Table 8.
Comparison of adverse events.
| All (n = 63) |
rhGH (n = 31) |
Placebo (n = 32) |
p-value | |
|---|---|---|---|---|
| None reported | 36 (57.1) | 19 (61.3) | 17 (53.1) | |
| Arthralgia | 8 (12.7) | 2 (6.5) | 6 (18.8) | 0.256 |
| Myalgia | 7 (11.1) | 1 (3.2) | 6 (18.8) | 0.104 |
| Headache | 4 (6.3) | 1 (3.2) | 3 (9.4) | 0.613 |
| Elective surgery | 10 (15.9) | 6 (19.4) | 4 (12.5) | 0.509 |
| Urinary issue | 3 (4.8) | 0 (0) | 3 (9.4) | 0.238 |
| Back pain | 1 (1.6) | 1 (3.2) | 0 (0) | 0.492 |
| Broken ribs and scapula | 1 (1.6) | 0 (0) | 1 (3.1) | 1.0 |
| Bruising at injection site | 1 (1.6) | 1 (3.2) | 0 (0) | 0.492 |
| Drowsiness | 2 (3.2) | 1 (3.2) | 1 (3.1) | 1.0 |
| Dizziness | 1 (1.6) | 1 (3.2) | 0 (0) | 0.492 |
| Dry mouth | 4 (6.3) | 1 (3.2) | 3 (9.4) | 0.613 |
| Eye puffiness | 1 (1.6) | 0 (0) | 1 (3.1) | 1.0 |
| Hair growth | 1 (1.6) | 1 (3.2) | 0 (0) | 0.492 |
| Hair loss | 1 (1.6) | 0 (0) | 1 (3.1) | 1.0 |
| Weight gain | 1 (1.6) | 0 (0) | 1 (3.1) | 1.0 |
| Irritability | 1 (1.6) | 0 (0) | 1 (3.1) | 1.0 |
| Numbness in extremities | 1 (1.6) | 0 (0) | 1 (3.1) | 1.0 |
| Peripheral edema | 1 (1.6) | 0 (0) | 1 (3.1) | 1.0 |
| Seizure | 2 (3.2) | 2 (6.5) | 0 (0) | 0.613 |
| Greatest Action Taken | 0.317 | |||
| Not Applicable (N/A) | 36 (57.1) | 19 (61.3) | 17 (53.1) | |
| None required | 15 (23.8) | 9 (29) | 6 (18.8) | |
| Treatment given | 7 (11.1) | 1 (3.2) | 6 (18.8) | |
| Study drug temporarily stopped | 2 (3.2) | 0 (0) | 2 (6.3) | |
| Study drug discontinued | 3 (4.8) | 2 (6.5) | 1 (3.1) |