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 |