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 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
NCT ID:
NCT03300505
Description:
Only a single participant was included in the Dose Level 1 arm and data are not reported publicly to protect participant confidentiality
Frequency Threshold:
0
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; additionally, any serious adverse event occurring more than 30 days after the last study treatment if considered to be related to the study treatment. Data was collected during a 3.5 year period.
Study:
NCT03300505
Study Brief:
ARRx in Combination With Enzalutamide in Metastatic Castration Resistant 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 |
|---|---|---|---|---|---|---|---|---|
| Level 1 | Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity. ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS | 0 | None | 0 | 1 | 0 | 0 | View |
| Level 2 | Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity. ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS | 1 | None | 2 | 5 | 5 | 5 | View |
| Level 3 | Phase 1b: All registered subjects will be treated with ARRx (ASO) in combination with enzalutamide. ARRx will be given intravenously on Days 1, 4, 8, 11, 15 on cycle 1, then on days 1, 8, 15 in subsequent 21-day cycles. Enzalutamide will be taken daily in 21 day cycles starting Day 1 of cycle 1. Treatment will continue until clinical or radiologic progression or unacceptable toxicity. ARRx: Given intravenously (IV) Enzalutamide: Given by mouth (PO) Dose Level 1: 600 mg IONIS Dose Level 2: 750 mg IONIS Dose Level 3: 900 mg IONIS | 0 | None | 1 | 3 | 3 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Acute Kidney Injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Thromboembolic Event | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Blood lactate dehydrogenase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Bruising | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Bullous dermatitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Dyspnea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Edema limbs | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Infusion related reaction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Muscle weakness lower limb | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Paresthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Thromboembolic event | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Weight loss | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Flu like symptoms | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hot flashes | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hyperkalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hypoalbuminemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |