Table 2.
All AEs (including infections) reported in ≥5 % of subjects during IGHy treatment (including ramp-up)
| AEs | By subject N = 83 | By subject-year N = 187.69 | By infusion N = 2959 | ||
|---|---|---|---|---|---|
| System organ class | Preferred term | n | n (%) | n (rate)a | n (%)b |
| Blood and lymphatic system disorders | Lymphadenopathy | 14 | 10 (12.0 %) | 14 (0.07) | 14 (0.47 %) |
| Cardiac disorders | Tachycardia | 10 | 8 (9.6 %) | 10 (0.05) | 10 (0.34 %) |
| Gastrointestinal disorders | Nausea | 74 | 27 (32.5 %) | 74 (0.39) | 70 (2.37 %) |
| Vomiting | 38 | 24 (28.9 %) | 38 (0.20) | 38 (1.28 %) | |
| Diarrhea | 34 | 20 (24.1 %) | 34 (0.18) | 33 (1.12 %) | |
| Upper abdominal pain | 19 | 12 (14.5 %) | 19 (0.10) | 19 (0.64 %) | |
| Abdominal pain | 17 | 10 (12.0 %) | 17 (0.09) | 14 (0.47 %) | |
| Constipation | 9 | 9 (10.8 %) | 9 (0.05) | 9 (0.30 %) | |
| Gastroesophageal reflux disease | 6 | 6 (7.2 %) | 6 (0.03) | 6 (0.20 %) | |
| Aphthous stomatitis | 9 | 5 (6.0 %) | 9 (0.05) | 9 (0.30 %) | |
| Dental caries | 7 | 5 (6.0 %) | 7 (0.04) | 7 (0.24 %) | |
| Hemorrhoids | 6 | 5 (6.0 %) | 6 (0.03) | 6 (0.20 %) | |
| General disorders and administrative site conditions | Infusion site pain | 213 | 44 (53.0 %) | 213 (1.13) | 202 (6.83 %) |
| Fatigue | 52 | 22 (26.5 %) | 52 (0.28) | 51 (1.72 %) | |
| Infusion site erythema | 70 | 21 (25.3 %) | 70 (0.37) | 70 (2.37 %) | |
| Pyrexia | 42 | 21 (25.3 %) | 42 (0.22) | 40 (1.35 %) | |
| Infusion site discomfort | 41 | 11 (13.3 %) | 41 (0.22) | 39 (1.32 %) | |
| Pain | 22 | 11 (13.3 %) | 22 (0.12) | 22 (0.74 %) | |
| Infusion site pruritus | 52 | 8 (9.6 %) | 52 (0.28) | 51 (1.72 %) | |
| Infusion site swelling | 17 | 8 (9.6 %) | 17 (0.09) | 15 (0.51 %) | |
| Asthenia | 20 | 7 (8.4 %) | 20 (0.11) | 19 (0.64 %) | |
| Infusion site edema | 17 | 7 (8.4 %) | 17 (0.09) | 17 (0.57 %) | |
| Local swelling | 9 | 7 (8.4 %) | 9 (0.05) | 9 (0.30 %) | |
| Peripheral edema | 15 | 7 (8.4 %) | 15 (0.08) | 14 (0.47 %) | |
| Chest pain | 5 | 5 (6.0 %) | 5 (0.03) | 5 (0.17 %) | |
| Infections and infestations | Sinusitis | 122 | 47 (56.6 %) | 122 (0.65) | 122 (4.12 %) |
| Upper respiratory tract infection | 78 | 41 (49.4 %) | 78 (0.42) | 74 (2.50 %) | |
| Viral upper respiratory tract infection | 41 | 18 (21.7 %) | 41 (0.22) | 41 (1.39 %) | |
| Bronchitis | 34 | 17 (20.5 %) | 34 (0.18) | 34 (1.15 %) | |
| Viral gastroenteritis | 19 | 15 (18.1 %) | 19 (0.10) | 19 (0.64 %) | |
| Viral infection | 13 | 12 (14.5 %) | 13 (0.07) | 13 (0.44 %) | |
| Influenza | 13 | 11 (13.3 %) | 13 (0.07) | 13 (0.44 %) | |
| Nasopharyngitis | 18 | 11 (13.3 %) | 18 (0.10) | 18 (0.61 %) | |
| Chronic sinusitis | 14 | 10 (12.0 %) | 14 (0.07) | 14 (0.47 %) | |
