Table 2

Summary of safety results

FosdagrocoratPrednisonePlacebo
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)
Mild21 (46.7)20 (42.6)32 (71.1)18 (37.5)21 (46.7)30 (65.2)15 (31.9)
Moderate6 (13.3)7 (14.9)16 (35.6)14 (29.2)10 (22.2)14 (30.4)10 (21.3)
Severe03 (6.4)0005 (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 (%)01 (2.1)2 (4.4)2 (4.2)02 (4.3)2 (4.3)
Treatment-related, n (%)0000000
AEs of special interest2*3†01‡3§1¶2**
D/C3 (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)02 (4.3)3 (6.4)
Treatment-related, n (%)2 (4.4)4 (8.5)01 (2.1)01 (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.