Table 2. Summary of all adverse events reported during the trial.
Treatment (n, %) | Placebo (n, %) | P | |
---|---|---|---|
Treatment emergent adverse events | |||
Total participants with ≥1 | 16 (21.1) | 16 (20.5) | 0.93 |
Related, likely related, or possibly related | |||
Administration site conditions | |||
Site pain | 4 (5.3) | 2 (2.6) | 0.5 |
Site pruritus | 1 (1.3) | 0 | |
Site urticaria | 1 (1.3) | 0 | |
Contact dermatitis | 0 | 2 (2.6) | |
Unrelated | |||
Hypothyroidism | 0 | 1 (1.3) | 1.0 |
Lacrimation increase | 1 (1.3) | 0 | 1.0 |
Gastrointestinal | |||
Abdominal pain | 0 | 1 (1.3) | 1.0 |
Diarrhea | 0 | 1 (1.3) | 1.0 |
Vomiting | 1 (1.3) | 0 | 1.0 |
Seasonal allergies | 0 | 1 (1.3) | 1.0 |
Infections | |||
Appendicitis (*severe AE) | 1 (1.3) | 0 | 1.0 |
Blister infection | 0 | 1 (1.3) | 1.0 |
Folliculitis | 1 (1.3) | 0 | 1.0 |
Gastroenteritis, viral | 0 | 1 (1.3) | 1.0 |
Molluscum contagiosum | 1 (1.3) | 0 | 1.0 |
Nasopharyngitis | 1 (1.3) | 0 | 1.0 |
Sinusitis | 1 (1.3) | 0 | 1.0 |
Tinea versicolor | 0 | 1 (1.3) | 1.0 |
Upper respiratory tract infection | 1 (1.3) | 1 (1.3) | 1.0 |
Injury | 4 (5.3) | 4 (5.1) | 1.0 |
Musculoskeletal | |||
Arthralgia | 1 (1.3) | 1 (1.3) | 1.0 |
Back pain | 2 (2.6) | 0 | 0.3 |
Bone lesion | 1 (1.3) | 0 | 1.0 |
Groin pain | 0 | 1 (1.3) | 1.0 |
Osteochondrosis | 0 | 1 (1.3) | 1.0 |
Headache | 0 | 1 (1.3) | 1.0 |
Sciatica | 0 | 1 (1.3) | 1.0 |
Anxiety/depression | 0 | 1 (1.3) | 1.0 |
Asthma | 0 | 1 (1.3) | 1.0 |
Rhinorrhea | 1 (1.3) | 0 | 1.0 |
Ingrown nail | 0 | 1 (1.3) | 1.0 |