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: 2025-12-25 @ 2:53 AM
Ignite Modification Date: 2025-12-26 @ 1:34 AM
NCT ID: NCT02289833
Description: None
Frequency Threshold: 5
Time Frame: From baseline to study completion (approximately 43 months)
Study: NCT02289833
Study Brief: A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor (HER)2 Immunohistochemistry (IHC)-Positive, Locally Advanced or Metastatic 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
Cohort IHC3+ Participants with HER2 IHC3-positive (IHC 3+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine. 16 None 5 20 19 20 View
Cohort IHC2+ Participants with HER2 IHC2-positive (IHC 2+) locally advanced or metastatic NSCLC, who had received at least one prior platinum-based chemotherapy regimen, will receive trastuzumab emtansine. 23 None 5 29 24 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra, Version 21.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra, Version 21.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra, Version 21.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra, Version 21.1 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra, Version 21.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra, Version 21.1 View
Craniocerebral injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra, Version 21.1 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra, Version 21.1 View
Tumour pain SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDra, Version 21.1 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra, Version 21.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra, Version 21.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra, Version 21.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra, Version 21.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDra, Version 21.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDra, Version 21.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDra, Version 21.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDra, Version 21.1 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDra, Version 21.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDra, Version 21.1 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDra, Version 21.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra, Version 21.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra, Version 21.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra, Version 21.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra, Version 21.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDra, Version 21.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDra, Version 21.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDra, Version 21.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra, Version 21.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDra, Version 21.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra, Version 21.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra, Version 21.1 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra, Version 21.1 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra, Version 21.1 View
Pulmonary pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra, Version 21.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra, Version 21.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra, Version 21.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra, Version 21.1 View
Hypomagnesaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra, Version 21.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra, Version 21.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra, Version 21.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra, Version 21.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra, Version 21.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra, Version 21.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra, Version 21.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra, Version 21.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra, Version 21.1 View
Mouth ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra, Version 21.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra, Version 21.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra, Version 21.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra, Version 21.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra, Version 21.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra, Version 21.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra, Version 21.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra, Version 21.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDra, Version 21.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDra, Version 21.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDra, Version 21.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDra, Version 21.1 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDra, Version 21.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDra, Version 21.1 View
Lymphocyte count decreased SYSTEMATIC_ASSESSMENT Investigations MedDra, Version 21.1 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDra, Version 21.1 View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra, Version 21.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra, Version 21.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra, Version 21.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra, Version 21.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra, Version 21.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra, Version 21.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra, Version 21.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra, Version 21.1 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra, Version 21.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra, Version 21.1 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra, Version 21.1 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra, Version 21.1 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra, Version 21.1 View
Skin Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra, Version 21.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra, Version 21.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra, Version 21.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra, Version 21.1 View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra, Version 21.1 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra, Version 21.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra, Version 21.1 View
Depressive symptom SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra, Version 21.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra, Version 21.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDra, Version 21.1 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDra, Version 21.1 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDra, Version 21.1 View
Poor venous access SYSTEMATIC_ASSESSMENT Vascular disorders MedDra, Version 21.1 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra, Version 21.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDra, Version 21.1 View
Odynophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra, Version 21.1 View
Mucosal Dryness SYSTEMATIC_ASSESSMENT General disorders MedDra, Version 21.1 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra, Version 21.1 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra, Version 21.1 View
Iron Deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra, Version 21.1 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra, Version 21.1 View
Pain in Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra, Version 21.1 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra, Version 21.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra, Version 21.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra, Version 21.1 View
Onychoclasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra, Version 21.1 View