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 @ 11:14 PM
Ignite Modification Date: 2025-12-25 @ 8:49 PM
NCT ID: NCT01652469
Description: One patient from the Docetaxel arm never started treatment.
Frequency Threshold: 3
Time Frame: None
Study: NCT01652469
Study Brief: Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
B: Docetaxel Docetaxel in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Docetaxel: Docetaxel 75 mg/m2 as an IV infusion every 21 days. 3 None 19 41 39 41 View
A: Erlotinib Erlotinib in standard dose. Until progression (clinical or radiological) or unacceptable toxicity. Erlotinib: Erlotinib 150 mg/day p.o. continuously with 21 days cycle. 7 None 7 38 36 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia None Blood and lymphatic system disorders None View
Lung infection None Infections and infestations None View
Bronchial infection None Infections and infestations None View
Abdominal pain None Gastrointestinal disorders None View
Acidosis None Metabolism and nutrition disorders None View
Atrial flutter None Cardiac disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Bronchial obstruction None Respiratory, thoracic and mediastinal disorders None View
Bronchopulmonary hemorrhage None Respiratory, thoracic and mediastinal disorders None View
Cardiac arrest None Cardiac disorders None View
Death NOS None General disorders None View
Dehydration None Metabolism and nutrition disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Fatigue None General disorders None View
Fever None General disorders None View
Hip fracture None Injury, poisoning and procedural complications None View
Infections and infestations None Infections and infestations None View
Jejunal perforation None Gastrointestinal disorders None View
Joint effusion None Musculoskeletal and connective tissue disorders None View
Neutrophil count decreased None Investigations None View
Renal and urinary disorders None Renal and urinary disorders None View
Respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Sepsis None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Vomiting None Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue None General disorders None View
Dyspnea None Respiratory, thoracic and mediastinal disorders None View
Rash maculo-papular None Skin and subcutaneous tissue disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Diarrhea None Gastrointestinal disorders None View
Anorexia None Metabolism and nutrition disorders None View
Neutrophil count decreased None Investigations None View
Mucositis oral None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Alopecia None Skin and subcutaneous tissue disorders None View
Pain None General disorders None View
Dry skin None Skin and subcutaneous tissue disorders None View
Lung infection None Infections and infestations None View
Dizziness None Nervous system disorders None View
Fever None General disorders None View
Vomiting None Gastrointestinal disorders None View
Edema limbs None General disorders None View
Flu-like symptoms None General disorders None View
Hypertension None Vascular disorders None View
Abdominal pain None Gastrointestinal disorders None View
Anemia None Blood and lymphatic system disorders None View
Aspartate aminotransferase increase None Investigations None View
Conjuctivitis None Eye disorders None View
Constipation None Gastrointestinal disorders None View
Death NOS None General disorders None View
Peripheral sensory neuropathy None Nervous system disorders None View
Bone pain None Musculoskeletal and connective tissue disorders None View
Creatinine increase None Investigations None View
Dysphagia None Gastrointestinal disorders None View
Gastrointestinal disorders None Gastrointestinal disorders None View
Nail discoloration None Skin and subcutaneous tissue disorders None View
Oral dysesthesia None Gastrointestinal disorders None View
Tumor pain None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View