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 @ 12:27 AM
Ignite Modification Date: 2025-12-25 @ 10:32 PM
NCT ID: NCT00423267
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00423267
Study Brief: POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Posaconazole Period B None None None 1 12 8 12 View
Posaconazole Period A None None None 0 9 8 9 View
Fluconazole Period A None None None 0 7 5 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
HIP FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
SINUSITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
SWELLING SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 12.0 View
BRONCHITIS VIRAL SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
BRONCHOPNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
EAR INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
INCISION SITE INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
ORAL HERPES SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
PAROTITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
PHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
THROMBOPHLEBITIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
VARICOSE VEIN SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
BRADYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
PALPITATIONS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
DEAFNESS SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
VERTIGO SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
HYPOTHYROIDISM SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 12.0 View
DRY EYE SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
ABDOMINAL DISCOMFORT SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
DYSPEPSIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
GASTROOESOPHAGEAL REFLUX DISEASE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
LIP DRY SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
VOMITING SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
CHEST DISCOMFORT SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
FATIGUE SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
INFLUENZA LIKE ILLNESS SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
UPPER RESPIRATORY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
EXCORIATION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
FALL SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
VENOMOUS STING SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
BLOOD CREATININE INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
HEPATIC ENZYME INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
PLATELET COUNT INCREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
HYPERTRIGLYCERIDAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
ARTHRALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
MUSCLE FATIGUE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
MUSCULAR WEAKNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
MUSCULOSKELETAL STIFFNESS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
MYALGIA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
NECK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
PAIN IN EXTREMITY SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
POST HERPETIC NEURALGIA SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
SOMNOLENCE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
ANXIETY SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
PANIC ATTACK SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
DYSURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
URETERIC OBSTRUCTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
COUGH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
NASAL CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
NASAL DRYNESS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
OROPHARYNGEAL PAIN SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
DRY SKIN SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
INGROWING NAIL SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
PRURITUS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
RASH SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
SWELLING FACE SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
BLEEDING VARICOSE VEIN SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View