Table 2.

Adverse events by dose group and intensity

	Dose	Mild	Moderate	Severe	Total
No. of subjects with AEs		28 (100%)	9 (100%)	6 (100%)	33 (100%)
Cardiac disorders
Angina pectoris	300 mg	1 (3.6%)	0 (0)	1 (16.7%)	2 (6.1%)
Atrial fibrillation	Placebo	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Eye disorders
Arcus lipoids	Placebo	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Vision blurred	300 mg	0 (0)	0 (0)	1 (16.7%)	1 (3.0%)
Gastrointestinal disorders
Abdominal distension	300 mg	2 (7.1%)	0 (0)	0 (0)	2 (6.1%)
Abdominal pain upper	100 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
	300 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
	500 mg	0 (0)	1 (11.1%)	0 (0)	1 (3.0%)
Diarrhea	100 mg	2 (7.1%)	0 (0)	0 (0)	2 (6.1%)
Dry mouth	300 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Dyspepsia	Placebo	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
	100 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Flatulence	300 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Gastric disorder	500 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Gastro‐esophageal reflux disease	500 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Hematochezia	Placebo	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Nausea	300 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
	500 mg	0 (0)	1 (11.1%)	0 (0)	1 (3.0%)
Toothache	100 mg	0 (0)	1 (11.1%)	0 (0)	1 (3.0%)
General disorders and administration site conditions
Chest pain	Placebo	0 (0)	2 (22.2%)	0 (0)	2 (6.1%)
	300 mg	0 (0)	0 (0)	1 (16.7%)	1 (3.0%)
Fatigue	500 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Edema	Placebo	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
	300 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Pain	Placebo	0 (0)	1 (11.1%)	0 (0)	1 (3.0%)
	500 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Immune system disorders
Hypersensitivity	500 mg	0 (0)	1 (11.1%)	0 (0)	1 (3.0%)
Infections and infestations
Ear infection	Placebo	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Influenza	100 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Nasopharyngitis	100 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
	300 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
	500 mg	5 (17.9%)	0 (0)	0 (0)	5 (15.2%)
Urinary tract infection	Placebo	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
	100 mg	2 (7.1%)	0 (0)	0 (0)	2 (6.1%)
	300 mg	2 (7.1%)	0 (0)	0 (0)	2 (6.1%)
	500 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Injury, poisoning, and procedural complications
Animal bite	500 mg	0 (0)	1 (11.1%)	0 (0)	1 (3.0%)
Contusion	500 mg	0 (0)	0 (0)	1 (16.7%)	1 (3.0%)
Limb injury	500 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Investigations
Cardiac murmur	100 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Musculoskeletal and connective tissue disorders
Arthralgia	Placebo	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Back pain	300 mg	0 (0)	1 (11.1%)	0 (0)	1 (3.0%)
	500 mg	0 (0)	0 (0)	1 (16.7%)	1 (3.0%)
Chest wall pain	Placebo	0 (0)	1 (11.1%)	0 (0)	1 (3.0%)
Muscle spasms	Placebo	0 (0)	1 (11.1%)	0 (0)	1 (3.0%)
	300 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Musculoskeletal pain	500 mg	0 (0)	0 (0)	1 (16.7%)	1 (3.0%)
Myalgia	Placebo	0 (0)	1 (11.1%)	0 (0)	1 (3.0%)
	500 mg	1 (3.6%)	1 (11.1%)	0 (0)	2 (6.1%)
Pain in extremity	300 mg	1 (3.6%)	0 (0)	2 (33.3%)	3 (9.1%)
	500 mg	2 (7.1%)	0 (0)	0 (0)	2 (6.1%)
Shoulder pain	Placebo	0 (0)	1 (11.1%)	0 (0)	1 (3.0%)
Nervous system disorders
Headache	100 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Syncope vasovagal	500 mg	0 (0)	0 (0)	1 (16.7%)	1 (3.0%)
Respiratory, thoracic, and mediastinal disorders
Rhinorrhea	100 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Throat irritation	300 mg	1 (3.6%)	0 (0)	0 (0)	1 (3.0%)
Skin and subcutaneous tissue disorders
Pruritus	Placebo	0 (0)	1 (11.1%)	0 (0)	1 (3.0%)

AEs, adverse events.