Table 3. Incidence of adverse events of interest during 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) |
---|---|---|---|---|---|---|---|
Death | 1 (14) | 1 (23) | - | - | - | - | - |
All neoplasms | 14 (191) | 4 (93) | 7 (1289) | 3 (255) | - | - | - |
Malignancy | 9 (123) | 1 (23) | 7 (1289) | 1 (85) | - | - | - |
Benign | 5 (68) | 3 (70) | 2 (170) | - | - | - | |
Hypothyroidism | 22 (300) | 6 (140) | 3 (552) | 11 (937) | - | 1 (118) | 1† |
Glucose intolerance* | 7 (95) | 2 (47) | 3 (552) | - | 1 (218) | 1 (118) | - |
Scoliosis | 11 (150) | 7 (163) | 1 (184) | 2 (170) | 1 (218) | - | - |
Benign intracranial hypertension | 1 (14) | 1 (23) | - | - | - | - | - |
Pancreatitis | 1 (14) | 1 (23) | - | - | - | - | - |
Fluid retention | 1 (14) | 1 (23) | - | - | - | - | - |
Gynecomastia | 1 (14) | - | - | - | - | 1 (118) | - |
Sleep apnea syndrome | 1 (14) | 1 (23) | - | - | - | - | - |
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 absolute numbers (rates per 100,000 patient-years).
*Includes diabetes mellitus (n = 3), hyperglycemia (n = 3) and glucose tolerance impaired (n = 1),
†Due to small sample size, rates per 100,000 patient-years of chronic renal failure cohort was not analyzed separately.
CRF chronic renal failure, GHD growth hormone deficiency, IGHD idiopathic growth hormone deficiency, ISS idiopathic short stature, OGHD organic growth hormone deficiency, SGA small for gestational age, TS Turner syndrome.