Table 3.
Other treatment related adverse events
| Event* | Methylcobalamin group (n=117) | Placebo group (n=117) | P value for difference in any grade† | |||
|---|---|---|---|---|---|---|
| Any grade | Grade 3-4 | Any grade | Grade 3-4 | |||
| Any | 88 (75.2) | 12 (10.3) | 95 (81.2) | 18 (15.4) | 0.27 | |
| Lymphopenia | 46 (39.3) | 10 (8.5) | 55 (47.0) | 13 (11.1) | 0.23 | |
| Leukopenia | 35 (29.9) | 4 (3.4) | 35 (29.9) | 3 (2.6) | 1.00 | |
| Anaemia | 33 (28.2) | 0 | 36 (30.8) | 0 | 0.67 | |
| Neutropenia | 33 (28.2) | 3 (2.6) | 33 (28.2) | 6 (5.1) | 1.00 | |
| ALT increased | 25 (21.4) | 0 | 20 (17.1) | 0 | 0.41 | |
| ALP increased | 23 (19.7) | 0 | 18 (15.4) | 0 | 0.39 | |
| AST increased | 20 (17.1) | 0 | 24 (20.5) | 0 | 0.50 | |
| Platelet count decreased | 20 (17.1) | 0 | 25 (21.4) | 1 (0.9) | 0.41 | |
| Diarrhoea | 18 (15.4) | 0 | 15 (12.8) | 0 | 0.57 | |
| Stomatitis | 17 (14.5) | 1 (0.9) | 12 (10.3) | 0 | 0.32 | |
| Bilirubin level increased | 15 (12.8) | 0 | 20 (17.1) | 0 | 0.36 | |
| Fatigue | 12 (10.3) | 0 | 13 (11.1) | 0 | 0.83 | |
| Nausea | 8 (6.8) | 0 | 12 (10.3) | 0 | 0.35 | |
| Creatinine increased | 4 (3.4) | 0 | 3 (2.6) | 0 | 0.70 | |
| Vomiting | 3 (2.6) | 0 | 6 (5.1) | 0 | 0.31 | |
Data are numbers (%).
ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase.
*
Each patient was counted once for highest grade of each adverse event that occurred.
†
From Pearson’s χ2 test.