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 @ 10:42 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
NCT ID:
NCT01011335
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01011335
Study Brief:
Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Bivalent rAT/rLukS 10µg Dose | None | None | None | 0 | 12 | 7 | 12 | View |
| Bivalent rAT/rLukS 25µg Dose | None | None | None | 1 | 12 | 8 | 12 | View |
| Monovalent rAT 10µg Dose | None | None | None | 0 | 11 | 7 | 11 | View |
| Monovalent rAT 25µg Dose | None | None | None | 0 | 12 | 10 | 12 | View |
| Monovalent rAT 50µg Dose | None | None | None | 0 | 12 | 10 | 12 | View |
| Monovalent rAT 100µg Dose | None | None | None | 0 | 12 | 9 | 12 | View |
| Monovalent rLukS 10µg Dose | None | None | None | 0 | 13 | 9 | 13 | View |
| Monovalent rLukS 25µg Dose | None | None | None | 0 | 12 | 12 | 12 | View |
| Monovalent rLukS 50µg Dose | None | None | None | 1 | 12 | 9 | 12 | View |
| Monovalent rLukS 100µg Dose | None | None | None | 0 | 12 | 10 | 12 | View |
| Bivalent rAT/rLukS 50µg Dose | None | None | None | 2 | 12 | 12 | 12 | View |
| Alum Placebo | None | None | None | 0 | 22 | 19 | 22 | View |
| Normal Saline Placebo | None | None | None | 1 | 22 | 16 | 22 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alcoholism | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Astrocytoma Malignant | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Non-cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| ALT increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Blood glucose decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Haemoglobin abnormal | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| AST increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Blood LDH increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| WBC count increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Blood sodium increased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Respiratory tract congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Protein urine present | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| GERD | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Injection site swelling | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |