Table 2

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 eventsEarly 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 AE2981018840
Type of AE
Cardiovascular9561
Pulmonary1121
Gastrointestinal6218208
 Nausea/emesis15652
 Increased liver enzymes33593
 Other14763
Neuropsychiatric221724
 Headache27
 Dizziness1012
 Mood disorders651
 Other4412
Urogenital5221
Skin/mucous membranes516133
 Rash20562
 Hair thinning/loss8121
 Sicca complaints51
 Stomatitis4
 Other144
Infections76232711
 Upper airway tract17485
 Gastrointestinal43
 Skin/mucosa11211
 Pneumonia/bronchitis8311
 Urinary tract9651
 Flu/unspecified fever10222
 Other17671
Trauma/injury1532
Surgical procedures without hospitalisation9322
Other3824147
  • *One or more adverse events possible per patient.

  • AE, adverse event.