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 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
NCT ID:
NCT04552704
Description:
All Serious Adverse Events listed were unlikely related to study treatment. All adverse events listed were unrelated or unlikely related to study treatment, with the exception of alanine aminotransferase increased, aspartate aminotransferase increased, palor, diarrhea, nausea, vomiting, blood bicarbonate decreased, weight gain, anorexia, and hyponatremia, which were possibly or probably related to study treatment.
Frequency Threshold:
0
Time Frame:
Up to 60 days
Study:
NCT04552704
Study Brief:
CD24Fc for the Treatment of Immune Related Adverse Events in Patients With Advanced Solid Tumors, TIRAEC Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase I | Patients receive CD24Fc IV over 60 minutes on days 1, 14, and 28 with standard of care. | 1 | None | 1 | 3 | 3 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Odynophagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Blood bicarbonate decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Hepatic infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Infections and infestations - ascending thoracic aneurysm | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - BUN decreased | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Infections and infestations - tachypnea | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (5.0) | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| White blood cell decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Palor | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Heart burn | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (5.0) | View |
| Alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Elevated neutrophil | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| GGT elevated | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| WBC elevated | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (5.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| New lingular plueral-based opacity with increased FDG | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Possible new segment 2 metastatic lesion | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |
| Left vocal chord paralysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | View |