| Gastroenteritis | 11 | 10 (12.0 %) | 11 (0.06) | 11 (0.37 %) | |
| Urinary tract infection | 17 | 10 (12.0 %) | 17 (0.09) | 17 (0.57 %) | |
| Cellulitis | 9 | 9 (10.8 %) | 9 (0.05) | 9 (0.30 %) | |
| Oral herpes | 10 | 8 (9.6 %) | 10 (0.05) | 10 (0.34 %) | |
| Pharyngitis | 10 | 8 (9.6 %) | 10 (0.05) | 10 (0.34 %) | |
| Post procedural infection | 7 | 7 (8.4 %) | 7 (0.04) | 7 (0.24 %) | |
| Ear infection | 8 | 6 (7.2 %) | 8 (0.04) | 7 (0.24 %) | |
| Acute sinusitis | 6 | 5 (6.0 %) | 6 (0.03) | 6 (0.20 %) | |
| Pneumonia | 5 | 5 (6.0 %) | 5 (0.03) | 5 (0.17 %) | |
| Respiratory tract infection | 6 | 5 (6.0 %) | 6 (0.03) | 5 (0.17 %) | |
| Injury, poisoning, and procedural complications | Procedural pain | 14 | 12 (14.5 %) | 14 (0.07) | 14 (0.47 %) |
| Excoriation | 12 | 10 (12.0 %) | 12 (0.06) | 11 (0.37 %) | |
| Contusion | 8 | 6 (7.2 %) | 8 (0.04) | 8 (0.27 %) | |
| Metabolism and nutrition disorders | Vitamin D deficiency | 5 | 5 (6.0 %) | 5 (0.03) | 5 (0.17 %) |
| Musculoskeletal and connective tissue disorders | Arthralgia | 24 | 16 (19.3 %) | 24 (0.13) | 24 (0.81 %) |
| Myalgia | 49 | 12 (14.5 %) | 49 (0.26) | 49 (1.66 %) | |
| Back pain | 14 | 11 (13.3 %) | 14 (0.07) | 14 (0.47 %) | |
| Pain in extremity | 13 | 8 (9.6 %) | 13 (0.07) | 10 (0.34 %) | |
| Nervous system disorders | Headache | 111 | 45 (54.2 %) | 111 (0.59) | 104 (3.51 %) |
| Dizziness | 25 | 14 (16.9 %) | 25 (0.13) | 24 (0.81 %) | |
| Migraine | 23 | 10 (12.0 %) | 23 (0.12) | 19 (0.64 %) | |
| Psychiatric disorders | Anxiety | 9 | 8 (9.6 %) | 9 (0.05) | 9 (0.30 %) |
| Insomnia | 6 | 6 (7.2 %) | 6 (0.03) | 6 (0.20 %) | |
| Depression | 5 | 5 (6.0 %) | 5 (0.03) | 5 (0.17 %) | |
| Respiratory, thoracic, and mediastinal disorders | Asthma | 60 | 24 (28.9 %) | 60 (0.32) | 56 (1.89 %) |
| Cough | 22 | 16 (19.3 %) | 22 (0.12) | 21 (0.71 %) | |
| Nasal congestion | 23 | 11 (13.3 %) | 23 (0.12) | 23 (0.78 %) | |
| Oropharyngeal pain | 11 | 8 (9.6 %) | 11 (0.06) | 11 (0.37 %) | |
| Epistaxis | 17 | 6 (7.2 %) | 17 (0.09) | 15 (0.51 %) | |
| Allergic rhinitis | 6 | 5 (6.0 %) | 6 (0.03) | 5 (0.17 %) | |
| Skin and subcutaneous tissue disorders | Contact dermatitis | 10 | 8 (9.6 %) | 10 (0.05) | 10 (0.34 %) |
| Rash | 8 | 8 (9.6 %) | 8 (0.04) | 8 (0.27 %) | |
| Erythema | 7 | 6 (7.2 %) | 7 (0.04) | 7 (0.24 %) | |
| Urticaria | 6 | 6 (7.2 %) | 6 (0.03) | 6 (0.20 %) | |
| Pruritus | 6 | 5 (6.0 %) | 6 (0.03) | 6 (0.20 %) | |
| Vascular disorders | Hypertension | 16 | 12 (14.5 %) | 16 (0.09) | 14 (0.47 %) |
aTotal number of AEs divided by the total number of subject-years while on IGSC with rHuPH20 treatment
bNumber of infusions associated with an AE divided by the total number of infusions and presented as a percent (i.e., multiplied by 100)