Table 2

Incidence of treatment-emergent adverse events occurring in >2 subjects in any treatment group

Adverse eventPlacebo
(N=27)
MOR103
0.3 mg/kg
(N=24)
1.0 mg/kg
(N=22)
1.5 mg/kg
(N=23)
Pooled active
(N=69)
Subjects with any treatment-emergent AE12 (44.4)13 (54.2)14 (63.6)15 (65.2)42 (60.9)
Nasopharyngitis3 (11.1)1 (4.2)7 (31.8)1 (4.3)9 (13.0)
RA*0 (0.0)3 (12.5)4 (18.2)2 (8.7)9 (13.0)
Fatigue1 (3.7)1 (4.2)4 (18.2)1 (4.3)6 (8.7)
Hypertension1 (3.7)1 (4.2)2 (9.1)2 (8.7)5 (7.2)
Headache1 (3.7)1 (4.2)0 (0.0)2 (8.7)3 (4.3)
Cough0 (0.0)1 (4.2)0 (0.0)2 (9.7)3 (4.3)
Anaemia0 (0.0)0 (0.0)0 (0.0)2 (8.7)2 (2.9)
Decreased DLco2 (7.4)2 (8.3)0 (0.0)0 (0.0)2 (2.9)
Oropharyngeal pain1 (3.7)0 (0.0)2 (9.1)0 (0.0)2 (2.9)
Rhinitis0 (0.0)0 (0.0)2 (9.1)0 (0.0)2 (2.9)
Rhinorrhoea0 (0.0)0 (0.0)0 (0.0)2 (8.7)2 (2.9)
Viral respiratory tract infection0 (0.0)0 (0.0)0 (0.0)2 (8.7)2 (2.9)
Peripheral oedema2 (7.4)0 (0.0)1 (4.5)0 (0.0)1 (1.4)
Rash3 (11.1)1 (4.2)0 (0.0)0 (0.0)1 (1.4)
Upper respiratory tract infection2 (7.4)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
Urinary tract infection3 (11.1)0 (0.0)0 (0.0)0 (0.0)0 (0.0)
  • Values shown are number (%) of subjects with events.

  • *Worsening or exacerbation of existing RA (flares). Except for one patient in the MOR103 0.3 mg/kg group (date of flare not reported), all events occurred from 10 days to >12 weeks following the last dose of active treatment.

  • AE, adverse event; DLco, diffusing capacity of the lung for carbon monoxide; RA, rheumatoid arthritis.