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 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
NCT ID:
NCT01737502
Description:
None
Frequency Threshold:
0
Time Frame:
5 years
Study:
NCT01737502
Study Brief:
Sirolimus and Auranofin in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer or Small Cell Lung Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dose Level 0 | Patients receive 3mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. * Auranofin: Given PO * Sirolimus: Given PO * Laboratory Biomarker Analysis: Correlative studies * Pharmacological Study: Correlative studies | 1 | None | 2 | 3 | 3 | 3 | View |
| Dose Level 1 | Patients receive 6mg auranofin PO on days 1-28 and sirolimus PO on days 1-28 (days 8-28 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. * Auranofin: Given PO * Sirolimus: Given PO * Laboratory Biomarker Analysis: Correlative studies * Pharmacological Study: Correlative studies | 3 | None | 8 | 26 | 23 | 26 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Bladder infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.1 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.1 | View |
| Thrombotic thrombocytopenic purpura | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.1 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.1 | View |
| Bladder infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Bronchial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Infections and infestations - Oth spec | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Papulopustular rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| Cholesterol high | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.1 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| Hypertriglyceridemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.1 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.1 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.1 | View |