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 @ 2:28 PM
Ignite Modification Date:
2025-12-25 @ 1:03 PM
NCT ID:
NCT04635059
Description:
None
Frequency Threshold:
0
Time Frame:
2 Years
Study:
NCT04635059
Study Brief:
Pacritinib for Biochemical Relapse After Definitive Treatment 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 |
|---|---|---|---|---|---|---|---|---|
| Pacritinib | Pacritinib is an oral drug. Pacritinib: Pacritinib is an oral drug which will be taken daily on a 28-day cycle at a dose of 200 mg twice a day (BID). | 0 | None | 0 | 6 | 6 | 6 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v5.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Bladder spasm | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Belching | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v5.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v5.0 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE v5.0 | View |
| Heavy eyelids | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE v5.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE v5.0 | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v5.0 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Hyperlipidemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE v5.0 | View |
| Hyperuricemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE v5.0 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v5.0 | View |
| Muscle cramp | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Obesity | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE v5.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE v5.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE v5.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |
| Salivary duct inflammation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE v5.0 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE v5.0 | View |
| Actinic keratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE v5.0 | View |
| Sleep apnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Sore throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE v5.0 | View |
| Testosterone deficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE v5.0 | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE v5.0 | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE v5.0 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE v5.0 | View |
| White blood cell decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE v5.0 | View |