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 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
NCT ID:
NCT02009332
Description:
None
Frequency Threshold:
0
Time Frame:
From the signing of the informed consent through the 6-week induction treatment period and the 30-day follow-up period (up to 2.5 months). An additional 4 months for patients who received 3 additional monthly maintenance treatments (up to 6.5 months).
Study:
NCT02009332
Study Brief:
Phase 1/2 Study of ABI-009 in Nonmuscle 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 |
|---|---|---|---|---|---|---|---|---|
| Phase 1: ABI-009 100 mg 2×/Week | Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks | 0 | None | 0 | 1 | 1 | 1 | View |
| Phase 1: ABI-009 300 mg/Week | Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks | 0 | None | 0 | 3 | 3 | 3 | View |
| Phase 1: ABI-009 400 mg/Week | Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks | 0 | None | 0 | 4 | 3 | 4 | View |
| Phase 2: ABI-009 400 mg/Week + Gemcitabine 2000 mg/Week | ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 1 hour, once per week for 6 weeks; Gemcitabine, 2000 mg in 100 mL saline, administered intravesically after voiding of ABI-009 and retained for 1 hour, once per week for 6 weeks | 0 | None | 0 | 6 | 6 | 6 | View |
| Phase 1: ABI-009 100 mg/Week | Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks | 0 | None | 0 | 3 | 2 | 3 | View |
| Phase 1: ABI-009 200 mg/Week | Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks | 0 | None | 0 | 4 | 1 | 4 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE v4.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE v4.0 | View |
| Penis Lesion/rash | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI CTCAE v4.0 | View |
| Increased frequency and urgency of urination | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE v4.0 | View |
| Abnormal urine analysis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE v4.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE v4.0 | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE v4.0 | View |
| Inguinal and thigh pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE v4.0 | View |
| Kidney stone | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE v4.0 | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | NCI CTCAE v4.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE v4.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE v4.0 | View |
| Decreased absolute neutrophil | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE v4.0 | View |
| Decreased white blood cell | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE v4.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE v4.0 | View |
| Elevated bilirubin | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | NCI CTCAE v4.0 | View |
| Elevated creatinine | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE v4.0 | View |
| Bladder spasm | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE v4.0 | View |
| Urinary tract pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE v4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE v4.0 | View |
| Worsening of congestive heart failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | NCI CTCAE v4.0 | View |
| Worsening of chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE v4.0 | View |
| Worsening of edema of extremities | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE v4.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE v4.0 | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE v4.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE v4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE v4.0 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE v4.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE v4.0 | View |
| Pulmonary edema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE v4.0 | View |