Table 2. Adverse event details in both arms. The numbers with percentages in brackets are depicted.
| Adverse event | Diclofenac arm (n = 66) | Tramadol arm (n = 62) | p value for any grade events | p value for grade 3 & above events | ||
|---|---|---|---|---|---|---|
| Any grade | Grade 3–5 | Any grade | Grade 3–5 | |||
| Mucositis | 66 (100) | 23 (34.8) | 62 (100) | 17 (27.4) | - | 0.47 |
| Dysphagia | 60 (90.9) | 20 (30.3) | 56 (90.3) | 12 (19.4) | 1 | 0.22 |
| Weight loss | 39 (59.1) | 1 (1.5) | 39 (62.9) | - | 0.72 | 1 |
| Nausea | 26 (39.4) | 2 (3) | 20 (32.3) | 2 (3.2) | 0.47 | 1 |
| Vomiting | 17 (25.8) | - | 18 (29) | 2 (3.2) | 0.7 | 0.23 |
| Constipation | 7 (11.3) | - | 13 (19.7) | - | 0.23 | - |
| Rise in creatinine | 7 (10.6) | - | 3 (4.8) | - | 0.33 | - |
| Hyponatraemia | 60 (90.9) | 17 (25.8) | 54 (87.1) | 17 (27.4) | 0.58 | 0.84 |
| Hypokalaemia | 4 (6.1) | 1 (1.5) | 8 (12.9) | 3 (4.8) | 0.23 | 0.35 |
| Hypomagnesaemia | 22 (33.3) | - | 28 (45.2) | 1 (1.6) | 0.21 | 0.48 |
| SGOT rise | 9 (13.6) | 1 (1.5) | 11 (17.7) | 1 (1.6) | 0.63 | 1 |
| SGPT rise | 12 (18.2) | 1 (1.5) | 14 (22.6) | 1 (1.6) | 0.66 | 1 |
| Anaemia | 53 (80.3) | 3 (4.5) | 54 (87.1) | - | 0.35 | 0.25 |
| Neutropenia | 15 (22.7) | 6 (9.1) | 21 (33.9) | 6 (9.7) | 0.17 | 1 |
| Thrombocytopenia | 14 (21.2) | 2 (3) | 15 (24.2) | 1 (1.6) | 0.83 | 1 |
SGOT, Serum glutamic-oxaloacetic transaminase; SGPT, Serum glutamic pyruvic transaminase