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 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
NCT ID:
NCT02849418
Description:
SAEs and non-SAEs were reported for SPDB Population (Treatment Cycle1:Placebo and GSK1358820 200 U) and Safety Population (SP) 1 (Treatment Cycle2:Placebo/GSK1358820 200 U), SP 2 (Treatment Cycle 2:GSK1358820 200 U/GSK1358820 200 U and Treatment Cycle 3: Placebo/GSK1358820 200 U) and SP 3 (Treatment Cycle3:GSK1358820 200 U/GSK1358820 200 U) .
Frequency Threshold:
5
Time Frame:
SAEs and Non-SAEs were collected up to 48 weeks in Treatment Cycle 1 and up to Week 48 (48 weeks after 1st treatment) in Treatment Cycles 2 and 3
Study:
NCT02849418
Study Brief:
Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment Cycle 3: Placebo / GSK1358820 200 U | Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2) and further received re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3). | 0 | None | 0 | 5 | 4 | 5 | View |
| Treatment Cycle 1: Placebo | Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). | 0 | None | 1 | 10 | 5 | 10 | View |
| Treatment Cycle 1: GSK1358820 200U | Participants received a single (double-blind) dose of GSK1358820 200 U injections (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). | 0 | None | 1 | 11 | 8 | 11 | View |
| Treatment Cycle 2: Placebo / GSK1358820 200 U | Participants received a single (double-blind) treatment with Placebo (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants meeting the re-treatment criteria received a single GSK1358820 200 U injection in the open-label Treatment Phase 2 (Treatment Cycle 2). | 0 | None | 1 | 10 | 5 | 10 | View |
| Treatment Cycle 2: GSK1358820 200 U / GSK1358820 200 U | Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2). | 0 | None | 0 | 6 | 5 | 6 | View |
| Treatment Cycle 3: GSK1358820 200 U / GSK1358820 200 U | Participants received a single (double-blind) dose of GSK1358820 (30 injections of 1.0 mL each) injected into the detrusor muscle of the bladder, using cystoscopy, and under local anesthesia in Treatment Phase 1 (Treatment Cycle 1). Participants who met re-treatment criteria between 12 and 36 weeks after the first treatment received re-treatment with GSK1358820 200 U (open-label) in Treatment Phase 2 (Treatment Cycle 2) and further re-treatment with GSK1358820 200 U in Treatment Phase 2 (Treatment Cycle 3). | 0 | None | 0 | 3 | 3 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 21.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Tooth loss | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Autonomic dysreflexia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Skin abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 21.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 21.1 | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 21.1 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Retinal tear | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 21.1 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 21.1 | View |
| Epididymitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Nasal herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 21.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 21.1 | View |
| Urethral polyp | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 21.1 | View |
| Muscle spasticity | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 21.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 21.1 | View |
| Occult blood | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 21.1 | View |
| Urethral stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 21.1 | View |
| Urinary bladder haemorrhage | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 21.1 | View |
| Thyroiditis subacute | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA Version 21.1 | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 21.1 | View |