|  | baseline | 6 mo | 12 mo | 18 mo | 24 mo |  |  | |||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 | Ref | Arm A | Arm B | Arm A | Arm B | Arm A | Arm B | Arm A | Arm B | Arm A | Arm B | p-valueb | p-valuec |
 Physical Functioning | 81.6 (18.7) | 69.2 (4.8) | 72.8 (4.5) | 71.1 (4.8) | 75.4 (4.7) | 70.1 (4.8) | 73.1 (4.7) | 65.7 (6.1) | 70.1 (5.8) | 62.4 (5.9) | 70.1 (5.4) | 0.4585 | 0.3822 |
 Role Functioning | 67.4 (31.1) | 65.5 (6.3) | 69.2 (5.7) | 62.3 (6.4) | 65.9 (6.4) | 65.8 (6.0) | 67.9 (5.9) | 58.7 (7.8) | 69.7 (7.3) | 56.4 (8.8) | 68.8 (7.9) | 0.3676 | 0.8800 |
 Emotional Functioning | 65.9 (24.6) | 58.1 (4.3) | 62.3 (4.1) | 62.5 (5.0) | 71.4 (5.0) | 68.2 (4.5) | 73.6 (4.4) | 65.2 (5.5) | 69.6 (5.2) | 69.5 (6.3) | 70.6 (5.4) | 0.4128 | 0.0127 |
 Cognitive Functioning | 80.5 (23.2) | 89.3 (2.9) | 91.6 (2.8) | 79.5 (4.1) | 83.5 (4.1) | 82.0 (4.3) | 82.5 (4.3) | 78.6 (5.1) | 81.5 (4.9) | 74.3 (5.2) | 83.3 (4.5) | 0.4537 | 0.0058 |
 Social Functioning | 74.2 (28.4) | 65.9 (5.6) | 76.1 (5.3) | 68.6 (5.7) | 78.6 (5.8) | 76.9 (5.7) | 78.2 (5.6) | 70.9 (7.4) | 72.1 (6.7) | 74.3 (6.2) | 77.2 (5.3) | 0.5507 | 0.3784 |
 Global health status/QoL | 60.2 (25.5) | 47.8 (4.3) | 61.6 (4.2) | 61.4 (4.5) | 68.7 (4.5) | 66.0 (4.2) | 69.7 (4.2) | 63.5 (6.3) | 68.7 (5.8) | 61.4 (5.9) | 71.2 (4.9) | 0.2194 | 0.0032 |
 Fatigue | 36.3 (27.0) | 39.3 (5.1) | 34.0 (4.7) | 43.2 (5.7) | 35.2 (5.6) | 41.8 (5.6) | 37.4 (5.4) | 40.8 (6.4) | 32.0 (5.9) | 47.5 (5.7) | 31.2 (5.1) | 0.1717 | 0.6495 |
 Nausea/Vomiting | 10.3 (19.7) | 10.5 (2.9) | 5.6 (2.7) | 9.3 (2.6) | 4.9 (2.6) | 11.9 (3.7) | 6.9 (3.7) | 8.0 (3.4) | 6.0 (3.1) | 18.8 (6.0) | 9.4 (5.4) | 0.1930 | 0.2564 |
 Pain | 30.9 (29.6) | 37.9 (6.2) | 32.2 (5.7) | 30.9 (5.5) | 22.7 (5.5) | 25.7 (5.1) | 24.1 (5.1) | 28.6 (6.4) | 28.3 (6.0) | 32.4 (6.6) | 26.2 (6.0) | 0.5478 | 0.2441 |
 Dyspnoea | 20.4 (28.2) | 15.7 (4.6) | 19.1 (4.3) | 22.6 (5.3) | 24.5 (5.2) | 21.9 (5.8) | 28.3 (5.7) | 34.9 (8.8) | 36.7 (8.2) | 37.1 (6.9) | 26.5 (6.4) | 0.9850 | 0.0257 |
