Table 4.
Prevalence of probably or possibly treatment-related adverse events (AEs) by organ system
| Adverse events | Chewable tablet, calcium ± vitamin D3 (N = 102) | Sachet, calcium ± vitamin D3 (N = 97) | ||
|---|---|---|---|---|
| n (%) | AE | n (%) | AE | |
| All | 21 (21) | 23 | 20 (21) | 22 |
| Gastro-intestinal disorders (total) | 20 (20) | 21 | 19 (20) | 21 |
| Constipation | 9 (9) | 9 | 5 (5) | 5 |
| Nausea | 5 (5) | 5 | 6 (6) | 6 |
| Upper abdominal pain | 1 (1) | 1 | 1 (1) | 1 |
| Flatulence | 2 (2) | 2 | 2 (2) | 2 |
| Eructation | 0 (0) | 0 | 2 (2) | 2 |
| Diarrhoea NOS | 0 (0) | 0 | 4 (4) | 4 |
| Dyspepsia | 1 (1) | 1 | 1 (1) | 1 |
| Stomach discomfort | 2 (2) | 2 | 0 (0) | 0 |
| Aphthous stomatitis | 1 (1) | 1 | 0 (0) | 0 |
| Nervous system disorders | ||||
| Headache | 1 (1) | 1 | 0 (0) | 0 |
| Renal and urinary disorder (total) | ||||
| Abnormal urine NOS | 0 (1) | 0 | 1 (1) | 1 |
| Skin disorders | ||||
| Pruritus | 1 (1) | 1 | 0 (0) | 0 |
N number of subjects exposed to treatment, n number of subjects with event, AE number of adverse events, % percentage of subjects with adverse event (n) per subjects exposed (N)