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The total collection period for each subject was approximately one month."},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/description","value":"Overall treatment-emergent adverse events reported in patients receiving ONM-100."},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk","value":0},{"op":"replace","path":"/resultsSection/adverseEventsModule/eventGroups/0/otherNumAffected","value":26},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/0/organSystem","value":"Infections and infestations"},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/0/assessmentType","value":"SYSTEMATIC_ASSESSMENT"},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/1/term","value":"Abscess neck"},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/1/organSystem","value":"Infections and infestations"},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/2/term","value":"Tonsillar hemorrhage"},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/2/organSystem","value":"Respiratory, thoracic and mediastinal disorders"},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/4/term","value":"Superficial vein thrombosis"},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/4/organSystem","value":"Vascular disorders"},{"op":"replace","path":"/resultsSection/adverseEventsModule/seriousEvents/5/term","value":"Infusion related reaction"},{"op":"add","path":"/resultsSection/adverseEventsModule/description","value":"No adverse events leading to death were reported."},{"op":"add","path":"/resultsSection/adverseEventsModule/reviewUnit","value":{"resetReasons":["A free-text field appears to include results data or conclusions drawn from the data. All results data must be reported in a tabular format."]}},{"op":"add","path":"/resultsSection/adverseEventsModule/allCauseMortalityReviewUnit","value":{"resetReasons":["The Adverse Event Reporting Description does not appear to explain why the Number of Participants at Risk is zero."]}},{"op":"replace","path":"/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date","value":"2023-05-11"},{"op":"add","path":"/reviewUnit","value":{"resetReasons":["Issues noted on a previous submission of this record do not appear to have been addressed."]}}],"provenance":{"from_snapshot_hash":"84e2c2cc603b91a9f29ecd6bafd847dbf3da0a7a5bf788ff1a134934d20dd923","materiality_event_hash":"13b8aada25050f4ab6ea923a55d46257e6fcc65d3f8f3f745b8cee012659310c","patch_hash":"07493602bef2c37bc1fd6d8f599b2b18834c10d5111091aa0d43d13bbba7858b","patch_raw_hash":"a818e78377b07c66df4bd767a347ef5f5f7f6fe7001215ce3b97715ce678cb58","patch_source":"ctgov_internal_history","patch_source_url":"https://clinicaltrials.gov/api/int/studies/NCT03735680/history/9?patchToVersion=10","to_snapshot_hash":"19d6665a1765db879a8dba6957017a9accda519135b4e0d068f0c926c6eb6ad6"},"review_question":"What source document explains the modified serious adverse event results record?","schema":"trialdiff.evidence_record","trial":{"clinicaltrials_gov_url":"https://clinicaltrials.gov/study/NCT03735680","nct_id":"NCT03735680"},"versions":{"from_version":9,"submitted_date":"2023-04-19","to_version":10}}