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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Reflection Ceramic-Ceramic Hip System (IP) | Investigational: Reflection Ceramic-Ceramic Hip System. Ceramic femoral head component and the ceramic acetabular cup insert are composed of Biolox forte aluminum oxide material. Reflection Ceramic-Ceramic Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem. | 18 | None | 18 | 308 | 0 | 308 | View |
| Reflection FSO V (5 Hole) (Control) | Control: Reflection FSO V (5 hole). Acetabular shell with a ultra high molecular weight polyethylene insert and an alumina ceramic femoral head with a Synergy or Spectron EF femoral stem. The Synergy femoral stem are composed of implant grade titanium while the Spectron EF stem is composed of implant grade cobalt chrome. Reflection FSO V Total Hip Replacement: Intervention: all patients in study required (intervention) a total hip replacement, and were randomized to receive either the (Study Device)Reflection Ceramic Acetabular System or the(Control Device) Reflection FSO V (5 hole)acetabular system. Both arms received either a Synergy porous coated or Spectron EF stem. | 7 | None | 7 | 148 | 0 | 148 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Complications related to an infection | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | Proprietary system | View |
| Injuries sustained during a house fire | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Proprietary system | View |
| Found during a death index search, reason unknown | SYSTEMATIC_ASSESSMENT | General disorders | Proprietary system | View |
| Unknown, not reported by site | SYSTEMATIC_ASSESSMENT | General disorders | Proprietary system | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | Proprietary system | View |
| Emphysema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | Proprietary system | View |
| Heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Proprietary system | View |
| Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Proprietary system | View |
| Myelodysplastic leukemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Proprietary system | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Proprietary system | View |