Table 2 Study drug related adverse events occurring in ≥ 5% of Subjects in the Phase 1b expansion study
From: Single low-dose rHuIL-12 safely triggers multilineage hematopoietic and immune-mediated effects
System organ class (preferred term) | Placebo | rHuIL-12 12 μg |
|---|---|---|
(N = 12) | (N = 48) | |
Blood and Lymphatic System Disorders | Â | Â |
  Lymphadenitis | 0 | 6 (13%) |
  Thrombocytopenia | 0 | 3 (6%) |
Eye Disorders | Â | Â |
  Photophobia | 1 (8%) | 0 |
Gastrointestinal Disorders | Â | Â |
  Nausea | 3 (25%) | 7 (15%) |
  Vomiting | 1 (8%) | 2 (4%) |
General Disorders and Administration Site Conditions | Â | Â |
  Chills | 1 (8%) | 11 (23%) |
  Fatigue | 1 (8%) | 7 (15%) |
  Feeling Hot | 3 (25%) | 5 (10%) |
  Injection Site Erythema | 0 | 5 (10%) |
  Injection Site Pain | 1 (8%) | 5 (10%) |
  Injection Site Reaction | 0 | 4 (8%) |
  Pain | 0 | 3 (6%) |
Investigations | Â | Â |
  Alanine Aminotransferase Increased | 0 | 3 (6%) |
Musculoskeletal and Connective Tissue Disorders | Â | Â |
  Myalgia | 1 (8%) | 11 (23%) |
  Back Pain | 0 | 10 (21%) |
  Arthralgia | 0 | 3 (6%) |
  Musculoskeletal Stiffness | 1 (8%) | 2 (4%) |
  Neck Pain | 1 (8%) | 1 (2%) |
Nervous System Disorders | Â | Â |
  Headache | 4 (33%) | 26 (54%) |
  Dizziness | 0 | 5 (10%) |