Type and frequency of adverse events
. | Treatment group* . | . | . | . | |||
|---|---|---|---|---|---|---|---|
| Adverse event . | Placebo . | 0.025 mg/kg . | 0.05 mg/kg . | 0.1 mg/kg . | |||
| No. subjects | 8 | 5 | 5 | 10 | |||
| Cardiac disorder: palpitations | 0 | 1 (20.0) | 0 | 0 | |||
| Gastrointestinal disorders | |||||||
| Abdominal distention | 0 | 1 (20.0) | 0 | 0 | |||
| Abdominal pain | 0 | 1 (20.0) | 0 | 1 (10.0) | |||
| Constipation | 0 | 1 (20.0) | 0 | 0 | |||
| Diarrhea | 0 | 1 (20.0) | 0 | 0 | |||
| Nausea | 0 | 0 | 0 | 2 (20.0) | |||
| General disorders | |||||||
| Fatigue | 0 | 1 (20.0) | 0 | 0 | |||
| Thirst | 0 | 0 | 0 | 1 (10.0) | |||
| Immune system disorder: drug hypersensitivity | 0 | 1 (20.0) | 0 | 0 | |||
| Infection: nasopharyngitis | 3 (37.5) | 0 | 0 | 2 (20.0) | |||
| Injury | |||||||
| Head injury | 0 | 0 | 0 | 1 (10.0) | |||
| Joint sprain | 0 | 0 | 0 | 1 (10.0) | |||
| Limb injury | 1 (12.5) | 0 | 0 | 0 | |||
| Musculoskeletal disorder: back pain | 0 | 0 | 0 | 1 (10.0) | |||
| Nervous system disorders | |||||||
| Dizziness | 0 | 0 | 0 | 1 (10.0) | |||
| Headache | 1 (12.5) | 1 (20.0) | 0 | 3 (30.0) | |||
| Syncope vasovagal | 1 (12.5) | 0 | 0 | 0 | |||
| Reproductive system disorder: | |||||||
| testicular disorder | 0 | 0 | 0 | 1 (10.0) | |||
. | Treatment group* . | . | . | . | |||
|---|---|---|---|---|---|---|---|
| Adverse event . | Placebo . | 0.025 mg/kg . | 0.05 mg/kg . | 0.1 mg/kg . | |||
| No. subjects | 8 | 5 | 5 | 10 | |||
| Cardiac disorder: palpitations | 0 | 1 (20.0) | 0 | 0 | |||
| Gastrointestinal disorders | |||||||
| Abdominal distention | 0 | 1 (20.0) | 0 | 0 | |||
| Abdominal pain | 0 | 1 (20.0) | 0 | 1 (10.0) | |||
| Constipation | 0 | 1 (20.0) | 0 | 0 | |||
| Diarrhea | 0 | 1 (20.0) | 0 | 0 | |||
| Nausea | 0 | 0 | 0 | 2 (20.0) | |||
| General disorders | |||||||
| Fatigue | 0 | 1 (20.0) | 0 | 0 | |||
| Thirst | 0 | 0 | 0 | 1 (10.0) | |||
| Immune system disorder: drug hypersensitivity | 0 | 1 (20.0) | 0 | 0 | |||
| Infection: nasopharyngitis | 3 (37.5) | 0 | 0 | 2 (20.0) | |||
| Injury | |||||||
| Head injury | 0 | 0 | 0 | 1 (10.0) | |||
| Joint sprain | 0 | 0 | 0 | 1 (10.0) | |||
| Limb injury | 1 (12.5) | 0 | 0 | 0 | |||
| Musculoskeletal disorder: back pain | 0 | 0 | 0 | 1 (10.0) | |||
| Nervous system disorders | |||||||
| Dizziness | 0 | 0 | 0 | 1 (10.0) | |||
| Headache | 1 (12.5) | 1 (20.0) | 0 | 3 (30.0) | |||
| Syncope vasovagal | 1 (12.5) | 0 | 0 | 0 | |||
| Reproductive system disorder: | |||||||
| testicular disorder | 0 | 0 | 0 | 1 (10.0) | |||
Except for the “No. patients” row, all data are presented as number of subjects experiencing adverse event (%).