Table 3

Safety overview: most frequent TEAEs (occurring in ≥5% of patients in any group)

Adverse eventPlacebo
(N=35)
Tabalumab
30 mg
(N=35)
80 mg
(N=30)
Death000
SAEs3 (8.6)02 (6.7)
Discontinued due to AE01 (2.9)1 (3.3)
TEAEs25 (71.4)23 (65.7)23 (76.7)
RA (worsening/flare)9 (25.7)4 (11.4)3 (10.0)
Headache2 (5.7)1 (2.9)3 (10.0)
Upper respiratory tract infection02 (5.7)3 (10.0)
Anaemia003 (10.0)
Abdominal pain (upper)02 (5.7)2 (6.7)
Intervertebral disc protrusion002 (6.7)
Nausea002 (6.7)
Hypertension2 (5.7)2 (5.7)1 (3.3)
Bursitis02 (5.7)1 (3.3)
Pyrexia02 (5.7)1 (3.3)
Nasopharyngitis2 (5.7)3 (8.6)0
Hypokalaemia2 (5.7)1 (2.9)0
Rhinitis2 (5.7)1 (2.9)0
Alopecia02 (5.7)0
Rash papular02 (5.7)0
Sinusitis02 (5.7)0
  • Values are number (%) of patients.

  • AE, adverse event; RA, rheumatoid arthritis; SAE, serious adverse event; TEAE, treatment-emergent adverse event.