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 @ 4:32 AM
Ignite Modification Date: 2025-12-26 @ 3:34 AM
NCT ID: NCT02667418
Description: None
Frequency Threshold: 1
Time Frame: 8 years, 6 months
Study: NCT02667418
Study Brief: Optimal Treatment for Recurrent Clostridium Difficile
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fidaxomicin Standard 10-day fidaxomicin treatment for Clostridium difficile Fidaxomicin: 200 mg PO twice daily for 10 days 8 None 34 102 7 102 View
Vancomycin T/P Standard 10-day vancomycin treatment followed by taper and pulse vancomycin treatment for Clostridium difficile Vancomycin with Taper/Pulse: 125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days 2 None 30 100 15 100 View
Vancomycin Standard 10-day vancomycin treatment for Clostridium difficile Vancomycin: 125 mg PO for times daily for 10 days 3 None 27 100 12 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mycardinal infection SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper Gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
chest pain SYSTEMATIC_ASSESSMENT General disorders None View
complication associated with device SYSTEMATIC_ASSESSMENT General disorders None View
death SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Physical deconditioning SYSTEMATIC_ASSESSMENT General disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac valve vegetation SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridial sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Alcohol poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Renal lymphocele SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperkaliemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypervolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Alcohol abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Alcohol withdrawal SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Substance abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
End stage renal disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chronic Obstructive Pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Homeless SYSTEMATIC_ASSESSMENT Social circumstances None View
Alcohol detoxification SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Intraocular Lens Implant SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Knee Arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Arteriovenous fistula operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
Metastases to bone SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Myelodysplastic syndrome SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Colon cancer stage IV SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Diffuse large B-cell lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Catheterisation cardiac SYSTEMATIC_ASSESSMENT Investigations None View
Device occlusion SYSTEMATIC_ASSESSMENT Product Issues None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sepsis syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutrophil count decrease SYSTEMATIC_ASSESSMENT Investigations None View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Emotional distress SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Clostridioide difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count SYSTEMATIC_ASSESSMENT Investigations None View
White blood cell count SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase SYSTEMATIC_ASSESSMENT Investigations None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View