{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"64"}]}],"title":"AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"45"}]}],"title":"Drug-related AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"41"}]}],"title":"Grade ≥3 AE"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}],"title":"Grade ≥3 Drug-related AE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"}],"units":"Participants"}],"description":"AE was defined as any untoward medical occurrence in a participant administered the study drug. AE included clinically significant changes in laboratory values, vital signs, and electrocardiograms. Drug-related AE was defined as AE that there was at least a reasonable possibility to have the causal relationship to the study drug. The severity of AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (Version 4.0) where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant but not immediately life-threatening), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).","groups":[{"description":"SP-02L (darinaparsin for injection): Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days","id":"OG000","title":"SP-02L (Darinaparsin for Injection)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.","title":"Number of Participants With Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"Participants"}