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 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
NCT ID:
NCT02020135
Description:
None
Frequency Threshold:
5.0
Time Frame:
25 weeks
Study:
NCT02020135
Study Brief:
An Open-label Extension Study of PSMA ADC 2301 in mCRPC
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| PSMA ADC Chemotherapy-experienced | The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation). Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required. | None | None | 1 | 6 | 6 | 6 | View |
| PSMA ADC Chemotherapy-naive | The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it. Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required. | None | None | 0 | 3 | 3 | 3 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA®, Version 15 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA®, Version 15 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA®, Version 15 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA®, Version 15 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA®, Version 15 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA®, Version 15 | View |
| Arrythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA®, Version 15 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA®, Version 15 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA®, Version 15 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA®, Version 15 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA®, Version 15 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA®, Version 15 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA®, Version 15 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA®, Version 15 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA®, Version 15 | View |
| Gravitational edema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA®, Version 15 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA®, Version 15 | View |
| Peripheral edema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA®, Version 15 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA®, Version 15 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA®, Version 15 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA®, Version 15 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA®, Version 15 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA®, Version 15 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA®, Version 15 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA®, Version 15 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA®, Version 15 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA®, Version 15 | View |
| Peripheral neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA®, Version 15 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA®, Version 15 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA®, Version 15 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA®, Version 15 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA®, Version 15 | View |