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Table 2 Differences in the Reporting Format of AEs (including irSAEs) between Published RCTs and Trial Results posted on ClinicalTrials.gov

From: The quality of reporting general safety parameters and immune-related adverse events in clinical trials of FDA-approved immune checkpoint inhibitors

Formatting component Published trials ClinicalTrials.gov
Causality
Establishing drug-causality for AEs
Primarily report treatment-related AEs (trAEs) All-cause AEs are reported regardless of drug causality
Structural hierarchy
The level at which different types of AE are reported
System Organ Class (SOC) and / or Preferred Terms (PTs) according to MedDRA are used
e.g., SOC: higher level group term (e.g., skin, GI)
PT: lower level group term (e.g., rash, colitis)
Report AE occurrence using PTs, but typically not by SOCs
Severity or grade
The intensity of an AE (mild, moderate, severe, etc.)
Often report AE grades; choice of presentation grading categories varies.
e.g., some publications report grade 3–4 combined, others report grades 3, 4 and 5 together.
Grading is most often not reported in trial registry results
Incidence of various types of AE
Reporting the number of patients or events
Generally report the number of AEs
e.g., number of events which included rashes (including all grades and multiple episodes in patients, unless explicitly indicated that the highest grade per patient is reported)
Usually report the number of patients who experienced each specific type of AE
e.g., number of patients in treatment arm 1 who experienced serious autoimmune colitis
Frequency threshold
The incidence of AEs occurring beyond a certain threshold
Authors often choose a higher frequency threshold to report AEs in the main text, however, they may choose to report a more comprehensive list using a lower cutoff in the supplementary tables
e.g., 10% in the main table and 1% in the supplement
ClinicalTrials.gov requires investigators to report all SAEs, and events ≥5% for non-SAEs
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