Table 1:

Elements of reporting toxicities and outcome assignments

Reporting element	Outcome assignments
What minimum incidence was utilized for reporting toxicities of any grade?	1 patient, 2-3 patients, 5% incidence, 10% incidence, 15-20% incidence, ≥25% incidence, not reported
What minimum incidence was utilized for reporting toxicities grade ≥ 3?	1 patient, 2-3 patients, 5% incidence, 10% incidence, 15-20% incidence, ≥25% incidence, not reported
Were treatment-related toxicities reported?	Y/N/Not reported
Were treatment-emergent toxicities reported?	Y/N/Not reported
Was a dose-escalation component included?	Y/N
Were adverse events combined across dose levels if dose-escalation was included?	Y/N
Were dose-limiting toxicities reported if the trial included a dose-escalation component?	Y/N
Were key dose-limiting toxicity criteria described?	Y/N
Were serious adverse events reported?	Y/N
Were key serious adverse event criteria described?	Y/N
Were adverse events leading to treatment change reported?	Y/N
Were standardized terminology (CTCAE or MedDRA) utilized?	Y/N
Were grouped adverse event terms utilized?	Y/N
Was overall incidence of adverse events at organ system level reported?	Y/N
Was the total number of patients with any adverse event any grade reported?	Y/N
Was the total number of patients with any adverse event grade ≥ 3 reported?	Y/N