TABLE 5.
Adverse events regardless of study drug relationship by primary system organ class, preferred term, maximum grade and study group (safety set)
| Primary system organ class | Normal (n = 10) n (%) | Mild (n = 7) n (%) | Moderate (n = 8) n (%) | Severe (n = 6) n (%) | All participants (N = 31) n (%) |
|---|---|---|---|---|---|
| Preferred term | |||||
| Any primary system organ class | 0 | 3 (42.9) | 2 (25.0) | 1 (16.7) | 6 (19.4) |
| Grade 1 | 0 | 2 (28.6) | 2 (25.0) | 1 (16.7) | 5 (16.1) |
| Grade 2 | 0 | 1 (14.3) | 0 | 0 | 1 (3.2) |
| Ear and labyrinth disorders | 0 | 1 (14.3) | 0 | 0 | 1 (3.2) |
| Vertigo | 0 | 1 (14.3) | 0 | 0 | 1 (3.2) |
| Gastrointestinal disorders | 0 | 0 | 2 (25.0) | 1 (16.7) | 3 (9.7) |
| Nausea | 0 | 0 | 2 (25.0) | 0 | 2 (6.5) |
| Diarrhoea | 0 | 0 | 0 | 1 (16.7) | 1 (3.2) |
| Flatulence | 0 | 0 | 0 | 1 (16.7) | 1 (3.2) |
| General disorders and administration site conditions | 0 | 1 (14.3) | 0 | 0 | 1 (3.2) |
| Medical device site dermatitis | 0 | 1 (14.3) | 0 | 0 | 1 (3.2) |
| Metabolism and nutrition disorders | 0 | 1 (14.3) | 0 | 0 | 1 (3.2) |
| Hypoglycaemia | 0 | 1 (14.3) | 0 | 0 | 1 (3.2) |
| Nervous system disorders | 0 | 1 (14.3) | 1 (12.5) | 0 | 2 (6.5) |
| Headache | 0 | 1 (14.3) | 1 (12.5) | 0 | 2 (6.5) |
| Dizziness | 0 | 0 | 1 (12.5) | 0 | 1 (3.2) |
Primary system organ classes are presented alphabetically; preferred terms are sorted within primary system organ class in descending frequency, as reported in the All participants column. A participant with multiple occurrences of an adverse event (AE) under 1 study group is counted only once in the AE category for that study group. A participant with multiple severity ratings for an AE while on a study group is only counted under the maximum rating. A participant with multiple AEs within a primary system organ class is counted only once in the total row at maximum severity grade.