Table 2.
Incidence of treatment-emergent adverse events occurring in >2 subjects in any treatment group
| Adverse event | Placebo (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 AE | 12 (44.4) | 13 (54.2) | 14 (63.6) | 15 (65.2) | 42 (60.9) |
| Nasopharyngitis | 3 (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) |
| Fatigue | 1 (3.7) | 1 (4.2) | 4 (18.2) | 1 (4.3) | 6 (8.7) |
| Hypertension | 1 (3.7) | 1 (4.2) | 2 (9.1) | 2 (8.7) | 5 (7.2) |
| Headache | 1 (3.7) | 1 (4.2) | 0 (0.0) | 2 (8.7) | 3 (4.3) |
| Cough | 0 (0.0) | 1 (4.2) | 0 (0.0) | 2 (9.7) | 3 (4.3) |
| Anaemia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (8.7) | 2 (2.9) |
| Decreased DLco | 2 (7.4) | 2 (8.3) | 0 (0.0) | 0 (0.0) | 2 (2.9) |
| Oropharyngeal pain | 1 (3.7) | 0 (0.0) | 2 (9.1) | 0 (0.0) | 2 (2.9) |
| Rhinitis | 0 (0.0) | 0 (0.0) | 2 (9.1) | 0 (0.0) | 2 (2.9) |
| Rhinorrhoea | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (8.7) | 2 (2.9) |
| Viral respiratory tract infection | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (8.7) | 2 (2.9) |
| Peripheral oedema | 2 (7.4) | 0 (0.0) | 1 (4.5) | 0 (0.0) | 1 (1.4) |
| Rash | 3 (11.1) | 1 (4.2) | 0 (0.0) | 0 (0.0) | 1 (1.4) |
| Upper respiratory tract infection | 2 (7.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Urinary tract infection | 3 (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.