Table 1 Number and percentage of subjects experiencing study drug related adverse events in the FIH study
From: Single low-dose rHuIL-12 safely triggers multilineage hematopoietic and immune-mediated effects
System organ class/preferred term | Placebo | rHuIL-12 | rHuIL-12 | rHuIL-12 | rHuIL-12 | rHuIL-12 | rHuIL-12 |
|---|---|---|---|---|---|---|---|
2 μg | 5 μg | 10 μg | 12 μg | 15 μg | 20 μg | ||
(N = 11) | (N = 4) | (N = 4) | (N = 4) | (N = 4) | (N = 4) | (N = 1) | |
| Â | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) |
Blood and Lymphatic System Disorders | Â | Â | Â | Â | Â | Â | Â |
  Leukopenia |  |  |  |  |  |  | 1 (100%) |
  Lymphopenia | - | - | - | - | - | - | 1 (100%) |
  Neutropenia | - | - | - | - | - | 1 (25%) |  |
  Thrombocytopenia | - | - | - | - | - | - | 1 (100%) |
Gastrointestinal Disorders | Â | Â | Â | Â | Â | Â | Â |
  Abdominal Distension | - | - | - | - | 1 (25%) | - | - |
  Dyspepsia | - | - | - | - | 1 (25%) | - | - |
  Nausea | - | - | - | - | - | - | 1 (100%) |
  Paraesthesia Oral | - | - | - | - | 1 (25%) | - | - |
General Disorders and Administration Site Conditions | Â | Â | Â | Â | Â | Â | Â |
  Chills | - | - | - | - | 1 (25%) | 1 (25%) | 1 (100%) |
  Fatigue | - | - | - | - | - | 1 (25%) | - |
  Feeling Abnormal | - | 1 (25%) | - | - | - | - | - |
  Feeling Hot | - | - | - | - | - | - | 1 (100%) |
  Injection Site Erythema | 2 (18%) |  | - | - | - | 1 (25%) | 1 (100%) |
  Injection Site Hemorrhage | 1 (9%) |  |  |  |  |  |  |
  Injection Site Pain | 1 (9%) |  |  |  | 1 (25%) | 1 (25%) |  |
Injection Site Reaction | 1 (9%) | - | - | - | 1 (25%) | - | - |
  Local Swelling | - | - | - | - | 1 (25%) | - | - |
  Malaise | - | - | - | - | - | - | 1 (100%) |
  Pain | - | - | - | - | 1 (25%) | - | - |
  Infections and Infestations |  |  |  |  |  |  |  |
  Viral Infection | - | - | 1 (25%) | 1 (25%) | - | - | - |
  Tonsillitis | - | 1 (25%) | - | - | - | - | - |
Musculoskeletal and Connective Tissue Disorders | Â | Â | Â | Â | Â | Â | Â |
  Back Pain |  | - | - | - |  | 1 (25%) | - |
  Myalgia | - | - | 1 (25%) | - | - | 1 (25%) | -- |
  Musculoskeletal Pain | 1 (9%) | - | - | - | - | - | - |
Nervous System Disorder | Â | Â | Â | Â | Â | Â | Â |
  Headache | 1 (9%) | - | - | - | 3 (75%) | 3 (75%) | 1 (100%) |
  Dizziness |  | - | - |  | 1 (25%) | 1 (25%) | - |
  Hypoaesthesia | - | - | 1 (25%) | - | - | - | - |
  Paraesthesia | - | - | - | - | 1 (25%) | - | - |
  Presyncope |  | 1 (25%) | - | - |  | - | - |