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 @ 11:58 PM
Ignite Modification Date: 2025-12-25 @ 9:56 PM
NCT ID: NCT02438358
Description: None
Frequency Threshold: 0
Time Frame: Patients were evaluated for adverse events from time of injection until standard psot-surgery follow-up visit. (Median 31 days after lumpectomy).
Study: NCT02438358
Study Brief: Feasibility Study of Intraoperative Imaging in Breast 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
Phase A: LUM015 1.0 mg/kg 5 participants were administered with a single dose of LUM015 at 1.0 mg/kg by intravenous injection between 2 and 6 hours prior to surgery. All participants will have intraoperative imaging using the LUM 2.6 Imaging Device. 0 None 0 5 0 5 View
Phase B: LUM015 1.0 mg/kg 45 participants were administered with a single dose of LUM015 at 1.0 mg/kg by intravenous injection between 2 and 6 hours prior to surgery. Participants will then undergo lumpectomy followed by LUM imagining of the lumpectomy cavity. Comprehensive shaves will be performed followed by LUM015 imagining of the resulting cavity and resection of LUM-imagining-positive cavity tissue. 0 None 0 45 5 45 View
Phase A: No Dose 5 participants were not administered with LUM015. All participants will have intraoperative imaging using the LUM 2.6 Imaging Device. 0 None 0 5 0 5 View
Phase A: LUM015 0.5 mg/kg 5 participants were administered with a single dose of LUM015 at 0.5 mg/kg by intravenous injection between 2 and 6 hours prior to surgery. All participants will have intraoperative imaging using the LUM 2.6 Imaging Device. 0 None 0 5 0 5 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Procedural Nausea SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.1 View
Extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Suture Related Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View
Post Procedural Hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 22.1 View