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 @ 2:30 AM
Ignite Modification Date: 2025-12-26 @ 1:05 AM
NCT ID: NCT00862134
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00862134
Study Brief: Randomized, Multi-center, Open-label, Study of PR104 Versus PR104/Docetaxel in Non-Small Cell Lung Cancer (NSCLC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Docetaxel 75 mg/m\^2 docetaxel, IV, every 21 days None None 8 17 17 17 View
PR104 + Docetaxel Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m\^2 docetaxel, IV, every 21 days plus 770 mg/m\^2 PR104, IV, every 21 days and prophylactic G-CSF. None None 5 23 23 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sepsis None Infections and infestations None View
Chest Pain (atypical) None General disorders None View
Acute Myocardial Infarction None Cardiac disorders None View
Ileus, GI None Gastrointestinal disorders None View
Acute RLL Pneumonia None Infections and infestations None View
Neutropenic Sepsis None Infections and infestations None View
Gastrointestinal Bleed None Gastrointestinal disorders None View
Dehydration None Metabolism and nutrition disorders None View
Gastroenteritis None Gastrointestinal disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Acute Respiratory Distress None Respiratory, thoracic and mediastinal disorders None View
Spinal Cord Compression None Injury, poisoning and procedural complications None View
Neutropenic Fever None Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia None Blood and lymphatic system disorders None View
Neutropenia None Blood and lymphatic system disorders None View
Leukopenia None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Hyperglycaemia None Metabolism and nutrition disorders None View
Hypoalbuminaemia None Metabolism and nutrition disorders None View
Dehydration None Metabolism and nutrition disorders None View
Hyponatraemia None Metabolism and nutrition disorders None View
Fatigue None General disorders None View
Non-cardiac chest pain None General disorders None View
Asthenia None General disorders None View
Irritability None General disorders None View
Oedema None General disorders None View
Oedema peripheral None General disorders None View
Diarrhoea None General disorders None View
Anorexia None Metabolism and nutrition disorders None View
Hypocalcaemia None Metabolism and nutrition disorders None View
Hypokalaemia None Metabolism and nutrition disorders None View
Constipation None Gastrointestinal disorders None View
Diarrhoea None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Stomatitis None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Abdominal pain None Gastrointestinal disorders None View
Gastric ileus None Gastrointestinal disorders None View
Glossodynia None Gastrointestinal disorders None View
Pneumonia None Infections and infestations None View
Candidiasis None Infections and infestations None View
Bronchitis None Infections and infestations None View
Fungal infection None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Staphylococcal infection None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Viral infection None Infections and infestations None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Respiratory distress None Respiratory, thoracic and mediastinal disorders None View
Chronic obstructive pulmonary disease None Respiratory, thoracic and mediastinal disorders None View
Epistaxis None Respiratory, thoracic and mediastinal disorders None View
Pleural effusion None Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism None Respiratory, thoracic and mediastinal disorders None View
Pulmonary hypertension None Respiratory, thoracic and mediastinal disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Headache None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Decubitus ulcer None Skin and subcutaneous tissue disorders None View
Skin exfoliation None Skin and subcutaneous tissue disorders None View
Insomnia None Psychiatric disorders None View
Delirium None Psychiatric disorders None View
Alanine aminotransferase increased None Investigations None View
Aspartate aminotransferase increased None Investigations None View
Electrocardiogram abnormal None Investigations None View
Hepatitis C virus None Investigations None View
Clavicle fracture None Injury, poisoning and procedural complications None View
Acute myocardial infarction None Cardiac disorders None View
Angina pectoris None Cardiac disorders None View
Hyperbilirubinaemia None Hepatobiliary disorders None View
Benign prostatic hyperplasia None Reproductive system and breast disorders None View