 Insomnia | 33.1 (32.6) | 39.5 (5.6) | 35.4 (5.3) | 36.9 (5.7) | 22.1 (5.7) | 32.8 (6.1) | 30.5 (6.0) | 24.5 (7.0) | 37.1 (6.5) | 32.0 (7.1) | 31.0 (6.3) | 0.8455 | 0.5016 |
 Appetite loss | 21.7 (31.0) | 23.3 (5.7) | 20.9 (5.2) | 22.8 (5.7) | 11.7 (5.7) | 20.2 (5.2) | 14.9 (5.2) | 17.3 (5.0) | 11.6 (4.5) | 23.3 (5.7) | 13.1 (5.0) | 0.1297 | 0.5374 |
 Constipation | 19.2 (28.8) | 18.9 (5.1) | 21.0 (4.9) | 25.3 (6.4) | 19.9 (6.4) | 19.4 (5.5) | 21.9 (5.5) | 11.3 (6.3) | 21.3 (5.9) | 18.3 (7.9) | 22.6 (6.8) | 0.6710 | 0.5871 |
 Diarrhoea | 5.8 (15.2) | 3.9 (3.2) | 8.7 (3.1) | 10.1 (4.8) | 9.0 (4.6) | 12.9 (3.6) | 4.9 (3.5) | 13.8 (4.9) | 6.7 (4.7) | 7.7 (3.3) | 4.4 (3.1) | 0.2765 | 0.2127 |
 Financial Problems |  | 16.3 (4.4) | 9.4 (4.1) | 27.4 (5.2) | 11.2 (5.1) | 27.1 (5.9) | 18.8 (5.7) | 27.3 (6.5) | 23.8 (6.2) | 19.5 (5.3) | 18.3 (4.9) | 0.2845 | 0.0308 |
 Body image | 81.9 (22.6) | 83.2 (3.7) | 83.2 (3.5) | 71.2 (5.4) | 78.1 (5.2) | 82.9 (4.2) | 81.7 (4.0) | 78.5 (5.3) | 79.5 (4.8) | 73.1 (5.6) | 74.9 (5.1) | 0.7139 | 0.0178 |
 Sexual functioning | 19.2 (23.2) | 12.6 (4.4) | 18.5 (4.2) | 17.4 (4.5) | 17.2 (4.4) | 15.6 (5.7) | 24.3 (5.4) | 18.6 (6.2) | 22.5 (5.2) | 12.6 (6.0) | 24.6 (5.2) | 0.3300 | 0.7514 |
 Future perspective | 47.6 (34.1) | 21.4 (5.4) | 45.0 (5.0) | 33.8 (6.1) | 42.5 (5.9) | 46.0 (6.5) | 49.9 (6.2) | 31.0 (7.7) | 49.5 (6.9) | 52.2 (8.2) | 54.8 (7.5) | 0.2336 | 0.0093 |
 Systematic therapy | 15.8 (14.3) | 18.4 (3.0) | 17.0 (2.7) | 31.9 (4.1) | 27.9 (4.1) | 21.4 (3.0) | 17.8 (2.9) | 25.1 (4.0) | 23.9 (3.7) | 23.3 (3.5) | 21.9 (3.2) | 0.5214 | <.0001 |
 Breast symptoms | 17.6 (16.7) | 26.7 (3.4) | 14.1 (3.2) | 20.1 (3.0) | 8.8 (3.0) | 13.7 (2.6) | 9.9 (2.6) | 10.4 (3.9) | 12.0 (3.6) | 7.3 (3.9) | 10.6 (3.6) | 0.4559 | 0.0056 |
 Arm symptoms | 21.0 (21.1) | 18.1 (3.2) | 14.2 (3.0) | 28.3 (4.3) | 14.5 (4.2) | 23.7 (4.0) | 15.1 (3.8) | 29.1 (5.1) | 19.2 (4.8) | 18.3 (4.7) | 15.8 (4.4) | 0.0949 | 0.0575 |
 Hair loss | 5.3 (19.3) | 2.6 (2.6) | 4.6 (2.4) | 32.5 (7.1) | 27.6 (7.1) | 16.3 (4.8) | -0.4 (4.3) | 18.3 (5.5) | 8.0 (5.0) | 9.9 (7.6) | 13.0 (6.8) | 0.2203 | <.0001 |