Table 3.
Number of adverse events reported between 1 year and 2 years
| Early remission n = 387 | Arm 1 n = 83 | Arm 2 n = 78 | OOP n = 50 | |
|---|---|---|---|---|
| Patients with AE*, n (%) | 205/387 (53 %) | 53/83 (64 %) | 52/78 (67 %) | 27/50 (54 %) |
| Total number of AE | 408 | 129 | 109 | 58 |
| Cardiovascular | 25 | 5 | 8 | 4 |
| Pulmonary | 17 | 5 | 2 | 2 |
| Gastrointestinal | 67 | 16 | 14 | 12 |
| GI complaints | 8 | 2 | 2 | – |
| Nausea/emesis | 23 | 2 | 4 | 4 |
| Increased liver enzymes | 15 | 7 | 3 | 4 |
| Other | 21 | 5 | 5 | 4 |
| Neuro-psychiatric | 37 | 5 | 7 | 3 |
| Headache | 14 | – | 4 | 1 |
| Dizziness | 7 | 1 | – | 1 |
| Mood disorders | 4 | – | – | 1 |
| Other | 12 | 4 | 3 | – |
| Urogenital | 7 | 3 | 2 | 3 |
| Skin/mucous membranes | 45 | 18 | 15 | 3 |
| Rash | 19 | 8 | 5 | – |
| Hair loss/thinning | 4 | 1 | 1 | 1 |
| Sicca complaints | 3 | – | – | 1 |
| Eczema | 3 | 1 | – | – |
| Other | 16 | 8 | 9 | 1 |
| Infections | 106 | 38 | 41 | 18 |
| Upper airway tract | 29 | 11 | 16 | 10 |
| Gastrointestinal | 4 | 1 | – | 2 |
| Skin/mucosa | 14 | 2 | 4 | 2 |
| Pneumonia/bronchitis | 9 | 1 | 1 | 1 |
| Urinary tract | 15 | 7 | 5 | 1 |
| Influenza/unspecified fever | 25 | 10 | 6 | 1 |
| Other | 10 | 6 | 9 | 1 |
| Trauma/injury | 13 | 5 | 2 | 3 |
| Infusion reaction | 3 | 1 | – | – |
| Malaise | 9 | 5 | 1 | 1 |
| Surgical procedures without hospitalization | 13 | 5 | 4 | 1 |
| Other | 65 | 23 | 12 | 8 |
*One or more adverse events possible per patient. OOP outside of protocol, AE adverse events, GI gastrointestinal