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: 2025-12-26 @ 2:43 PM
Ignite Modification Date: 2025-12-26 @ 2:43 PM
NCT ID: NCT02013206
Description: None
Frequency Threshold: 4
Time Frame: Up to 2 Years
Study: NCT02013206
Study Brief: A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Current/Former Smokers Current Smokers (participants who smoked \> 100 cigarettes in entire lifetime and either quit smoking \< 1 year ago or were currently smoking) or Former Smokers (participants who smoked \> 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib \[Tarceva\] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity. None None 14 26 26 26 View
Never Smokers Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib \[Tarceva\] 150 mg orally daily until disease progression or unacceptable toxicity. None None 7 23 23 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Performance status decreased SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pseudomonas infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Tumour necrosis SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Anuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Ovarian disorder SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Biopsy muscle SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.0 View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 11.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Dry Eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Growth of eyelashes SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Xerosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Hepatobiliary disorders SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.0 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Injury, poisoning and procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Reproductive system and breast disorders SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Skin fissures SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Trichomegaly SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 11.0 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Mucosal dryness SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Skin toxicity SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Surgical and medical procedures SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.0 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View