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 @ 2:32 AM
Ignite Modification Date: 2025-12-26 @ 1:08 AM
NCT ID: NCT00979134
Description: None
Frequency Threshold: 5
Time Frame: AEs were collected on a continual basis from Screening up until the end of the 28 day follow up period.
Study: NCT00979134
Study Brief: Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part B Dose expansion phase (80mg bd tablet) None None 1 6 6 6 View
Part C (FISH Ratio >= 2) Dose expansion in patients with FGFR gene-amplified tumours None None 10 33 33 33 View
Part A Dose escalation None None 11 43 43 43 View
Part C (FISH Ratio < 2) Dose expansionj in patients with FGFR gene-amplified tumours None None 3 12 12 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 14.1. View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 14.1. View
ALT increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 14.1. View
GGT increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 14.1. View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 14.1. View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 14.1. View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 14.1. View
Pelvi-ureteric obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 14.1. View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 14.1. View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 14.1. View
Tumour associated fever SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 14.1. View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 14.1. View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 14.1. View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 14.1. View
Chorioretinopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 14.1. View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 14.1. View
Atrial flutter SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 14.1. View
Bile duct obstruction SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 14.1. View
Decreased appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1. View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 14.1. View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.1. View
Euthanasia SYSTEMATIC_ASSESSMENT Social circumstances MedDRA Version 14.1. View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 14.1. View
Hypotension SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.1. View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 14.1. View
Pericardial effusion SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 14.1. View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 14.1. View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 14.1. View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 14.1. View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 14.1. View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1. View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 14.1. View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1. View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 14.1. View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1. View
Stomatis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1. View
Hyperphosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 14.1. View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 14.1. View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1. View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 14.1. View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1. View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 14.1. View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1. View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 14.1. View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 14.1. View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 14.1. View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 14.1. View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.1. View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 14.1. View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1. View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.1. View
Muscle spasms SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.1. View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 14.1. View
Breath sounds abnormal SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 14.1. View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 14.1. View
Ageusia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 14.1. View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 14.1. View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.1. View
Oedema peripheral SYSTEMATIC_ASSESSMENT Eye disorders MedDRA Version 14.1. View
ALT increased SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 14.1. View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 14.1. View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.1. View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 14.1. View
Dyspepsia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 14.1. View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 14.1. View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 14.1. View