NCT04267575 · ADVERSE EVENTS

Adverse events

Canady Helios Cold Plasma Scalpel Treatment at the Surgical Margin and Macroscopic Tumor Sites · Source last updated 2021-08-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Data has been collected for 16 months as of 5/21/21
Other-event reporting threshold: 0%

There have been 0 adverse events.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Primary Arm Patients received previous chemotherapy, radiation, immuno-therapy and/or surgery prior to metastatic recurrent disease. In this study, the patients gross solid tumor was removed, and cold plasma was sprayed in the area of the resected tumor margins. Canady Helios Cold Plasma Scalpel: Device used to distribute cold plasma energy at the resected tumor margins. Post-operatively, patients will be started back on Adjuvant chemotherapy, radiation, or immuno-therapy as per medical oncology and multi-disciplinary team.	0 / 20	0 / 20	2 / 20

Group identifiers: EG000: Primary Arm

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

description

There have been 0 adverse events.

event Groups

deaths Num Affected
2
deaths Num At Risk
20
description
Patients received previous chemotherapy, radiation, immuno-therapy and/or surgery prior to metastatic recurrent disease. In this study, the patients gross solid tumor was removed, and cold plasma was sprayed in the area of the resected tumor margins. Canady Helios Cold Plasma Scalpel: Device used to distribute cold plasma energy at the resected tumor margins. Post-operatively, patients will be started back on Adjuvant chemotherapy, radiation, or immuno-therapy as per medical oncology and multi-disciplinary team.
id
EG000
other Num Affected
0
other Num At Risk
20
serious Num Affected
0
serious Num At Risk
20
title
Primary Arm

frequency Threshold

time Frame

Data has been collected for 16 months as of 5/21/21

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice