NCT03735680
Version 10 to 11 · OncoNano Medicine, Inc.
Patch inspector
Manual review pending.
adverse_event_group_change None recorded.
99b3725269fe96e03c188d741f521a26136ed332275de48f6dc98bd31e50c356/resultsSection/adverseEventsModule/timeFrame Safety results are available for all 30 patients enrolled in Part 1 (n=9 patients), Part 2 (n=10 patients) and Part 3 (n=11 patients). All patients enrolled in this study received a single dose of ONM-100. The total collection period for each subject was approximately one month.
The total collection period for each subject was approximately one month.
/resultsSection/adverseEventsModule/description No adverse events leading to death were reported.
/resultsSection/adverseEventsModule/eventGroups/0/title adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority. Patients Receiving ONM-100
Patients Receiving Any Dose of ONM-100
/resultsSection/adverseEventsModule/eventGroups/0/description adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority. Overall treatment-emergent adverse events reported in patients receiving ONM-100.
Safety analyses were conducted in the Safety Population (all patients who received any dose of ONM-100). Safety results are available for all 30 patients enrolled in Part 1 (n=9 patients), Part 2 (n=10 patients), and Part 3 (n=11 patients).
/resultsSection/adverseEventsModule/eventGroups/0/deathsNumAtRisk adverse_event_group_change Changes to adverse event group-level denominators or affected counts are high review priority. 0
30
/resultsSection/adverseEventsModule/reviewUnit {
"resetReasons": [
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]
} /resultsSection/adverseEventsModule/allCauseMortalityReviewUnit {
"resetReasons": [
"The Adverse Event Reporting Description does not appear to explain why the Number of Participants at Risk is zero."
]
} /protocolSection/statusModule/statusVerifiedDate 2023-04
2023-05
/protocolSection/statusModule/lastUpdateSubmitDate 2023-04-19
2023-05-23
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2023-05-12
2023-06-18
/resultsSection/baselineCharacteristicsModule/groups/5/description Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at XXX hours post dose.
Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 24 ±8 hours post dose.
/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date 2023-05-11
2023-06-15
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/unitOfMeasure units on a scale
ratio
/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/measureCategoriesReviewUnit {
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} /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms/0/counts/1/value 4
3
/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/measureCategoriesReviewUnit {
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} /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/denoms/0/counts/1/value 4
3
/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit {
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