Incidence of possibly treatment-related AEs by preferred term for AEs occurring in one or more MOR103-treated subjects
| 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 at least 1 possibly treatment-related AE* | 7 (25.9) | 3 (12.5) | 3 (13.6) | 4 (17.4) | 10 (14.5) |
| Fatigue | 0 (0.0) | 1 (4.2) | 1 (4.5) | 1 (4.3) | 3 (4.3) |
| Anaemia | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (8.7) | 2 (2.9) |
| Decreased DLco | 1 (3.7) | 2 (8.3) | 0 (0.0) | 0 (0.0) | 2 (2.9) |
| Nasopharyngitis | 2 (7.4) | 1 (4.2) | 0 (0.0) | 0 (0.0) | 1 (1.4) |
| Rash | 2 (7.4) | 1 (4.2) | 0 (0.0) | 0 (0.0) | 1 (1.4) |
| Decreased FEV1 | 0 (0.0) | 1 (4.2) | 0 (0.0) | 0 (0.0) | 1 (1.4) |
| Sinus tachycardia | 0 (0.0) | 1 (4.2) | 0 (0.0) | 0 (0.0) | 1 (1.4) |
| RA flare | 0 (0.0) | 0 (0.0) | 1 (4.5) | 0 (0.0) | 1 (1.4) |
| Nausea | 0 (0.0) | 0 (0.0) | 1 (4.5) | 0 (0.0) | 1 (1.4) |
| Oedema | 0 (0.0) | 0 (0.0) | 1 (4.5) | 0 (0.0) | 1 (1.4) |
| Hypertension | 0 (0.0) | 0 (0.0) | 1 (4.5) | 0 (0.0) | 1 (1.4) |
| Dermatitis | 0 (0.0) | 0 (0.0) | 1 (4.5) | 0 (0.0) | 1 (1.4) |
| Oral herpes | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (4.3) | 1 (1.4) |
| Rales | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (4.3) | 1 (1.4) |
| Presyncope | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (4.3) | 1 (1.4) |
Subjects could have more than one AE. Values shown are number (%) of subjects with events.
*14 AEs in placebo group; 7 in MOR103 0.3 mg/kg; 6 in MOR103 1.0 mg/kg; 6 in MOR103 1.5 mg/kg. Additional AEs in the placebo group that did not occur in a MOR103 subject and are not shown in the table were increased liver function tests (n=2) and one case each of pharyngitis, upper respiratory tract infection, urinary tract infection, flank pain, oropharyngeal pain, exertional dyspnoea and haematoma.
AE, adverse event; DLco, diffusing capacity of the lung for carbon monoxide; FEV1, forced expiratory volume in the first second; RA, rheumatoid arthritis.