Table 4.
Adverse events | Intervention, n (%) | Control, n (%) | |||||||
|
Before enrollment (n=22) | 0-4 weeks (n=17) | 5-8 weeks (n=20) | 9-12 weeks (n=19) | Before enrollment (n=22) | 0-4 weeks (n=17) | 5-8 weeks (n=15) | 9-12 weeks (n=19) | |
Total adverse events | 51 | 40 | 48 | 38 | 38 | 31 | 20 | 22 | |
Low back pain | 7 (14) | 4 (10) | 5 (10) | 6 (16) | 4 (11) | 1 (3) | 1 (5) | 2 (9) | |
Knee pain | 2 (4) | 2 (5) | 2 (4) | 1 (3) | 1 (3) | 0 (0) | 0 (0) | 1 (5) | |
Shoulder pain | 3 (6) | 2 (5) | 5 (10) | 2 (5) | 4 (11) | 1 (3) | 0 (0) | 0 (0) | |
Inflammation of the joints | 2 (4) | 2 (5) | 2 (4) | 0 (0) | 1 (3) | 2 (6) | 1 (5) | 1 (5) | |
Chest pain | 0 (0) | 1 (3) | 2 (4) | 1 (3) | 1 (3) | 0 (0) | 0 (0) | 0 (0) | |
Shortness of breath | 5 (10) | 3 (8) | 4 (8) | 5 (13) | 2 (5) | 0 (0) | 0 (0) | 1 (5) | |
Fatigue | 18 (35) | 13 (33) | 16 (33) | 14 (37) | 12 (32) | 13 (42) | 11 (55) | 12 (55) | |
Leg cramping | 4 (8) | 3 (8) | 2 (4) | 1 (3) | 2 (5) | 4 (13) | 1 (5) | 1 (5) | |
Muscle pain | 4 (8) | 3 (8) | 4 (8) | 2 (5) | 2 (5) | 3 (10) | 1 (5) | 0 (0) | |
Dizziness or vertigo | 2 (4) | 1 (3) | 3 (6) | 2 (5) | 2 (5) | 2 (6) | 1 (5) | 1 (5) | |
Other orthopedic limitation | 1 (2) | 2 (5) | 0 (0) | 0 (0) | 1 (3) | 2 (6) | 2 (10) | 1 (5) | |
Doctor’s visit, excluding standard cancer follow-up | 3 (6) | 4 (10) | 3 (6) | 4 (11) | 3 (8) | 2 (6) | 2 (10) | 1 (5) | |
Hospitalizationb | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (8) | 1 (3) | 0 (0) | 0 (0) | |
Deathc | N/Ad | 0 (0) | 0 (0) | 0 (0) | N/A | 0 (0) | 0 (0) | 1 (5) |
aParticipants were asked at the time of enrollment to report if they had experienced any adverse events in the past month. The survey was repeated at 4, 8, and 12 weeks.
bReasons for hospitalization in the month before enrollment included anemia, infection, and fever after receipt of chemotherapy, and at 0-4 weeks, stomach perforation.
cOne participant in the control arm expired while enrolled in the study because of cancer progression.
dN/A: not applicable.