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 (%).