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 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
NCT ID:
NCT05754333
Description:
Participants at risk in ACM was collected and analyzed for all enrolled/randomized population. Participants at risk in Serious and Non serious adverse events were collected and analyzed in the SAF (dosed with ASP5354).
Frequency Threshold:
5
Time Frame:
All-cause mortality (ACM): From randomization up to 15 days (+ 10 days) AE- From first dose up to 15 days (+ 10 days)
Study:
NCT05754333
Study Brief:
A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Adult (Normal/Mild): White Light/Near-infrared Fluorescence | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. | 0 | None | 8 | 70 | 11 | 70 | View |
| Adult (Normal/Mild): White Light Only | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with normal renal function or mild renal impairment. WL was used to recognize/identify the ureter. | 0 | None | 4 | 13 | 5 | 13 | View |
| Adult (Moderate): White Light/Near-infrared Fluorescence | Pudexacianinium (3mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adult participants with moderate renal impairment. WL and NIR-F were used to recognize/identify the ureter. | 0 | None | 0 | 8 | 1 | 8 | View |
| Adolescent (Normal/Mild): WL/NIR-F | Pudexacianinium (3 mg) was administered as a single IV dose approximately 30 min before ureter visualization, on Day 1 in adolescent participants with normal renal function or mild renal impairment. WL and NIR-F were used to recognize/identify the ureter. | 0 | None | 0 | 14 | 7 | 14 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v27.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Anastomotic leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Postoperative ileus | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v27.0 | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v27.0 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v27.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v27.0 | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v27.0 | View |
| Pelvic haematoma | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v27.0 | View |
| Pelvic haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v27.0 | View |
| Pneumonitis aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v27.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v27.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v27.0 | View |
| Dilutional anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v27.0 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v27.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v27.0 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v27.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v27.0 | View |
| Glomerular filtration rate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v27.0 | View |
| Chromaturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v27.0 | View |
| Loss of bladder sensation | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v27.0 | View |