/22 (72.7) | 9/13 (69.2) |
| Week 73 | 3/4 (75.0) | 6/9 (66.7) | 0/2 (0) |
| Week 79 | – | 2/2 (100.0) | 1/2 (50.0) |
| Follow-up 1c | 96/104 (92.3) | 105/108 (97.2) | 124/136 (91.2) |
| Follow-up 2c | 58/62 (93.5) | 96/99 (97.0) | 97/103 (94.2) |
a
Completion rate is calculated using the number of patients with non-missing PRO data at baseline and data from ≥ 1 post-baseline visit, divided by the number of patients in the study at each respective time point.
b
Baseline completion rate based on subjects having any baseline data with no post-baseline data requirement.
c
Follow-up visit 1 = 30 d from the last dose (± 7 d) or coinciding with the date of discontinuation (±7 d) if date of discontinuation is greater than 37 d after last dose; follow-up visit 2 = 84 d (± 7 d) from follow-up visit 1.