Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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: 2025-12-25 @ 2:04 AM
Ignite Modification Date: 2025-12-26 @ 12:29 AM
NCT ID: NCT03490760
Description: None
Frequency Threshold: 0
Time Frame: 1 year, 3 months
Study: NCT03490760
Study Brief: Durvalumab and "Booster" Radiation in Metastatic Adenocarcinoma of the Pancreas
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Durvalumab Plus Radiation Therapy Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks plus 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. Durvalumab: Durvalumab 1500 mg (or 20 mg/m2 if \<30 kg) IV every 4 weeks Radiation Therapy: 24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5. 7 None 3 7 6 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute cystitis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Rectal bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GI bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Low Albumin on Blood NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Increased alkaline phosphatase NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Testicular pain NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Elevated troponin NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Generalized weakness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Protein calorie malnutrition NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Aspiration pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bilateral pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Shortness of breath NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View