Table 2.
Differences between cases and controls and the results of the univariate analysis.
| Cases n (%) n = 42 | Controls n (%) n = 168 | Univariate analysis odds ratio (95% CI) | |
|---|---|---|---|
| How new is the association or the drug? | |||
| ADR unlabelled | 27 (64) | 67 (40) | 2.7 (1.3, 5.5) |
| Suspected drug shorter than 5 years marketed | 17 (41) | 39 (23) | 2.2 (1.1, 4.6) |
| Factors related to strength of the association | |||
| Absolute number of reports | |||
| 1 or 2 reports (reference category) | 22 (52) | 69 (41) | 1 (ref) |
| 3 or 4 reports | 8 (19) | 28 (17) | 0.9 (0.4, 2.3) |
| More than 4 reports | 12 (29) | 71 (42) | 0.5 (0.2, 1.2) |
| ROR full ATC code/preferred term statistically significant (lower limit 95% CI > 1) | 23 (55) | 46 (27) | 3.2 (1.6, 6.4) |
| Factors related to the seriousness of the reaction involved | |||
| Index or control report concerns a ‘serious’ ADR | 21 (50) | 20 (12) | 7.4 (3.5, 16) |
| WHO critical term present | 26 (62) | 30 (18) | 7.5 (3.6, 16) |
| Factors related to documentation of the reports to the SRS | |||
| Index or control report mentions a positive dechallenge | 17 (41) | 60 (36) | 1.2 (0.6, 2.5) |
| Index or control report mentions a positive rechallenge | 4 (10) | 16 (10) | 1.0 (0.3, 3.2) |
| Source of reports: number of reports by physicians | 31 (73.8) | 107 (64) | 1.6 (0.8, 3.4) |