Number of adverse events reported between 4 months and 1 year for patients in the early remission group, the randomisation arms and the outside protocol group
| Adverse events | Early remission (n=387) | Arm 1 (n=83) | Arm 2 (n=78) | Outside protocol (n=50) |
|---|---|---|---|---|
| Patients with AE*, no (%) | 205/387 (53) | 61/83 (74) | 52/78 (68) | 28/50 (56) |
| Total number of AE | 298 | 101 | 88 | 40 |
| Type of AE | ||||
| Cardiovascular | 9 | 5 | 6 | 1 |
| Pulmonary | 11 | – | 2 | 1 |
| Gastrointestinal | 62 | 18 | 20 | 8 |
| Nausea/emesis | 15 | 6 | 5 | 2 |
| Increased liver enzymes | 33 | 5 | 9 | 3 |
| Other | 14 | 7 | 6 | 3 |
| Neuropsychiatric | 22 | 17 | 2 | 4 |
| Headache | 2 | 7 | – | – |
| Dizziness | 10 | 1 | – | 2 |
| Mood disorders | 6 | 5 | 1 | – |
| Other | 4 | 4 | 1 | 2 |
| Urogenital | 5 | 2 | 2 | 1 |
| Skin/mucous membranes | 51 | 6 | 13 | 3 |
| Rash | 20 | 5 | 6 | 2 |
| Hair thinning/loss | 8 | 1 | 2 | 1 |
| Sicca complaints | 5 | – | 1 | – |
| Stomatitis | 4 | – | – | – |
| Other | 14 | – | 4 | – |
| Infections | 76 | 23 | 27 | 11 |
| Upper airway tract | 17 | 4 | 8 | 5 |
| Gastrointestinal | 4 | – | 3 | – |
| Skin/mucosa | 11 | 2 | 1 | 1 |
| Pneumonia/bronchitis | 8 | 3 | 1 | 1 |
| Urinary tract | 9 | 6 | 5 | 1 |
| Flu/unspecified fever | 10 | 2 | 2 | 2 |
| Other | 17 | 6 | 7 | 1 |
| Trauma/injury | 15 | 3 | – | 2 |
| Surgical procedures without hospitalisation | 9 | 3 | 2 | 2 |
| Other | 38 | 24 | 14 | 7 |
*One or more adverse events possible per patient.
AE, adverse event.