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 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:23 PM
NCT ID:
NCT04397757
Description:
41 subjects were enrolled in the treatment arm; 1 subject withdrew consent prior to initiate any research activities; Only 40 were placed at risk.
Frequency Threshold:
5
Time Frame:
Up to Study Day 60
Study:
NCT04397757
Study Brief:
COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment | On Day 1 subjects receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19 followed by standard of care | 3 | None | 13 | 40 | 15 | 40 | View |
| Control | Standard of care treatment administered only | 11 | None | 19 | 39 | 20 | 39 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute CNS Ischemia | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | DAIDS 2.1 | View |
| Altered Mental Status | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | DAIDS 2.1 | View |
| Arrhythmia (by ECG or physical examination) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | DAIDS 2.1 | View |
| Creatinine High | NON_SYSTEMATIC_ASSESSMENT | Investigations | DAIDS 2.1 | View |
| Glucose low | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | DAIDS 2.1 | View |
| Dyspnea or Respiratory Distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | DAIDS 2.1 | View |
| Hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | DAIDS 2.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | DAIDS 2.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | DAIDS 2.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | DAIDS 2.1 | View |
| Embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | DAIDS 2.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | DAIDS 2.1 | View |
| Neurosensory alteration | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | DAIDS 2.1 | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | DAIDS 2.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | DAIDS 2.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | DAIDS 2.1 | View |
| Albumin, Low | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | DAIDS 2.1 | View |
| Alkalosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | DAIDS 2.1 | View |
| Altered Mental Status | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | DAIDS 2.1 | View |
| Arrhythmia (by ECG or physical examination) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | DAIDS 2.1 | View |
| AST, High | NON_SYSTEMATIC_ASSESSMENT | Investigations | DAIDS 2.1 | View |
| Blood Pressure Abnormalities Hypertension (with the lowest reading taken after repeat testing durin | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | DAIDS 2.1 | View |
| Creatinine, High | NON_SYSTEMATIC_ASSESSMENT | Investigations | DAIDS 2.1 | View |
| Dyspnea or Respiratory Distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | DAIDS 2.1 | View |
| Fever (non-axillary temperatures only) | NON_SYSTEMATIC_ASSESSMENT | General disorders | DAIDS 2.1 | View |
| Gastrointestinal Bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | DAIDS 2.1 | View |
| Glucose (mg/dL; mmol/L) Fasting, High | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | DAIDS 2.1 | View |
| Hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | DAIDS 2.1 | View |
| Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (female only) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | DAIDS 2.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | DAIDS 2.1 | View |
| Platelets, Decreased | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | DAIDS 2.1 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | DAIDS 2.1 | View |
| Acute CNS Ischemia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | DAIDS 2.1 | View |
| ALT High | NON_SYSTEMATIC_ASSESSMENT | Investigations | DAIDS 2.1 | View |
| Calcium, Low (mg/dL; mmol/L) >= 7 days of age | NON_SYSTEMATIC_ASSESSMENT | Investigations | DAIDS 2.1 | View |
| Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (male only) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | DAIDS 2.1 | View |
| Pain (not associated with study agent injections and not specified elsewhere) | NON_SYSTEMATIC_ASSESSMENT | General disorders | DAIDS 2.1 | View |
| Pruritus (without skin lesions) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | DAIDS 2.1 | View |
| Thrombosis or Embolism Report only one | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | DAIDS 2.1 | View |