Table 3 Common treatment-emergent adverse events (Safety Seta).
Placebo (N = 62) | Palovarotene 2.5 mg (N = 66) | Palovarotene 5.0 mg (N = 65) | All palovarotene-treated patients (N = 131) | All patients (N = 193) | |
|---|---|---|---|---|---|
Patients with any TEAE, n (%) | 41 (66.1) | 56 (84.8) | 56 (86.2) | 112 (85.5) | 153 (79.3) |
Skin and subcutaneous tissue disorders, n (%) | 21 (33.9) | 43 (65.2) | 51 (78.5) | 94 (71.8) | 115 (59.6) |
Rash | 7 (11.3) | 17 (25.8) | 25 (38.5) | 42 (32.1) | 49 (25.4) |
Dry skin | 7 (11.3) | 16 (24.2) | 19 (29.2) | 35 (26.7) | 42 (21.8) |
Pruritus | 6 (9.7) | 8 (12.1) | 7 (10.8) | 15 (11.5) | 21 (10.9) |
Rash generalized | 2 (3.2) | 3 (4.5) | 5 (7.7) | 8 (6.1) | 10 (5.2) |
Gastrointestinal disorders, n (%) | 12 (19.4) | 24 (36.4) | 23 (35.4) | 47 (35.9) | 59 (30.6) |
Lip dryness | 3 (4.8) | 6 (9.1) | 11 (16.9) | 17 (13.0) | 20 (10.4) |
Vomiting | 2 (3.2) | 3 (4.5) | 7 (10.8) | 10 (7.6) | 12 (6.2) |
Dry mouth | 3 (4.8) | 4 (6.1) | 4 (6.2) | 8 (6.1) | 11 (5.7) |
Infections and infestations, n (%) | 14 (22.6) | 20 (30.3) | 20 (30.8) | 40 (30.5) | 54 (28.0) |
Nasopharyngitis | 3 (4.8) | 3 (4.5) | 5 (7.7) | 8 (6.1) | 11 (5.7) |
Musculoskeletal and connective tissue disorders, n (%) | 10 (16.1) | 6 (9.1) | 9 (13.8) | 15 (11.5) | 25 (13.0) |
Arthralgia | 7 (11.3) | 3 (4.5) | 1 (1.5) | 4 (3.1) | 11 (5.7) |
General disorders and administration site conditions, n (%) | 2 (3.2) | 8 (12.1) | 10 (15.4) | 18 (13.7) | 20 (10.4) |
Pyrexia | 0 | 3 (4.5) | 9 (13.8) | 12 (9.2) | 12 (6.2) |
Nervous system disorders, n (%) | 8 (12.9) | 5 (7.6) | 6 (9.2) | 11 (8.4) | 19 (9.8) |
Headache | 6 (9.7) | 4 (6.1) | 3 (4.6) | 7 (5.3) | 13 (6.7) |
