Table 2.
GX-19 1·5 mg group (n=20) | GX-19 3·0 mg group (n=20) | GX-19N 3·0 mg group (n=21) | |
---|---|---|---|
Participants with treatment-emergent adverse events | 12 (60%) | 8 (40%) | 12 (57%) |
General disorders and administration site conditions | 11 (55%) | 4 (20%) | 6 (29%) |
Chills | 0 | 0 | 1 (5%) |
Fatigue | 3 (15%) | 0 | 0 |
Injection site erythema | 2 (10%) | 0 | 1 (5%) |
Injection site oedema | 1 (5%) | 0 | 0 |
Injection site pain | 6 (30%) | 3 (15%) | 6 (29%) |
Injection site pruritus | 5 (25%) | 2 (10%) | 0 |
Nervous system disorders | 4 (20%) | 0 | 2 (10%) |
Cubital tunnel syndrome | 0 | 0 | 1 (5%) |
Headache | 3 (15%) | 0 | 1 (5%) |
Paresthesia | 1 (5%) | 0 | 0 |
Musculoskeletal and connective tissue disorders | 1 (5%) | 1 (5%) | 2 (10%) |
Back pain | 0 | 0 | 1 (5%) |
Myalgia | 1 (5%) | 0 | 1 (5%) |
Rotator cuff syndrome | 0 | 1 (5%) | 0 |
Somatic dysfunction | 0 | 1 (5%) | 0 |
Gastrointestinal disorders | 2 (10%) | 1 (5%) | 0 |
Dyspepsia | 1 (5%) | 0 | 0 |
Haematochezia | 1 (5%) | 0 | 0 |
Stomatitis | 0 | 1 (5%) | 0 |
Skin and subcutaneous tissue disorders | 0 | 1 (5%) | 3 (14%) |
Dermatitis | 0 | 1 (5%) | 0 |
Pruritus | 0 | 0 | 1 (5%) |
Rash | 0 | 0 | 2 (10%) |
Urticaria | 0 | 0 | 1 (5%) |
Infections and infestations | 0 | 2 (10%) | 1 (5%) |
Appendicitis | 0 | 1 (5%) | 0 |
Folliculitis | 0 | 0 | 1 (5%) |
Vaginal infection | 0 | 1 (5%) | 0 |
Investigations | 0 | 0 | 1 (5%) |
Alanine aminotransferase increased | 0 | 0 | 1 (5%) |
Aspartate aminotransferase increased | 0 | 0 | 1 (5%) |
Reproductive system and breast disorders | 0 | 2 (10%) | 1 (5%) |
Dysmenorrhoea | 0 | 1 (5%) | 1 (5%) |
Premenstrual syndrome | 0 | 1 (5%) | 0 |
Hepatobiliary disorders | 0 | 0 | 1 (5%) |
Cholecystitis acute | 0 | 0 | 1 (5%) |
Psychiatric disorders | 1 (5%) | 0 | 0 |
Depression | 1 (5%) | 0 | 0 |
Eye disorders | 1 (5%) | 1 (5%) | 0 |
Blepharospasm | 0 | 1 (5%) | 0 |
Visual impairment | 1 (5%) | 0 | 0 |
Adverse events defined according to Medical Dictionary for Regulatory Activities (version 24.0).