Summary of data reported by product information document
| Europe | USA | ||
|---|---|---|---|
| Item | Median (IQR) | Median (IQR) | |
| Adverse Drug Reaction | Number ADRs | 114 (93, 150) | 201 (114, 262) |
| Data source of ADR report | (1) Clinical trial | 3 (1, 84) | 172 (58, 256) |
| (2) Spontaneous report/other | 4 (1, 9) | 8 (2, 14) | |
| (3) Unspecified | 88 (1, 112) | 9 (1, 35) | |
| Document level reporting | n (%) | n (%) | |
| Documents reporting items for >80% of clinical trial ADRs | (1) Number of participants | 2 (17) | 8 (66) |
| (2) Risk estimates | 5 (41) | 9 (75) | |
| (3) Risk estimates by severity | 0 (0) | 1 (8) | |
| (4) Length of study | 0 (0) | 3 (25) | |
| Is any information on ADR risk reported by: | (1) Indication (yes) | 2 (17) | 9 (75) |
| (2) Dose (yes) | 0 (0) | 4 (33) | |
| Did the document contain any information on: | (1) Recurrent ADRs (yes) | 0 (0) | 0 (0) |
| (2) Duration of ADR (yes) | 0 (0) | 1 (8) |
ADRs, adverse drug reactions; IQR, Interquartile range.