Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 10:34 PM
Ignite Modification Date: 2025-12-25 @ 8:06 PM
NCT ID: NCT01645735
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01645735
Study Brief: Evaluation of Ceftaroline Fosamil Versus a Comparator in Adult Subjects With Community-acquired Bacterial Pneumonia (CABP) With Risk for Methicillin-resistant Staphylococcus Aureus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ceftaroline Ceftaroline fosamil 600 mg IV over 60 minutes q8h None None 3 32 9 32 View
Ceftriaxone Plus Vancomycin Ceftriaxone 2 g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations None None 2 17 9 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Computerized tomogram thorax abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Neutrophil count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.1 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.1 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Edema Peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.1 View
Hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.1 View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16.1 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16.1 View