Table 6.
Adverse events in main trial and extension (safety analysis set)
| Somapacitan (0.04 mg/kg/wk) | Somapacitan (0.08 mg/kg/wk) | Somapacitan (0.16 mg/kg/wk) | Daily GH (0.034 mg/kg/d) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| N | (%) | E | R | N | (%) | E | R | N | (%) | E | R | N | (%) | E | R | |
| Patients exposed | 16 | 15 | 14 | 14 | ||||||||||||
| All events | 10 | (62.5) | 28 | 196.3 | 11 | (73.3) | 46 | 304.9 | 13 | (92.9) | 52 | 364.8 | 14 | (100.0) | 48 | 364.1 |
| Mild events | 7 | (43.8) | 15 | 105.2 | 11 | (73.3) | 44 | 291.6 | 11 | (78.6) | 42 | 294.6 | 14 | (100.0) | 44 | 333.8 |
| Moderate events | 4 | (25.0) | 11 | 77.1 | 1 | (6.7) | 2 | 13.3 | 6 | (42.9) | 10 | 70.1 | 3 | (21.4) | 4 | 30.3 |
| Severe events | 2 | (12.5) | 2 | 14.0 | 0 | 0 | 0 | |||||||||
| Probably related | 2 | (12.5) | 2 | 14.0 | 0 | 1 | (7.1) | 2 | 14.0 | 1 | (7.1) | 1 | 7.6 | |||
| Possibly related | 0 | 1 | (6.7) | 2 | 13.3 | 1 | (7.1) | 1 | 7.0 | 0 | ||||||
| Unlikely related | 10 | (62.5) | 26 | 182.3 | 11 | (73.3) | 44 | 291.6 | 13 | (92.9) | 49 | 343.7 | 14 | (100.0) | 47 | 356.5 |
Only adverse events with an onset after the first administration of trial product and up until week 52 or 14 days after last trial drug administration, whichever comes first, are included. Values in bold are “All events”. All others are sub-categories.
Abbreviations: %, percentage of patients; d, day; E, number of events; GH, growth hormone; N, number of patients; R, event rate per 100 patient-years at risk; wk, week.