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 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
NCT ID:
NCT01848756
Description:
Regular Investigator Assessment including patient volunteered reports
Frequency Threshold:
5
Time Frame:
From patient screening to removal from study, average time on study 49+/-16 days
Study:
NCT01848756
Study Brief:
Safety and Efficacy of SNX-5422 in Human Epidermal Growth Factor Receptor 2 (HER2) Positive Cancers
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| SNX-5422 | Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety. SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. | None | None | 8 | 15 | 15 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V15.0 | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA V15.0 | View |
| Renal Failure Acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA V15.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V15.0 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V15.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V15.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V15.0 | View |
| Cardiac Tamponade | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA V15.0 | View |
| Pericardial Effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA V15.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V15.0 | View |
| Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA V15.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V15.0 | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA V15.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V15.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V15.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA V15.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V15.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA V15.0 | View |
| Vision Blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA V15.0 | View |
| Renal Failure Acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA V15.0 | View |
| Rash Maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA V15.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V15.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V15.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V15.0 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V15.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V15.0 | View |
| Dry Mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V15.0 | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA V15.0 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V15.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V15.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V15.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V15.0 | View |
| Hyperphosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V15.0 | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V15.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V15.0 | View |
| hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA V15.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V15.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V15.0 | View |
| Mucosal Inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA V15.0 | View |
| Aspartate Aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V15.0 | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V15.0 | View |
| Blood Alkaline Phosphatase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V15.0 | View |
| Activated Partial Thromboplastin Time Prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V15.0 | View |
| Blood Cholesterol Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V15.0 | View |
| Blood Creatinine Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V15.0 | View |
| Lymphocyte Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V15.0 | View |
| White Blood Cell Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA V15.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA V15.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA V15.0 | View |