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 @ 6:26 PM
Ignite Modification Date:
2025-12-25 @ 3:56 PM
NCT ID:
NCT04503668
Description:
Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints
Frequency Threshold:
5
Time Frame:
All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints
Study:
NCT04503668
Study Brief:
Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Nk1-RA | Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Neurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5 | 4 | None | 3 | 27 | 24 | 27 | View |
| Olanzapine | Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles. Ondansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy Dexamethasone: 20 mg IV on day 1 pre-chemotherapy Olanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night) Compazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5 | 6 | None | 5 | 24 | 23 | 24 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 5.0 | View |
| fall | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 5.0 | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 5.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| anemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | View |
| debulking surgery | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 5.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| abdominal cramping | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| abdominal distention | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| alopecia | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 5.0 | View |
| anemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| anorexia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE version 5.0 | View |
| arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 5.0 | View |
| aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 5.0 | View |
| bloating | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| cognitive disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 5.0 | View |
| constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| dizziness | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 5.0 | View |
| dry mouth | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 5.0 | View |
| dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 5.0 | View |
| edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 5.0 | View |
| facial flushing | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 5.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 5.0 | View |
| headache | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 5.0 | View |
| hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| hypocalcemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| hypomagnesemia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE version 5.0 | View |
| lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE version 5.0 | View |
| nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 5.0 | View |
| neutropenia | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 5.0 | View |
| platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |
| presyncope | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE version 5.0 | View |
| rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 5.0 | View |
| vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 5.0 | View |
| white blood cell decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAE version 5.0 | View |