Table 2.
Classification and assessment of ADRS. Classification was done according to Wills & Brown [7] and causalty assessment was done according to Naranjo et al.[6]. Outcomes were assessed according to Hartwig et al. [8]. The treatment details were assessed based on the number of patients (n = 121) where as for all other assessments, the n = 164 (total number of ADRs)
| Parameter | Number (%) (n = 164) |
|---|---|
| Type of reaction# | |
| Type A Augmented reactions | 61 (37.2%) |
| Type B Bugs reactions | – |
| Type C Chemical reactions | – |
| Type D Delivery reactions | 3 (1.8%) |
| Type E Exit reactions | – |
| Type F Familial reaction | – |
| Type G Genotoxicity reactions | – |
| Type H Hypersensitivity reactions | 100 (61%) |
| Type U Unclassified reactions | – |
| Causality* | |
| Definite | 10 (6.1%) |
| Probable | 102 (62.2%) |
| Possible | 52 (31.7%) |
| Onset of ADRs | |
| Acute (<1 h) | 7 (4.3%) |
| Sub-acute (1–24 h) | 91 (55.5%) |
| Latent (>2 days) | 62 (37.8%) |
| Unknown | 4 (2.4%) |
| Severity | 88 (53.7%) |
| Mild | 88 (53.7%) |
| Moderate | 58 (35.4%) |
| Severe | 18 (10.9%) |
| Outcomes† | |
| Fatal | 0 |
| Fully Recovered | 119 (72.6%) |
| Recovering | 36 (%) |
| Unknown | 9 (%) |
| Treatment (n = 121) | |
| Stopped the medication | 37 (30.6%) |
| Reduced the dose | 9 (7.4%) |
| Added another drug | 16 (13.2%) |
| Substituted another drug | 27 (22.3%) |
| No change | 32 (26.4%) |