Table 3.
Self-reported adverse and serious adverse events among the study participants.
| Low load | High load | p-value | |
|---|---|---|---|
| (N = 37) | (N = 35) | ||
| Any adverse events, n (%) | |||
| Musculoskeletal disorders | 1 (2.7) | 7 (20.0) | p < 0.05 |
| Arthralgia | 0 (0) | 1 (2.9) | NS |
| Myalgia | 1 (2.7) | 2 (5.7) | NS |
| Pain in lower extremity | 0 (0) | 2 (5.7) | NS |
| Swelling of ankle and/or foot | 0 (0) | 2 (5.7) | NS |
| Other | 5 (13.5) | 6 (17.1) | NS |
| Hyperhidrosis | 3 (8.1) | 0 (0) | NS |
| Decreased appetite | 0 (0) | 4 (11.4) | NS |
| Increased appetite | 0 (0) | 1 (2.9) | NS |
| Fatigue | 1 (2.7) | 1 (2.9) | NS |
| Uncomfortable feeling | 1 (2.7) | 0 (0) | NS |
| Infections | 1 (2.7) | 3 (8.6) | NS |
| Influenza | 0 (0) | 1 (2.9) | NS |
| Upper respiratory infection | 1 (2.7) | 2 (5.7) | NS |
| Nervous system disorder | 0 (0) | 1 (2.9) | NS |
| Migraine | 0 (0) | 1 (2.9) | NS |
| Gastrointestinal disorder | 0 (0) | 0 (0) | NS |
| Heart and/or lung disorder | 0 (0) | 0 (0) | NS |
| Injury | 0 (0) | 0 (0) | NS |
| Adverse events leading to discontinuation of trial#, n (%) | |||
| Musculoskeletal disorders | 1 (2.7) | 1 (2.9) | NS |
| Myalgia | 1 (2.7) | 0 (0) | NS |
| Pain in lower extremity | 0 (0) | 1 (2.9) | NS |
| Infection | 0 (0) | 1 (2.9) | NS |
| Influenza | 0 (0) | 1 (2.9) | NS |
| #One participant in the low load group and two participants in the high load group discontinued the trial | |||
| Participants with any adverse event, n (%) | 6 (16.2) | 13 (37.1) | p < 0.05 |
| Participants with any treatment-related adverse event, n (%) | 5 (13.5) | 5 (14.3) | NS |
| Number of treatment-related adverse events | 5 | 6 | NS |
| Any serious adverse event, n (%) | 0 (0) | 0 (0) | NS |
| Any treatment-related serious adverse event, n (%) | 0 (0) | 0 (0) | NS |
Adverse events are presented as number of events together with percentage for all subjects who were randomized.