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 @ 3:15 PM
Ignite Modification Date: 2025-12-25 @ 1:37 PM
NCT ID: NCT01808092
Description: AEs spontaneously reported by the patient or care provider or reported in response to open question from the study center personnel, or revealed by observation were to be collected and recorded in the eCRF. Summary tables include all randomized patients but 62 MSRIBorig patients and 9 patients who didn't receive study treatment after randomization.
Frequency Threshold: 2
Time Frame: Nonserious AEs and SAEs are collected for each patient from date when informed consent is obtained until the date of final protocol follow-up, study withdrawal or date of death from any cause, whichever came first, assessed up to 28 days.
Study: NCT01808092
Study Brief: A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CAZ-AVI 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem None None 75 405 198 405 View
Meropenem meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo None None 54 403 195 403 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Acute left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac asthma SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cardiovascular insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Cyanosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.1 View
Diabetes insipidus SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 18.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Duodenal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Intentional medical device removal by patient SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
Subacute hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 18.1 View
CNS ventriculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Device related sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Diabetic foot infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Enterobacter pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
HIV infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Infectious pleural effusion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pulmonary sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastrointestinal anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Tracheostomy malfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Weaning failure SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Myopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Bronchioloalveolar carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Lung neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Metastases to peritoneum SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Rectal cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 18.1 View
Autonomic nervous system imbalance SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Brachial plexopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Bronchial secretion retention SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Bronchoplegia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Obstructive airways disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 18.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View