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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
NCT ID:
NCT02030067
Description:
None
Frequency Threshold:
5
Time Frame:
up to 224 days (8 cycles of treatment)
Study:
NCT02030067
Study Brief:
Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies
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 1 (Dose Escalation) 30 mg 3x/Week | RX-3117 30 mg administered 3 times/week | 0 | None | 0 | 1 | 1 | 1 | View |
| Phase 1 (Dose Escalation) 60 mg 3x/Week | RX-3117 60 mg administered 3 times/week | 0 | None | 1 | 1 | 1 | 1 | View |
| Phase 1 (Dose Escalation) 100 mg 3x/Week | RX-3117 100 mg administered 3 times/week | 0 | None | 0 | 3 | 3 | 3 | View |
| Phase 1 (Dose Escalation) 150 mg 3x/Week | RX-3117 150 mg administered 3 times/week | 0 | None | 0 | 3 | 3 | 3 | View |
| Phase 1 (Dose Escalation) 200 mg 3x/Week | RX-3117 200 mg administered 3 times/week | 0 | None | 0 | 3 | 3 | 3 | View |
| Phase 1 (Dose Escalation) 1000 mg 3x/Week | RX-3117 1000 mg administered 3 times/week | 0 | None | 1 | 3 | 3 | 3 | View |
| Phase 1 (Dose Escalation) 1500 mg 3x/Week | RX-3117 1500 mg administered 3 times/week | 0 | None | 0 | 4 | 4 | 4 | View |
| Phase 1 (Dose Escalation) 2000 mg 3x/Week | RX-3117 2000 mg administered 3 times/week | 0 | None | 2 | 6 | 6 | 6 | View |
| Phase 1 (Dose Escalation) 500 mg 5x/Week | RX-3117 500 mg administered 5 times/week | 0 | None | 2 | 3 | 3 | 3 | View |
| Phase 1 (Dose Escalation) 700 mg 5x/Week | RX-3117 700 mg administered 5 times/week | 1 | None | 5 | 11 | 11 | 11 | View |
| Phase 1 (Dose Escalation) 500 mg 7x/Week | RX-3117 500 mg administered 7 times/week | 0 | None | 1 | 3 | 3 | 3 | View |
| Phase 2 700 mg | RX-3117 700 mg administered 5 times/week | 8 | None | 29 | 80 | 78 | 80 | View |
| Phase 1 (Dose Escalation) 500 mg 3x/Week | RX-3117 500 mg administered 3 times/week | 0 | None | 0 | 3 | 0 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| large intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| peritonitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| hypoglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.1) | View |
| pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| pulmonary arterial hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| disease progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| local swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| neutropenic sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | View |
| ureteric cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | View |
| muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| cervical cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| hypophagia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| white blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| abnormal loss of weight | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.1) | View |
| epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| upper-airway cough syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |