Table 1.
Completion and compliance rates for patient-reported outcome questionnaires
| QLQ-C30 |
QLQ-BR23 |
EQ-5D |
||||
|---|---|---|---|---|---|---|
| Neoadjuvant phase | Pembrolizumab + Chemotherapy n = 762 | Placebo + Chemotherapy n = 383 | Pembrolizumab + Chemotherapy n = 759 | Placebo + Chemotherapy n= 382 | Pembrolizumab + Chemotherapy n = 762 | Placebo + Chemotherapy n = 384 |
| Baseline | ||||||
| Completion, n (%)a | 701 (92.0) | 366 (95.6) | 695 (91.6) | 361 (94.5) | 707 (92.8) | 369 (96.1) |
| Compliance, n/N (%)b | 701/762 (92.0) | 366/382 (95.8) | 695/759 (91.6) | 361/381 (94.8) | 707/762 (92.8) | 369/383 (96.3) |
| Week 12 | ||||||
| Completion, n (%)a | 648 (85.0) | 329 (85.9) | 644 (84.8) | 328 (85.9) | 657 (86.2) | 336 (87.5) |
| Compliance, n/N (%)b | 648/711 (91.1) | 329/363 (90.6) | 644/709 (90.8) | 328/362 (90.6) | 657/711 (92.4) | 336/365 (92.1) |
| Week 21 | ||||||
| Completion, n (%)a | 615 (80.7) | 309 (80.7) | 611 (80.5) | 307 (80.4) | 616 (80.8) | 311 (81.0) |
| Compliance, n/N (%)b | 615/688 (89.4) | 309/349 (88.5) | 611/686 (89.1) | 307/348 (88.2) | 616/688 (89.5) | 311/350 (88.9) |
| Adjuvant phase | Pembrolizumab n = 539 | Placebo n = 308 | Pembrolizumab n = 538 | Placebo n = 306 | Pembrolizumab n = 540 | Placebo n = 310 |
|---|---|---|---|---|---|---|
| Baseline | ||||||
| Completion, n (%)a | 489 (90.7) | 283 (91.9) | 487 (90.5) | 282 (92.2) | 495 (91.7) | 285 (91.9) |
| Compliance, n/N (%)b | 489/539 (90.7) | 283/308 (91.9) | 487/538 (90.5) | 282/306 (92.2) | 495/540 (91.7) | 285/310 (91.9) |
| Week 12 | ||||||
| Completion, n (%)a | 485 (90.0) | 269 (87.3) | 483 (89.8) | 267 (87.3) | 485 (89.8) | 274 (88.4) |
| Compliance, n/N (%)b | 485/527 (92.0) | 269/302 (89.1) | 483/526 (91.8) | 267/300 (89.0) | 485/528 (91.9) | 274/304 (90.1) |
| Week 24 | ||||||
| Completion, n (%)a | 444 (82.4) | 249 (80.8) | 442 (82.2) | 247 (80.7) | 444 (82.2) | 249 (80.3) |
| Compliance, n/N (%)b | 444/484 (91.7) | 249/282 (88.3) | 442/483 (91.5) | 247/280 (88.2) | 444/485 (91.5) | 249/284 (87.7) |
EQ-5D = EuroQol 5-Dimension Questionnaire; PRO = patient-reported outcome; QLQ-BR23 = European Organisation for Research and Treatment of Cancer Breast Cancer–Specific Quality of Life Questionnaire; QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30.
Completion rate: number of patients who completed at least 1 score/item over the number of patients in the PRO full analysis set population at each time point.
Compliance rate: number of patients who completed at least 1 score/item over the number of patients expected to complete at each time point excluding those missing by design (eg, due to death, discontinuation, translation unavailable).