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:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
NCT ID:
NCT04479358
Description:
None
Frequency Threshold:
5
Time Frame:
28 days
Study:
NCT04479358
Study Brief:
Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of Care | Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg). Standard of Care: Tocilizumab 400mg or 8mg/kg | 0 | None | 0 | 3 | 3 | 3 | View |
| Sub-study B, Tocilizumab 40mg | Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg | 0 | None | 0 | 3 | 3 | 3 | View |
| Sub-study B, Tocilizumab 120mg | Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg | 0 | None | 0 | 1 | 1 | 1 | View |
| Sub-study A, Tocilizumab 40mg | Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg. Tocilizumab: Tocilizumab 40mg | 3 | None | 0 | 25 | 22 | 25 | View |
| Sub-study A, Tocilizumab 120mg | Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg. Tocilizumab: Tocilizumab 120mg | 0 | None | 0 | 25 | 21 | 25 | View |
| Sub-study A, Tocilizumab-Free Standard of Care | Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab. Standard of Care: Tocilizumab-Free Standard of Care | 1 | None | 0 | 26 | 23 | 26 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Ventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac disorders - other | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| General disorders and administration site conditions | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Infections and infestations | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Alanine aminotransferase | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Aspartate aminotransferase | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| White blood cell decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Investigations - other | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Renal and urinary disorders - other | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory, thoracic and mediastinal disorders - other | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Thromboembolic event | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Sinus bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypernatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |