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 @ 3:48 PM
Ignite Modification Date:
2025-12-25 @ 1:56 PM
NCT ID:
NCT00197392
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00197392
Study Brief:
Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System
Event Groups(If Any):
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Death | None | Surgical and medical procedures | None | View |
| Sepsis secondary to pneumonia with complicating head injury | None | Infections and infestations | None | View |
| Respiratory culture positive for enterobateraerogenes | None | Infections and infestations | None | View |
| Brain Death | None | Nervous system disorders | None | View |
| Respiratory culture positive for staphylocccus aureus-oxacillan resistant (orsa) | None | Infections and infestations | None | View |
| Throat culture positive for enterobacter aerogenes | None | Infections and infestations | None | View |
| CSF positive for coccidiodes immitis | None | Infections and infestations | None | View |
| Respiratory culture positive for escherichia coli | None | Infections and infestations | None | View |
| Epidural hematoma at ventriculostomy site | None | Infections and infestations | None | View |
| CSF infection | None | Infections and infestations | None | View |
| Right intracerebral hemorhage | None | Cardiac disorders | None | View |
| Aseptic Inflammation | None | Infections and infestations | None | View |
| Ventriculitis | None | Nervous system disorders | None | View |
| Blood Culture Positive for Coagulase Negative Staphylococcus | None | Infections and infestations | None | View |
| Vasovagal Shock at EVD Explant | None | Nervous system disorders | None | View |
| Respiratory culture positive for staphylocccus | None | Infections and infestations | None | View |
| Respiratory culture positive for haemophilus influenzae | None | Infections and infestations | None | View |
| Nares culture positive for oxacillan resistant staphylocccus aureus | None | Infections and infestations | None | View |
| CSF culture positive for coagulase negative staphylococcus | None | Infections and infestations | None | View |
| CSF infection with secondary hydrocephalus | None | Infections and infestations | None | View |
| Meningitis | None | Infections and infestations | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood positive for streptococcus | None | Infections and infestations | None | View |
| CNS Infection | None | Infections and infestations | None | View |
| Coagulase negative staphylococcus in CSF | None | Infections and infestations | None | View |
| Confirmed dipthroid infection in CSF | None | Infections and infestations | None | View |
| CSF culture positive for coagulase negative staphylococcus | None | Infections and infestations | None | View |
| CSF Positive for propionibacterium | None | Infections and infestations | None | View |
| CSF infection - entermococcus faecacil acinetobacter banmanii | None | Infections and infestations | None | View |
| CSF Infection - pseudomonas | None | Infections and infestations | None | View |
| Catheter tip - cultutre positive for coagulase negative staphylococcus | None | Infections and infestations | None | View |
| Catheter occlusion due to hemorrhage | None | Vascular disorders | None | View |
| Increrased intra-cranial pressure | None | Nervous system disorders | None | View |
| Infection | None | Infections and infestations | None | View |
| Meningitis | None | Infections and infestations | None | View |
| Sputum culture positive with gram positive cocci & gram negative diplococci | None | Infections and infestations | None | View |
| Sputum positive for gram negative & gram positive rods | None | Infections and infestations | None | View |
| Sputum positive for staphylococcus | None | Infections and infestations | None | View |
| Stomach Ulcer | None | Gastrointestinal disorders | None | View |
| Trubid CSF | None | Surgical and medical procedures | None | View |
| Urine positive for escherichia coli | None | Infections and infestations | None | View |
| Vasovagal Shock | None | Nervous system disorders | None | View |
| Sputum Positive for Staphylococcus | None | Infections and infestations | None | View |