Table 5.
Adverse events (including serious adverse events) leading to FAE treatment discontinuation
| Patients initiating FAE therapy, N | FAE monotherapy 626 | FAEs + phototherapy 123 | FAEs + MTX 110 | All 859 | ||||
|---|---|---|---|---|---|---|---|---|
| At least one AE | FAE discontinuation | At least one AE | FAE discontinuation | At least one AE | FAE discontinuation | At least one AE | FAE discontinuation | |
| Total patients, n (% of N ) | 307 (49.0) | 82 (13.1) | 62 (50.4) | 14 (11.4) | 52 (47.3) | 15 (13.6) | 421 (49.0) | 111 (12.9) |
| AE, n (% of N ) | Total observeda | FAE discontinuation | Total observeda | FAE discontinuation | Total observeda | FAE discontinuation | Total observeda | FAE discontinuation |
| Gastrointestinal disorders | 187 (29.9) | 32 (5.1) | 46 (37.4) | 5 (4.1) | 36 (32.7) | 4 (3.6) | 269 (31.3) | 41 (4.8) |
| Flush/hot flushes | 86 (13.7) | 5 (0.8) | 7 (5.7) | 0 | 13 (11.8) | 1 (0.9) | 106 (12.3) | 6 (0.7) |
| Blood and lymphatic system disorders | 41 (6.5) | 27 (4.3) | 7 (5.7) | 6 (4.9) | 10 (9.1) | 7 (6.4) | 58 (6.8) | 40 (4.7) |
| Skin and subcutaneous tissue disorders | 35 (5.6) | 2 (0.3) | 8 (6.5) | 0 | 5 (4.5) | 0 | 48 (5.6) | 2 (0.2) |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 13 (2.1) | 1 (0.2) | 2 (1.6) | 0 | 1 (0.9) | 0 | 16 (1.9) | 1 (0.1) |
| Hepatobiliary disorders | 9 (1.4) | 6 (1.0) | 3 (2.4) | 1 (0.8) | 3 (2.7) | 3 (2.7) | 15 (1.7) | 10 (1.2) |
| Renal and urinary disorders | 10 (1.6) | 4 (0.6) | 3 (2.4) | 1 (0.8) | 0 | 0 | 13 (1.5) | 5 (0.6) |
| Infections and infestations | 3 (0.5) | 0 | 0 | 0 | 4 (3.6) | 0 | 7 (0.8) | 0 |
| Metabolism and nutrition disorders | 1 (0.2) | 0 | 3 (2.4) | 1 (0.8) | 2 (1.8) | 0 | 6 (0.7) | 1 (0.1) |
| Others | 4 (0.6) | 2 (0.3) | 0 | 0 | 0 | 0 | 4 (0.5) | 2 (0.2) |
| Respiratory, thoracic and mediastinal disorders | 4 (0.6) | 1 (0.2) | 0 | 0 | 0 | 0 | 4 (0.5) | 1 (0.1) |
| Vascular disorders | 3 (0.5) | 0 | 0 | 0 | 1 (0.9) | 0 | 4 (0.5) | 0 |
| Nervous system disorders | 2 (0.3) | 1 (0.2) | 0 | 0 | 1 (0.9) | 0 | 3 (0.3) | 1 (0.1) |
| Psychiatric disorders | 2 (0.3) | 0 | 0 | 0 | 1 (0.9) | 0 | 3 (0.3) | 0 |
| Musculoskeletal and connective tissue disorders | 1 (0.2) | 0 | 1 (0.8) | 0 | 0 | 0 | 2 (0.2) | 0 |
| Cardiac disorders | 0 | 0 | 2 (1.6) | 0 | 0 | 0 | 2 (0.2) | 0 |
| Surgical and medical procedures | 2 (0.3) | 0 | 0 | 0 | 0 | 0 | 2 (0.2) | 0 |
| Reproductive system and breast disorders | 1 (0.2) | 1 (0.2) | 0 | 0 | 0 | 0 | 1 (0.1) | 1 (0.1) |
| Ear and labyrinth disorders | 0 | 0 | 1 (0.8) | 0 | 0 | 0 | 1 (0.1) | 0 |
| General disorders and administration site conditions | 1 (0.2) | 0 | 0 | 0 | 0 | 0 | 1 (0.1) | 0 |
| Injury, poisoning and procedural complications | 1 (0.2) | 0 | 0 | 0 | 0 | 0 | 1 (0.1) | 0 |
a
Multiple AEs possible. AE terminology based on MedDRA (Medical Dictionary for Regulatory Activities) system organ classification version 20.1 September 2017.
FAEs, fumaric acid esters; phototherapy, ultraviolet A, ultraviolet B or psoralen + ultraviolet A; MTX, methotrexate; AE, adverse event. Others included pruritus and vertigo.