Table 2 Integrated summary of TEAEs and most common TEAEs across Periods I and II
FKB327 | RP | |
|---|---|---|
n = 474 | n = 470 | |
n (%)* | n (%)* | |
Summary of TEAEs | ||
Patients with at least one TEAE | 295 (62.2) | 311 (66.2) |
Patients with at least one severe TEAE | 17 (3.6) | 12 (2.6) |
Patients with at least one treatment-related TEAE | 122 (25.7) | 132 (28.1) |
Patients with TEAE leading to treatment discontinuation | 28 (5.9) | 21 (4.5) |
Patients with TEAE leading to treatment interruption | 56 (11.8) | 62 (13.2) |
Patients with at least one TESAE | 25 (5.3) | 34 (7.2) |
Deaths | 2 (0.4) | 1 (0.2) |
Most common TEAEs (≥ 3% of patients in any group)† | ||
Blood and lymphatic system disorders | 26 (5.5) | 25 (5.3) |
Anemia | 14 (3.0) | 13 (2.8) |
Gastrointestinal disorders | 48 (10.1) | 55 (11.7) |
Diarrhea | 12 (2.5) | 18 (3.8) |
General disorders and administration site conditions | 27 (5.7) | 32 (6.8) |
Infections and infestations | 151 (31.9) | 170 (36.2) |
Nasopharyngitis | 36 (7.6) | 46 (9.8) |
Upper respiratory tract infection | 18 (3.8) | 26 (5.5) |
Bronchitis | 16 (3.4) | 27 (5.7) |
Urinary tract infection | 24 (5.1) | 17 (3.6) |
Pharyngitis | 14 (3.0) | 15 (3.2) |
Latent tuberculosis | 15 (3.2) | 8 (1.7) |
Injury, poisoning and procedural complications | 27 (5.7) | 31 (6.6) |
Investigations | 54 (11.4) | 40 (8.5) |
Metabolism and nutrition disorders | 39 (8.2) | 35 (7.4) |
Hypercholesterolemia | 20 (4.2) | 16 (3.4) |
Musculoskeletal and connective tissue disorders | 67 (14.1) | 65 (13.8) |
RA | 26 (5.5) | 23 (4.9) |
Nervous system disorders | 29 (6.1) | 34 (7.2) |
Renal and urinary disorders | 23 (4.9) | 23 (4.9) |
Respiratory, thoracic, and mediastinal disorders | 21 (4.4) | 20 (4.3) |
Skin and subcutaneous tissue disorders | 40 (8.4) | 36 (7.7) |
Vascular disorders | 23 (4.9) | 27 (5.7) |
Hypertension | 12 (2.5) | 21 (4.5) |