Table 4.
Characteristics of serious adverse events for biologic response modifiers with significant safety signals (EBGM ≥2).
| Drug | Adverse event (n) | Characteristics of reports |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Seriousness, n (%) |
Patient’s demographics |
Co-drugs |
|||||||
| Death | LT | HI | Age, year* | Sex** |
No. of Co-drugs* |
No. of reports without | |||
| M | F | ||||||||
| Antithymocyte Ig | Therap. response decreased (10) | — | — | 6 (60) | 43 (17–57) | 5 (50) | 5 (50) | 2 (2–4) | — |
| Pulmonary edema (16) | 4 (25) | 2 (13) | 6 (38) | 54 (13–70) | 7 (44) | 9 (56) | 7 (0–44) | 2 | |
| Hypotension (15) | 2 (13) | 6 (40) | 5 (33) | 52 (13–70) | 11 (73) | 3 (20) | 4 (0–21) | 2 | |
| Serum sickness (10) | — | — | 7 (70) | 37 (24–61) | 6 (60) | 4 (40) | 6 (3–38) | — | |
| Infusion related reaction (10) | 2 (20) | 1 (10) | 1 (10) | 47 (24–67) | 4 (40) | 3 (30) | 2 (0–16) | 4 | |
| Anaphylactic reaction (7) | 2 (29) | 3 (43) | 2 (29) | 48 (15–52) | 4 (57) | 3 (43) | 0 (0–20) | 4 | |
| Azathioprine | Alternaria infection (6) | 2 (33) | — | — | 64 (28–67) | 6 (100) | — | 2 (2–3) | — |
| Fungal skin infection (5) | 2 (40) | — | — | 65 (48–67) | 5 (100) | — | 2 (2–3) | — | |
| Lymphoproliferative disorder (7) | 2 (29) | — | 2 (39) | 21 (5–37) | 3 (43) | 3 (43) | 2 (1–7) | — | |
| Cyclosporine | Neurotoxicity (19) | 14 (74) | — | 1 (5) | 36 (17–49) | 9 (47) | 10 (53) | 1 (1–4) | — |
| Graft versus host disease (28) | 17 (61) | — | 4 (14) | 37 (11–73) | 12 (43) | 12 (43) | 1 (1–15) | — | |
| Thyroid cancer (11) | — | — | — | 40 (23–57) | 5 (45) | 6 (55) | 2 | — | |
| Cyclophosphamide | Disease progression (9) | 9 (100) | — | — | U | U | U | 2 | — |
| Daclizumab | Cytomegalovirus infection (22) | 3 (14) | — | 19 (86) | 48 (24–68) | 16 (73) | 4 (18) | 9 (3–44) | — |
| Tacrolimus | Coma (10) | 7 (70) | — | 2 (20) | 59 (46–75) | 4 (40) | 3 (30) | 2 (0–12) | 1 |
| Tremor (14) | 1 (7) | 1 (7) | 9 (64) | 49 (31–75) | 8 (57) | 6 (43) | 10 (0–42) | 1 | |
F: Female
*
Reported as median (minimum–maximum)
**
Percentages out of total number of reports including unknown sex values.