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 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
NCT ID:
NCT00006903
Description:
The frequencies of maximum grade of serious adverse event or, for other adverse events, treatment-related adverse events by category or specific term occurring during treatment and up to 30 days after stopping the study treatment are reported.
Other Adverse Events reported are Grade 2 or higher.
Frequency Threshold:
0
Time Frame:
Study treatment, and up to 30 days after stopping study treatment.
Study:
NCT00006903
Study Brief:
Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial 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 |
|---|---|---|---|---|---|---|---|---|
| Faslodex | Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy. Includes both Estrogen Receptor Positive and Estrogen Receptor Negative participants. | None | None | 11 | 53 | 28 | 53 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Death no ctcae term - disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Death no ctcae term - death nos | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Distention | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Obstruction, gi - small bowel nos | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage, gi - stomach | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Hemorrhage/pulmonary - respiratory tract | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Infection - other | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pain: abdominal pain nos | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pain: pelvis | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Thrombosis/thrombus/embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Auditory | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (3.0) | View |
| Constitutional | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Injection Site Reaction | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Hot Flashes/Flushes | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (3.0) | View |
| Gastrointestinal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Infection/Fever | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Metabolic | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Musculoskeletal | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Neurologic | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Ocular/Visual | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Thrombosis/embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |