Table 1.
AEs in 15% or more of participants up to month 24
| ATG participants (n = 38) | Events | Placebo participants (n = 20) | Events | |
|---|---|---|---|---|
| Total number of events | 38 (100%) | 1148 | 20 (100%) | 415 |
| Grade 1 | 38 (100%) | 350 | 18 (90%) | 179 |
| Grade 2 | 37 (97%) | 604 | 18 (90%) | 200 |
| Grade 3 | 31 (82%) | 112 | 12 (60%) | 30 |
| Grade 4 | 38 (100%) | 78 | 4 (20%) | 5 |
| Grade 5 | 0 | 0 | 0 | 0 |
| Metabolism and nutrition disorders | 35 (92%) | 513 | 16 (80%) | 206 |
| Hypoglycaemia | 32 (84%) | 495 | 16 (80%) | 201 |
| Hyperglycaemia | 8 (21%) | 12 | 1 (5%) | 4 |
| Infections and infestations | 29 (76%) | 88 | 14 (70%) | 33 |
| Upper respiratory tract infection | 16 (42%) | 32 | 7 (35%) | 16 |
| Viral infection | 5 (13%) | 11 | 3 (15%) | 3 |
| Blood and lymphatic system disorders | 38 (100%) | 123 | 4 (20%) | 6 |
| CD4 lymphocytes decreased | 38 (100%) | 38 | 0 | 0 |
| Lymphopenia | 38 (100%) | 48 | 0 | 0 |
| Leucopenia | 14 (37%) | 20 | 0 | 0 |
| Neutropenia | 9 (24%) | 10 | 2 (10%) | 4 |
| Immune system disorders | 38 (100) | 84 | 3 (15%) | 3 |
| CRS | 37 (97%) | 37 | 1 (5%) | 1 |
| Serum sickness | 38 (100%) | 39 | 0 | 0 |
| Seasonal allergy | 7 (18%) | 8 | 2 (10%) | 2 |
| Skin and subcutaneous tissue disorders | 26 (68%) | 44 | 10 (50%) | 26 |
| Rash | 7 (18%) | 8 | 2 (10%) | 3 |
| Acne | 7 (18%) | 8 | 1 (5%) | 1 |
| Pruritus | 4 (11%) | 4 | 3 (15%) | 4 |
| Dermatitis contact | 2 (5%) | 2 | 3 (15%) | 3 |
| Gastrointestinal disorders | 24 (63%) | 51 | 11 (55%) | 20 |
| Nausea | 7 (18%) | 8 | 5 (25%) | 7 |
| Diarrhoea | 5 (13%) | 5 | 3 (15%) | 3 |
| Vomiting | 3 (8%) | 4 | 3 (15%) | 3 |
| Dyspepsia | 2 (5%) | 2 | 3 (15%) | 3 |
| Nervous system disorders | 24 (63%) | 41 | 11 (55%) | 23 |
| Headache | 18 (47%) | 25 | 10 (50%) | 15 |
| General disorders and administration site conditions | 26 (68%) | 36 | 8 (40%) | 18 |
| Fatigue | 3 (8%) | 4 | 4 (20%) | 5 |
| Pyrexia | 6 (16%) | 6 | 1 (5%) | 1 |
| Influenza like illness | 2 (5%) | 2 | 3 (15%) | 3 |
| Respiratory, thoracic and mediastinal disorders | 23 (61%) | 42 | 11 (55%) | 26 |
| Oropharyngeal pain | 9 (24%) | 13 | 5 (25%) | 6 |
| Cough | 8 (21%) | 10 | 4 (20%) | 5 |
| Nasal congestion | 3 (8%) | 4 | 3 (15%) | 4 |
| Rhinorrhoea | 1 (3%) | 1 | 3 (15%) | 3 |
| Musculoskeletal and connective tissue disorders | 14 (37%) | 26 | 11 (55%) | 20 |
| Back pain | 4 (11%) | 5 | 5 (25%) | 6 |
| Arthralgia | 4 (11%) | 4 | 3 (15%) | 4 |
| Musculoskeletal pain | 1 (3%) | 1 | 3 (15%) | 3 |
| Psychiatric disorders | 9 (24%) | 15 | 7 (35%) | 12 |
| Depression | 4 (11%) | 7 | 4 (20%) | 4 |
| Vascular disorders | 4 (11%) | 6 | 5 (25%) | 5 |
| Hypotension | 0 | 0 | 3 (15%) | 3 |