Table 5.

Summary Incidence of Adverse Events and Adverse Drug Reactions

Summary	No. of patients (%)	No. of events
No. of patients in the safety set	130
AEs	28 (21.5)	43
Most frequent AEs by organ system (≥2% of all patients)
Gastrointestinal disorders	11 (8.5)	13
Infections and infestations	10 (7.6)	13
Respiratory, thoracic, and mediastinal disorders	3 (2.3)	3
ADRs by preferred term	6 (4.6)	9
Anemia	2 (1.5)	2
Abdominal pain*	1 (0.8)	1
Allergic rhinitis*	1 (0.8)	1
Anal hemorrhage*	1 (0.8)	1
Palpitation*	1 (0.8)	1
Pneumonia	1 (0.8)	1
Pyrexia	1 (0.8)	1
Tuberculosis	1 (0.8)	1

AEs, adverse events; ADRs, adverse drug reactions.

*Unexpected AEs.