Table 2.
Adverse Drug Reactions
| Event | Total | ≥ 65 yr | ≥ 75 yr |
|---|---|---|---|
| Safety analysis population | 1049 | 763 | 531 |
| Patients with ADRs | 55 (5.24) | 34 (4.46) | 19 (3.58) |
| Gastrointestinal disorders | 52 (4.96) | 31 (4.06) | 16 (3.01) |
| Diarrhea | 23 (2.19) | 16 (2.10) | 7 (1.32) |
| Abdominal pain | 19 (1.81) | 11 (1.44) | 5 (0.94) |
| Abdominal distension | 4 (0.38) | 2 (0.26) | 2 (0.38) |
| Nausea | 3 (0.29) | 1 (0.13) | 1 (0.19) |
| Abdominal discomfort | 2 (0.19) | 0 (0.00) | 0 (0.00) |
| Constipation | 2 (0.19) | 2 (0.26) | 0 (0.00) |
| Eructation | 1 (0.10) | 0 (0.00) | 0 (0.00) |
| Vomiting | 1 (0.10) | 1 (0.13) | 1 (0.19) |
| Soft feces | 1 (0.10) | 1 (0.13) | 1 (0.19) |
| Anal incontinence | 1 (0.10) | 1 (0.13) | 1 (0.19) |
| Skin and subcutaneous tissue disorders | 1 (0.10) | 1 (0.13) | 1 (0.19) |
| Rash | 1 (0.10) | 1 (0.13) | 1 (0.19) |
| Nervous system disorders | 1 (0.10) | 1 (0.13) | 1 (0.19) |
| Headache | 1 (0.10) | 1 (0.13) | 1 (0.19) |
| General disorders and administration site conditions | 1 (0.10) | 1 (0.13) | 1 (0.19) |
| Death | 1 (0.10) | 1 (0.13) | 1 (0.19) |
ADR, adverse drug reaction.
Data are presented as n (%) of patients who experienced each event.