| Variable | Ranitidine HCl 150 mg BID | Ranitidine HCl 300 mg OD or BID | Ranitidine Hydrochloride 300 mg OD | Total N (%) |
| Patients enrolled in the study | 1601 | 753 | 74 | 2428 |
| Patients with AE n (%) | 70 (4.37) | 53 (7.03) | 5 (6.75) | 128 (5.27) |
| Severity n (%) |
|
|
|
|
| Mild | 62 (88.57) | 47 (88.67) | 4 (80) | 113 (88.28) |
| Moderate | 08 (11.43) | 06 (11.32) | 01 (20) | 15 (11.71) |
| Severe | 00 | 00 | 00 | 00 |
| Causality n (%) |
|
|
|
|
| Related | 05 (7.14) | 05 (9.43) | 01 (20) | 11 (8.59) |
| Not Related | 65 (92.85) | 48 (90.56) | 04 (80) | 117 (91.4) |