Adjudicated assessments of ADE causality (certain, probable or possible), preventability (definitely or possibly) and seriousness (mild, moderate, severe, death)
| ADE causality | Definitely preventable | Death | Severe | Moderate | Mild | Possibly preventable | Death | Severe | Moderate | Mild | Total |
| Certain (31/120, 25.8%) | 22 | 0 | 4 | 18 | 0 | 9 | 0 | 5 | 4 | 0 | 31 (25.8%) |
| Probable (51/120, 42.5%) | 9 | 0 | 1 | 8 | 0 | 42 | 0 | 2 | 40 | 0 | 51 (42.5%) |
| Possible (38/120, 31.7%) | 5 | 1 | 0 | 4 | 0 | 33 | 1 | 7 | 24 | 1 | 38 (31.7%) |
| Total | 36/120 (37.5%) | 1 (0.08%) | 5 (0.04%) | 30 (25%) | 0 | 84/120 (62.5%) | 1 (0.08%) | 14 (11.7%) | 68 (56.7%) | 1 (0.08%) | 120 |
ADE, adverse drug event.