Table 5.
Adverse events impacting at least 2 individuals and/or achieving grade 2 severity
| Adverse events | Treatment | ||
|---|---|---|---|
| Oxytocin (n = 12) | Placebo (n = 12) | All (n = 13) | |
| Adverse event of special interest | |||
| Epistaxis | 3 (23%) | 2 (15%) | 3 (23%) |
| Nasal congestion/irritation | 4 (31%) | 0 (0%) | 4 (31%) |
| Nausea/vomiting | 1 (8%) | 3 (23%) | 4 (31%) |
| Headache | 3 (23%) | 4 (31%) | 6 (46%) |
| Rash | 0 (0%) | 1 (8%) | 1 (8%) |
| Hyponatremia | 1 (8%) | 2 (15%) | 2 (15%) |
| Hypertension | 5 (38%) | 5 (38%) | 6 (46%) |
| Hypotension | 1 (8%) | 1 (8%) | 2 (15%) |
| Sinus tachycardia | 4 (31%) | 5 (38%) | 7 (54%) |
| QTc interval prolonged | 2 (15%) | 3 (23%) | 5 (38%) |
| Sinus bradycardia | 2 (15%) | 2 (15%) | 3 (23%) |
| Adverse events leading to treatment discontinuation | |||
| QTc interval prolonged | 1 (8%) | 1 (8%) | 2 (15%) |
| Other adverse events (affecting 2 or more participants and/or CTCAE Grade ≥ 2) | |||
| Fatigue | 2 (15%) | 0 (0%) | 2 (15%) |
| Irritability | 1 (8%) | 1 (8%) | 2 (15%) |
| Constipation | 2 (15%) | 0 (0%) | 2 (15%) |
| Diarrhea | 0 (0%) | 3 (23%) | 3 (23%) |
| Gastrointestinal – other (rectal irritation) | 1 (8%) | 1 (8%) | 1 (8%) |
| Gastrointestinal – other (worsening IBS) | 1 (8%) | 0 (0%) | 1 (8%) |
| Gastrointestinal – other (worsening heartburn) | 0 (0%) | 1 (8%) | 1 (8%) |
| Allergic Rhinitis | 2 (15%) | 0 (0%) | 2 (15%) |
| Sore Throat | 2 (15%) | 2 (15%) | 4 (27%) |
| Insomnia | 1 (8%) | 1 (8%) | 2 (15%) |
| Skin and Subcutaneous Tissue – other (Dermatitis) | 1 (8%) | 0 (0%) | 1 (8%) |
| Skin and Subcutaneous Tissue – other (Dry Lips) | 0 (0%) | 1 (8%) | 1 (8%) |
| Myalgia | 1 (8%) | 1 (8%) | 2 (15%) |
| Infections – other (Pharyngitis, Sinusitis) | 0 (0%) | 1 (8%) | 1 (8%) |
| Investigations – other (Low free T4) | 1 (8%) | 2 (15%) | 3 (23%) |
| Investigations – other (Elevated AST) | 1 (8%) | 0 (0%) | 1 (8%) |
| Investigations – other (Elevated bilirubin) | 0 (0%) | 1 (8%) | 1 (8%) |
Prevalence of adverse events of special interest, leading to treatment discontinuation, and reported by at least 2 individuals and/or reaching CTCAE Grade 2 severity are shown for all individuals who received at least one dose of oxytocin (n = 12), placebo (n = 12), or either (n = 13). All adverse events were Grades 0, 1, or 2 severity. Grade 0 referred to abnormalities outside the reference range, but not sufficiently abnormal to rate.