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 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
NCT ID:
NCT01119118
Description:
None
Frequency Threshold:
0
Time Frame:
14 months
Study:
NCT01119118
Study Brief:
ZD4054 With Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) for Prostate 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 |
|---|---|---|---|---|---|---|---|---|
| ZD4054 | ZD4054 + multimodal PET/MRI imaging | None | None | 4 | 6 | 6 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Supraventricular and nodal arrhythmia - Atrial fibrillation | None | Cardiac disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | None | General disorders | CTCAE (3.0) | View |
| Anorexia | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dehydration | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Diarrhea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Distension/bloating, abdominal | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Lymphopenia | None | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Cardiac Arrhythmia | None | Cardiac disorders | CTCAE (3.0) | View |
| Fatigue (asthenia, lethargy, malaise) | None | General disorders | CTCAE (3.0) | View |
| Fever | None | General disorders | CTCAE (3.0) | View |
| Insomnia | None | Psychiatric disorders | CTCAE (3.0) | View |
| Weight loss | None | Investigations | CTCAE (3.0) | View |
| Anorexia | None | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Diarrhea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Distension/bloating, abdominal | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Dry mouth/salivary gland (xerostomia) | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Gastritis | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Gastrointestinal - Other | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Nausea | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Taste alteration (dysgeusia) | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Vomiting | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hematoma | None | Vascular disorders | CTCAE (3.0) | View |
| Hemorrhage, GI - Upper GI NOS | None | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hemorrhage/Bleeding - Other | None | Vascular disorders | CTCAE (3.0) | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Bronchus | None | Infections and infestations | CTCAE (3.0) | View |
| Edema: limb | None | General disorders | CTCAE (3.0) | View |
| AST increased | None | Investigations | CTCAE (3.0) | View |
| Albumin, serum-low | None | Investigations | CTCAE (3.0) | View |
| Calcium, serum-low (hypocalcemia) | None | Investigations | CTCAE (3.0) | View |
| Sodium, serum-low (hyponatremia) | None | Investigations | CTCAE (3.0) | View |
| Muscle weakness | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Musculoskeletal/Soft Tissue - Other | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Mood alteration - Depression | None | Psychiatric disorders | CTCAE (3.0) | View |
| Neurology - Other | None | Psychiatric disorders | CTCAE (3.0) | View |
| Pain - Back | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Bone | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Extremity-limb | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Head/headache | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Pain - Joint | None | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Pulmonary/Upper Respiratory - Other | None | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Gynecomastia | None | Reproductive system and breast disorders | CTCAE (3.0) | View |