Table 2.
Summary of safety results
| Fosdagrocorat | Prednisone | Placebo | |||||
| 1 mg (n=45) |
5 mg (n=47) |
10 mg (n=45) |
15 mg (n=48) |
5 mg (n=45) |
10 mg (n=46) |
(n=47) | |
| TEAEs, n (%) | 20 (44.4) | 19 (40.4) | 22 (48.9) | 18 (37.5) | 16 (35.6) | 19 (41.3) | 17 (36.2) |
| Mild | 21 (46.7) | 20 (42.6) | 32 (71.1) | 18 (37.5) | 21 (46.7) | 30 (65.2) | 15 (31.9) |
| Moderate | 6 (13.3) | 7 (14.9) | 16 (35.6) | 14 (29.2) | 10 (22.2) | 14 (30.4) | 10 (21.3) |
| Severe | 0 | 3 (6.4) | 0 | 0 | 0 | 5 (10.9) | 3 (6.4) |
| Treatment-related, n (%) | 12 (26.7) | 8 (17.0) | 9 (20.0) | 7 (14.6) | 7 (15.6) | 10 (21.7) | 10 (21.3) |
| SAEs, n (%) | 0 | 1 (2.1) | 2 (4.4) | 2 (4.2) | 0 | 2 (4.3) | 2 (4.3) |
| Treatment-related, n (%) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AEs of special interest | 2* | 3† | 0 | 1‡ | 3§ | 1¶ | 2** |
| D/C | 3 (6.7) | 7 (14.9) | 1 (2.2) | 5 (10.4) | 1 (2.2) | 2 (4.3) | 8 (17.0) |
| D/C due to AEs, n (%) | 2 (4.4) | 4 (8.5) | 1 (2.2) | 2 (4.2) | 0 | 2 (4.3) | 3 (6.4) |
| Treatment-related, n (%) | 2 (4.4) | 4 (8.5) | 0 | 1 (2.1) | 0 | 1 (2.2) | 1 (2.1) |
All study treatments were administered once daily.
Six patients had dose reduction or were temporarily discontinued due to an AE (1 [2.2%] with fosdagrocorat 1 mg, 1 [2.1%] with fosdagrocorat 5 mg, 1 [2.2%] with fosdagrocorat 10 mg and 3 [6.4%] with placebo); three were considered treatment-related (1 [2.2%] with fosdagrocorat 1 mg and 2 [4.3%] with placebo).
*Fatigue (n=1) and neutropaenia (n=1): neutropaenia was mild to moderate and related to study drug; no action was taken with regard to study drug and both events resolved.
†Hypertension (n=3).
‡Hypertension (n=1): treatment-related leading to discontinuation after one dose of study drug.
§Insomnia (n=1) and hypertension (1 patient; 2 events).
¶Dyslipidaemia (n=1).
**Dyslipidaemia (n=1) and neutropaenia (n=1): neutropaenia was mild and related to study drug; no action was taken with regard to study drug and both events resolved.
AE, adverse event;D/C, discontinuation;n, number of patients;SAE, serious adverse event;TEAE, treatment-emergent adverse event.