Single Ascending Dose Safety and Pharmacokinetics of CDRI-97/78: First-in-Human Study of a Novel Antimalarial Drug

Table 3

Description of all adverse events observed in the study.

Name of AE	Treatment group	Treatment given	Time (hrs) of onset after drug administration	Duration of AE (min)	Spontaneous reversal (yes or no)	Reversal complete (yes or no)	Severity grade	Causality assessment
Sedation	600 mg	None	2	60	Yes	Yes	1-2	Possible
Sedation	500 mg	None	2	120	Yes	Yes	1-2	Possible
Sedation	Placebo	None	2	120	Yes	Yes	1-2	Not drug related
Drowsiness	400 mg	None	2	60	Yes	Yes	1	Possible
Drowsiness	Placebo	None	1.5	140	Yes	Yes	1	Not drug related
Nausea	500 mg	None	0.25	20	Yes	Yes	1	Possible
Nausea	Placebo	None	Immediate	10	Yes	Yes	3	Not drug related
Heaviness of head	80 mg	None	0.25	15	Yes	Yes	1	Possible
Heaviness of head	Placebo	None	1	10	Yes	Yes	1	Not drug related
Visual disturbances	320 mg	None	36	2-3	Yes	Yes	1	Remote
Bradycardia	400 mg	None	1	60	Yes	Yes	1	Possible
Retching	Placebo	None	Immediate	10	Yes	Yes	3	Not drug related
Itching	400 mg	None	24	8	Yes	Yes	1	Possible
Dizziness	Placebo	None	1	10	Yes	Yes	3	Not drug related

Severity grading done according to Common Terminology Criteria for Adverse Events v4.0, US Department of Health and Human Services. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
Causality assessment: None; remote (<5% chance of being drug related); possible (>5% but ≤50% chance of being drug related; probable (>50% chance of being drug related) and definite.
Grade 3 severity—volunteer was on placebo.