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 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
NCT ID:
NCT04400656
Description:
An AE is any untoward medical occurrence in a patient or clinical trial subject. For the purposes of the study, all AEs and SAEs were recorded throughout the study, however none are associated with the study itself as PROSPECT is an observational study only.
Frequency Threshold:
0
Time Frame:
23 months
Study:
NCT04400656
Study Brief:
PROState Pathway Embedded Comparative Trial
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Summary of Adverse Events | Summary of Adverse events from Feasibility Group | 0 | None | 3 | 139 | 78 | 139 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Incision and drainage, hospital admission | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| Left Ring Finger fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Psychosis | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hot flashes | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Abnormal gait | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Ataxia | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| COVID 19 infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Catheter pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Cognitive dysfunction | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Community acquired pneumonia | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (4.0) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Diarrhoea and vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Erectile Dysfunction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Faecal Frequency | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Flare of ulcerative Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Groin abscess | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Haematospermia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Headaches | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| High post void residual volumes | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Hip sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Inguinal Hernia repair | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| Intermittent Confusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Knee pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Left Ring Finger fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Leg pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Loss of balance | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Low urinary flow rate | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Lower urinary tract symptoms | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Nocturia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Perineal pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Poor urinary flow | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Post traumatic epilepsy | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Post traumatic stress disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Prostatitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Psychosis | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Recurrent Urinary Tract Infections | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Reduced ejaculatory volume | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Retinal detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| Right groin pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Sprained ankle | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Stress Urinary Incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Total hip arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (4.0) | View |
| Transient Ischaemic Attack | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Watery stool | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Weight gain | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Worsening shortness of breath | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| calf swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |