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 @ 6:40 PM
Ignite Modification Date: 2025-12-25 @ 4:11 PM
NCT ID: NCT02237157
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected during the treatment period, an average of 2.5 months
Study: NCT02237157
Study Brief: A Dose Escalation Safety Study of Locally-Delivered Gemcitabine in Pancreatic 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
Gemcitabine, Local Delivery (Dose 2) Gemcitabine; 1 cycle, two doses per cycle; 500mg/m2 dose Gemcitabine, local delivery: Intra-arterial targeted drug delivery 0 None 4 15 7 15 View
Gemcitabine, Local Delivery (Dose 3) Gemcitabine; 1 cycle, two doses per cycle; 750mg/m2 dose Gemcitabine, local delivery: Intra-arterial targeted drug delivery 0 None 3 11 4 11 View
Gemcitabine, Local Delivery (Dose 1) Gemcitabine; 1 cycle, two doses per cycle; 250mg/m2 dose Gemcitabine, local delivery: Intra-arterial targeted drug delivery 0 None 5 20 7 20 View
Gemcitabine, Local Delivery (Dose 4) Gemcitabine; 1 cycle, two doses per cycle; 1000mg/m2 dose Gemcitabine, local delivery: Intra-arterial targeted drug delivery 0 None 2 8 0 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Duodenal Obstruction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intraoperative Arterial Injury - Lower Extremity NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intraoperative Arterial Injury / Dissection NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pain - Abdominal (NOS) NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Respiratory Failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arterial spasm NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Incontinence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intraoperative arterial injury - lower extremity NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Median arcuate ligament syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vasovagal episode NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Intraoperative arterial injury - pseudoaneurysm NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View