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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
NCT ID:
NCT03081858
Description:
The severity and frequency of AEs were assessed following administration and defined per the NCI CTCAE Version 5.0. The study was not designed or powered to support formal comparisons of AEs across individual dose levels, so the Statistical Analysis Plan pre-specified the reporting of AEs grouped by each cohort within part 1 and part 2. The continued tracking of AEs and recording of new/continuing SAEs is pre-specified to be for all participants in Part 3 as outlined above.
Frequency Threshold:
1
Time Frame:
For Part 1 patients, the time period for adverse event collection was 16 weeks after the first treatment. For Part 2 patients, the time period for adverse event collection was 13 Weeks after the first treatment. During part 3, AEs continued from part 1 or part 2 will be followed until resolution, stabilization, or end of study, but no new AEs will be recorded (excepts SAEs). So, the total time frame was 2 years from the first treatment.
Study:
NCT03081858
Study Brief:
Proliposomal Intravesical Paclitaxel for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder 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 |
|---|---|---|---|---|---|---|---|---|
| TSD-001 Administration Part 1, Cohort 1 | In part 1, these subjects were treated in a planned six-dose escalation of TSD-001 every 2 weeks via the intravesical route until DLT (establishing MTD) or until MDD was reached. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more was acceptable, depending on the subject's tolerability of the procedure). | 0 | None | 0 | 3 | 3 | 3 | View |
| TSD-001 Administration Part 1, Cohort 2 | In part 1, these subjects were treated in a planned six-dose escalation of TSD-001 every 2 weeks via the intravesical route until DLT (establishing MTD) or until MDD was reached. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more was acceptable, depending on the subject's tolerability of the procedure). | 0 | None | 0 | 3 | 2 | 3 | View |
| TSD-001 Administration Part 2, Cohort 1 | In part 2, cohort 1, the dose administered was planned as the MDD established in part 1, and provided weekly via the intravesical route for six doses. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). | 0 | None | 0 | 6 | 6 | 6 | View |
| TSD-001 Administration Part 2, Cohort 2 | In part 2, cohort 2, the dose administered was planned as the MDD established in part 1, and provided weekly via the intravesical route for eight doses. TSD-001 was planned to be retained in the bladder for 2 hours (1 hour or more will be acceptable, depending on the subject's tolerability of the procedure). | 0 | None | 1 | 3 | 2 | 3 | View |
| TD-001 Part 3 (Long-term Surveillance) | All subjects in part 1 and part 2, were eligible for continued surveillance for safety event for up to 2 years after initial intravesical exposure to TSD-001. This observational study of safety (all subjects) and recurrence (Part 1 subjects only) followed standard of care cystoscopy bladder tumor follow-up every 3 months. During this time, only SAEs and those AEs related to SAEs were tracked and recorded. | 0 | None | 1 | 10 | 1 | 10 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA,Version 20.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA,Version 20.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA,Version 20.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA,Version 20.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA,Version 20.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA,Version 20.1 | View |
| Fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA,Version 20.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA,Version 20.1 | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA,Version 20.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA,Version 20.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA,Version 20.1 | View |
| Post procedural haematuria | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA,Version 20.1 | View |
| Blood urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA,Version 20.1 | View |
| Increased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA,Version 20.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA,Version 20.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA,Version 20.1 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA,Version 20.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA,Version 20.1 | View |
| Hypersomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA,Version 20.1 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA,Version 20.1 | View |
| Anorgasmia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA,Version 20.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA,Version 20.1 | View |
| Bladder discomfort | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA,Version 20.1 | View |
| Calculus bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA,Version 20.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA,Version 20.1 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA,Version 20.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA,Version 20.1 | View |
| Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA,Version 20.1 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA,Version 20.1 | View |
| Extraperitoneal Bladder Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA,Version 20.1 | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA,Version 20.1 | View |