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 @ 5:19 PM
Ignite Modification Date:
2025-12-25 @ 2:55 PM
NCT ID:
NCT02384850
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse Events were monitored from the date of informed consent until 30 days after the last dose of study medication (end of treatment visit). Patients who discontinued for reasons other than withdrawal of consent were followed for a maximum of 24 months for progression-free survival and overall survival, so deaths were monitored for up to 2 years for patients in follow-up.
Study:
NCT02384850
Study Brief:
Phase 1 Trial To Evaluate mFOLFOX6 With Selinexor In Patients With Metastatic Colorectal 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 |
|---|---|---|---|---|---|---|---|---|
| Selinexor 40mg + mFOLFOX6 | Selinexor: Dose Level 1: 40 mg on day 1, 3 and 8 in a two-weeks cycle. Oxaliplatin: 85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle 5-FU: 400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3 Folinic Acid: 400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle | 0 | None | 2 | 4 | 4 | 4 | View |
| Selinexor 20mg + mFOLFOX6 | Selinexor: Dose Level -1: 20 mg on day 1, 3 and 8 in a two-weeks cycle. Oxaliplatin: 85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle 5-FU: 400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3 Folinic Acid: 400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle | 2 | None | 3 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| HYPERGLYCEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC AE v4.03 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC AE v4.03 | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC AE v4.03 | View |
| ACUTE CORONARY SYNDROME | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTC AE v4.03 | View |
| GENERAL MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC AE v4.03 | View |
| SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC AE v4.03 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC AE v4.03 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC AE v4.03 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTC AE v4.03 | View |
| DIARRHEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC AE v4.03 | View |
| ANEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTC AE v4.03 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC AE v4.03 | View |
| HYPONATREMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC AE v4.03 | View |
| ANOREXIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC AE v4.03 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC AE v4.03 | View |
| INFECTION OF UNKNOWN ORIGIN | SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTC AE v4.03 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC AE v4.03 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC AE v4.03 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTC AE v4.03 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC AE v4.03 | View |
| BODY PAIN | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC AE v4.03 | View |
| DOUBLE VISION | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTC AE v4.03 | View |
| SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC AE v4.03 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC AE v4.03 | View |
| HEARING IMPAIRMENT | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | NCI CTC AE v4.03 | View |
| DYSPNEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTC AE v4.03 | View |
| POLYNEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC AE v4.03 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTC AE v4.03 | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | NCI CTC AE v4.03 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTC AE v4.03 | View |
| WEIGHT LOSS | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTC AE v4.03 | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTC AE v4.03 | View |
| PAIN INGUINAL RIGHT | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTC AE v4.03 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTC AE v4.03 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | NCI CTC AE v4.03 | View |
| BLURRED VISION | SYSTEMATIC_ASSESSMENT | Eye disorders | NCI CTC AE v4.03 | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTC AE v4.03 | View |
| FLU-LIKE SYMPTOMS | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC AE v4.03 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTC AE v4.03 | View |
| HYPOKALEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTC AE v4.03 | View |