Table 2. Incidence of adverse events during on-treatment follow-up and whole study period.
| Variable | Total (n = 2,024)a |
IGHD (n = 1,189) |
OGHD (n = 107) |
TS (n = 197) |
SGA (n = 206) |
ISS (n = 315) |
CRF (n = 9) |
|---|---|---|---|---|---|---|---|
| On-treatment follow-up period: | |||||||
| AEs | 458 (22.6%) |
231 (19.4%) |
45 (42.1%) |
72 (36.6%) |
35 (17.0%) |
70 (22.2%) |
5 (55.6%) |
| ADRs | 93 (4.6%) |
43 (3.6%) |
13 (12.2%) |
11 (5.6%) |
8 (3.9%) |
17 (5.4%) |
1 (11.1%) |
| SAEs | 66 (3.3%) |
31 (2.6%) |
12 (11.2%) |
13 (6.6%) |
4 (1.9%) |
6 (1.9%) |
- |
| Serious ADRs | 7 (0.4%) |
4 (0.3%) |
2 (1.9%) |
1 (0.5%) |
- | - | - |
| Whole study period: | |||||||
| AEs | 462 (22.8%) |
232 (19.5%) |
46 (43.0%) |
73 (37.1%) |
35 (17.0%) |
70 (22.2%) |
6 (66.7%) |
| ADRs | 94 (4.6%) |
43 (3.6%) |
14 (13.1%) |
11 (5.6%) |
8 (3.9%) |
17 (5.4%) |
1 (11.1%) |
| SAEs | 68 (3.4%) |
31 (2.6%) |
13 (12.2%) |
13 (6.6%) |
4 (1.9%) |
6 (1.9%) |
1 (11.1%) |
| Serious ADRs* | 8 (0.4%) |
4 (0.3%) |
3 (2.8%) |
1 (0.5%) |
- | - | |
a Addition of each subgroup number does not sum up to 2,024 as one patient with GHD could not be classified as either IGHD or OGHD. The patient with non-specified GHD etiology did not experience any adverse event. Data show numbers (%) of patients with events.
*Total of nine serious ADRs were reported in eight patients during whole study period: autoimmune thyroiditis, hypothyroidism, diabetes mellitus, hematuria, intervertebral disc protrusion and supraventricular tachycardia (n = 1 each) and craniopharyngioma recurrence (n = 3). Except one case of craniopharyngioma recurrence, all occurred during on-treatment follow-up period.
ADR adverse drug reaction, AE adverse event, CRF chronic renal failure, GHD growth hormone deficiency, IGHD idiopathic growth hormone deficiency, ISS idiopathic short stature, OGHD organic growth hormone deficiency, SAE serious AE, SGA small for gestational age, TS Turner syndrome.