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 @ 11:02 PM
Ignite Modification Date:
2025-12-25 @ 8:32 PM
NCT ID:
NCT01380769
Description:
None
Frequency Threshold:
3
Time Frame:
First dose to 30 days after the last dose of study drug
Study:
NCT01380769
Study Brief:
A Phase 2 Study of CRLX101(NLG207) in Patients With Advanced Non-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 |
|---|---|---|---|---|---|---|---|---|
| CRLX101+BSC | 15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor \[G-CSF\]) as required. | None | None | 12 | 97 | 76 | 97 | View |
| Best Supportive Care (BSC) Only | Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor \[G-CSF\]) as required. | None | None | 5 | 50 | 39 | 50 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, version 16.0 | View |
| anaphylatic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA, version 16.0 | View |
| bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, version 16.0 | View |
| lung abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, version 16.0 | View |
| liver function test | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, version 16.0 | View |
| psychotic disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA, version 16.0 | View |
| hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA, version 16.0 | View |
| pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | View |
| superior vena cava syndrome | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA, version 16.0 | View |
| atrial flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA, version 16.0 | View |
| cardiopulmonary failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA, version 16.0 | View |
| pyothorax | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, version 16.0 | View |
| esophagobronchial fistula | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | View |
| pulmonary hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | View |
| pulmonary thrombosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | View |
| cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | View |
| hemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA, version 16.0 | View |
| asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, version 16.0 | View |
| fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, version 16.0 | View |
| chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, version 16.0 | View |
| pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, version 16.0 | View |
| pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, version 16.0 | View |
| edema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA, version 16.0 | View |
| anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, version 16.0 | View |
| alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, version 16.0 | View |
| aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, version 16.0 | View |
| blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, version 16.0 | View |
| blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, version 16.0 | View |
| blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, version 16.0 | View |
| Eastern Cooperative Oncology Group performance status worsened | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA, version 16.0 | View |
| cystitis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA, version 16.0 | View |
| hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA, version 16.0 | View |
| leukocyturia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA, version 16.0 | View |
| proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA, version 16.0 | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, version 16.0 | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, version 16.0 | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA, version 16.0 | View |
| bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | View |
| pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | View |
| back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | View |
| respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, version 16.0 | View |
| sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA, version 16.0 | View |
| decreased appetitie | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA, version 16.0 | View |
| hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA, version 16.0 | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA, version 16.0 | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA, version 16.0 | View |
| superior vena cava syndrome | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA, version 16.0 | View |
| hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA, version 16.0 | View |
| non-small cell lung cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, version 16.0 | View |
| thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, version 16.0 | View |
| neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, version 16.0 | View |
| leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA, version 16.0 | View |
| neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA, version 16.0 | View |
| pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA, version 16.0 | View |
| hyperbilirubinemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA, version 16.0 | View |
| alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA, version 16.0 | View |