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:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
NCT ID:
NCT03095612
Description:
No data collected or analyzed for monotherapy as the study was halted early due to funding.
Frequency Threshold:
5
Time Frame:
Adverse event data was collected for a period of time over 4 years, 7 months.
Study:
NCT03095612
Study Brief:
Phase 1/2 Trial of Selinexor (KPT-330) With Docetaxel for Non-small Cell Lung Cancer (NSCLC)
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 Escalation: Selinexor 60mg + Docetaxel 75mg/m2 | Selinexor will be administered once weekly starting one week before chemotherapy initiation in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Selinexor dose escalation: 60, 80, 100 mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks. Selinexor: Selinexor once weekly oral or twice weekly oral Docetaxel: Docetaxel once every 3 weeks (75 mg/m2 IV) | 0 | None | 0 | 3 | 3 | 3 | View |
| Dose Escalation: Selinexor 80mg + Docetaxel 75mg/m2 | Selinexor will be administered once weekly starting one week before chemotherapy initiation in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Selinexor dose escalation: 60, 80, 100 mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks. Selinexor: Selinexor once weekly oral or twice weekly oral Docetaxel: Docetaxel once every 3 weeks (75 mg/m2 IV) | 0 | None | 4 | 4 | 4 | 4 | View |
| Dose Escalation:Selinexor 100mg + Docetaxel 75mg/m2 | Selinexor will be administered once weekly starting one week before chemotherapy initiation in combination with docetaxel. Docetaxel will be given once every 3 weeks. Treatment will be administered in 21-day cycles. Selinexor dose escalation: 60, 80, 100 mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks. Selinexor: Selinexor once weekly oral or twice weekly oral Docetaxel: Docetaxel once every 3 weeks (75 mg/m2 IV) | 0 | None | 0 | 0 | 0 | 0 | View |
| Dose Expansion: Selinexor 60 mg + Docetaxel 75mg/m2 | Selinexor dose escalation: 60mg once weekly. Docetaxel 75 mg/m2 IV, 60 every 3 weeks. | 0 | None | 0 | 33 | 33 | 33 | View |
| Selinexor 40mg Monotherapy | For the selinexor monotherapy cohort, 6 patients each will be treated in two dosing cohorts (weekly and biweekly). Selinexor once weekly oral (40mg, 60mg, 80mg) OR Selinexor twice weekly oral (60mg, 40mg, 60mg weekly). | 0 | None | 0 | 0 | 0 | 0 | View |
| Selinexor 60mg Monotherapy | For the selinexor monotherapy cohort, 6 patients each will be treated in two dosing cohorts (weekly and biweekly). Selinexor once weekly oral (40mg, 60mg, 80mg) OR Selinexor twice weekly oral (60mg, 40mg, 60mg weekly). | 0 | None | 0 | 0 | 0 | 0 | View |
| Selinexor 80mg Monotherapy | For the selinexor monotherapy cohort, 6 patients each will be treated in two dosing cohorts (weekly and biweekly). Selinexor once weekly oral (40mg, 60mg, 80mg) OR Selinexor twice weekly oral (60mg, 40mg, 60mg weekly). | 0 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE v4.03 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.03 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE v4.03 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE v4.03 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE v4.03 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE v4.03 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE v4.03 | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE v4.03 | View |
| Head Laceration | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE v4.03 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE v4.03 | View |
| Platelets Decreased | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE v4.03 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE v4.03 | View |
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE v4.03 | View |
| hypoxia | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE v4.03 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE v4.03 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE v4.03 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE v4.03 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE v4.03 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE v4.03 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE v4.03 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE v4.03 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE v4.03 | View |
| Lymphocytes Decreased/Lymphopenia/Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE v4.03 | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE v4.03 | View |
| Edema | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE v4.03 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE v4.03 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE v4.03 | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE v4.03 | View |
| Platelet Counts Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE v4.03 | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE v4.03 | View |
| Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE v4.03 | View |
| Mucositis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE v4.03 | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE v4.03 | View |
| Generalized muscle weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE v4.03 | View |
| Confusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | NCI CTCAE v4.03 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.03 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE v4.03 | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE v4.03 | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE v4.03 | View |
| Creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE v4.03 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE v4.03 | View |
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE v4.03 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.03 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE v4.03 | View |
| Hypophosphatemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE v4.03 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE v4.03 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.03 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.03 | View |
| Lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE v4.03 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE v4.03 | View |
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE v4.03 | View |
| Hemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.03 | View |
| Febrile Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE v4.03 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE v4.03 | View |
| Hypercalcemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE v4.03 | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.03 | View |