Table 3.
Total serious adverse events stratified by patient characteristics
| No.a | All-causality | Treatment-related | |
|---|---|---|---|
| Duration of rhGH treatment, y | |||
| < 3 y | 39 443 | 1039 (2.6) | 280 (0.7) |
| ≥ 3 y | 44 360 | 2069 (4.7) | 327 (0.7) |
| P | < .0001 | ≥ .999 | |
| Diagnosis | |||
| Idiopathic GHD | 39 298 | 743 (1.9) | 137 (0.3) |
| Neurosecretory dysfunction | 2187 | 41 (1.9) | 7 (0.3) |
| Congenital GHD | 3323 | 213 (6.4) | 21 (0.6) |
| Craniopharyngioma | 1381 | 268 (19.4) | 68 (4.9) |
| Medulloblastoma | 998 | 117 (11.7) | 20 (2.0) |
| Other cranial tumors | 1750 | 228 (13.0) | 56 (3.2) |
| Extracranial malignancy | 940 | 76 (8.1) | 19 (2.0) |
| Idiopathic short stature | 6867 | 73 (1.1) | 16 (0.2) |
| Turner syndrome | 7714 | 293 (3.8) | 68 (0.9) |
| Prader-Willi syndrome | 2338 | 175 (7.5) | 52 (2.2) |
| Other syndromes | 2602 | 163 (6.3) | 24 (0.9) |
| Small for gestational age | 7936 | 175 (2.2) | 19 (0.2) |
| Chronic renal failure | 2399 | 333 (13.9) | 61 (2.5) |
| Other causes | 4070 | 210 (5.2) | 39 (1.0) |
| P | < .0001 | < .0001 |
Abbreviations: GHD, growth hormone deficiency; rhGH, recombinant human growth hormone.
a
No. was used a denominator to calculated percentages in each row.