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 @ 3:59 PM
Ignite Modification Date: 2025-12-25 @ 2:02 PM
NCT ID: NCT00370292
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00370292
Study Brief: Dosage Schedule Study of Pemetrexed Monochemotherapy for 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
Pemetrexed 500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue. None None 5 19 19 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Arrhythmia supraventricular SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Salivary gland calculus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Transaminases SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.1 View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 10.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Balanitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Petechiae SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.1 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.1 View
Omphalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Skin exfoliation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View