Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 11:32 PM
Ignite Modification Date: 2025-12-25 @ 9:20 PM
NCT ID: NCT02445456
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data was collected over the time between tracer injection until discharge from hospital after surgery. The range was 9-77 days due to differences in patient pathways.
Study: NCT02445456
Study Brief: Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ex-vivo Patients with relatively advanced rectal cancer who are scheduled to undergo radical surgery to excise rectal tumour and mesorectum. They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery. They will then undergo surgery to excise rectal cancer. The excised specimen will be examined using the Sentimag probe and by standard histology to assess for lymph nodes ex-vivo. Sienna+ injection: Endoscopic injection of magnetic tracer MRI scan: MRI scan of pelvis to detect spread of magnetic tracer Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM) Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+) 0 None 4 13 0 13 View
In-vivo Patients with early rectal cancer scheduled to undergo local excision of a rectal tumour by transanal endoscopic microsurgery (TEM). They will receive endoscopic Sienna+ injection (magnetic tracer) 5 days before planned surgery, and have an MRI scan to assess tracer spread. They will then undergo TEM surgery to excise the rectal cancer. During surgery the Sentimag probe will be used to locate the sentinel lymph node so it can be surgically removed. The excised specimen will be examined by standard histology. Sienna+ injection: Endoscopic injection of magnetic tracer MRI scan: MRI scan of pelvis to detect spread of magnetic tracer Surgery to excise rectal cancer: Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM) Sentimag probe: Probe to detect the previously injected magnetic tracer (Sienna+) 0 None 0 2 0 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Post-operative ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anastomotic leak NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):