Table 2 Treatment-emergent adverse events
| Â | Placebo-controlled part Up to week 24 (SS1) | Extension part Week 24 to week 48 (SS2) | ||
|---|---|---|---|---|
HLX01 (n = 182) | Placebo (n = 92) | Continue HLX01 (n = 161) | Switch to HLX01 from placebo (n = 81) | |
Any TEAEs | 151 (83.0) | 74 (80.4) | 129 (80.1) | 68 (84.0) |
 Grade 1 or 2 | 132 (72.5) | 66 (71.7) | 115 (71.4) | 59 (72.8) |
 Grade 3 | 17 (9.3) | 8 (8.7) | 12 (7.5) | 9 (11.1) |
 Grade 4 | 2 (1.1) | 0 | 2 (1.2) | 0 |
Serious TEAEs | 12 (6.6) | 7 (7.6) | 9 (5.6) | 4 (4.9) |
TEAEs leading to treatment discontinuation | 13 (7.1) | 4 (4.3) | 1 (0.6) | 3 (3.7) |
ADRs | 100 (54.9) | 47 (51.1) | 86 (53.4) | 47 (58.0) |
IRRs | 22 (12.1) | 2 (2.2) | 8 (5.0) | 6 (7.4) |
Infections and infestations | 52 (28.6) | 24 (26.1) | 35 (21.7) | 11 (13.6) |
AESIs | 10 (5.5) | 2 (2.2) | 7 (4.3) | 5 (6.2) |
 IRRs (grade ≥3) | 1 (0.5) | 0 | 0 | 0 |
 Infections (grade ≥3) | 4 (2.2) | 2 (2.2) | 1 (0.6) | 2 (2.5) |
Most common TEAEsa | ||||
 Upper respiratory tract infection | 33 (18.1) | 17 (18.5) | 21 (13.0) | 10 (12.3) |
 Urinary tract infection | 20 (11.0) | 8 (8.7) | 16 (9.9) | 2 (2.5) |
 Anaemia | 13 (7.1) | 8 (8.7) | 6 (3.7) | 6 (7.4) |
 Hypertriglyceridemia | 12 (6.6) | 6 (6.5) | 13 (8.1) | 11 (13.6) |
 Liver dysfunction | 12 (6.6) | 6 (6.5) | 13 (8.1) | 3 (3.7) |
 Leukopenia | 10 (5.5) | 0 | 14 (8.7) | 6 (7.4) |
 Hypokalaemia | 10 (5.5) | 5 (5.4) | 8 (5.0) | 8 (9.9) |
 Lymphocyte count decreased | 14 (7.7) | 2 (2.2) | 14 (8.7) | 5 (6.2) |