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 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
NCT ID:
NCT00689104
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse events starting or worsening in the period from first double-blind study drug intake until 30 days after last double-blind study drug intake.
Study:
NCT00689104
Study Brief:
Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Participants received matching mirabegron placebo tablets and matching tolterodine slow release (SR) placebo capsules orally once a day for 12 weeks. | None | None | 8 | 494 | 49 | 494 | View |
| Mirabegron 50 mg | Participants received mirabegron 50 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks. | None | None | 14 | 493 | 42 | 493 | View |
| Mirabegron 100 mg | Participants received mirabegron 100 mg tablets and matching tolterodine SR placebo capsules orally once a day for 12 weeks. | None | None | 12 | 496 | 41 | 496 | View |
| Tolterodine SR 4 mg | Participants received Tolterodine SR 4 mg capsules and matching mirabegron placebo tablets orally once a day for 12 weeks. | None | None | 11 | 495 | 86 | 495 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v9.1 | View |
| Hepatitis A | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v9.1 | View |
| Postoperative infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v9.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v9.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v9.1 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v9.1 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v9.1 | View |
| Open wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v9.1 | View |
| Gas poisoning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v9.1 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v9.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v9.1 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v9.1 | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v9.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v9.1 | View |
| Atrioventricular block first degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v9.1 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v9.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v9.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v9.1 | View |
| Enterocele | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v9.1 | View |
| Pancreatitis chronic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v9.1 | View |
| Reflux oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v9.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v9.1 | View |
| Calculus urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v9.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v9.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v9.1 | View |
| Cardiovascular evaluation | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v9.1 | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v9.1 | View |
| Catheterisation cardiac | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v9.1 | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v9.1 | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v9.1 | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v9.1 | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v9.1 | View |
| Ruptured cerebral aneurysm | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v9.1 | View |
| Bunion operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v9.1 | View |
| Papilloma excision | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v9.1 | View |
| Polypectomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA v9.1 | View |
| Retinitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v9.1 | View |
| Rotator cuff syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v9.1 | View |
| Sympathetic posterior cervical syndrome | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v9.1 | View |
| Bowen's disease | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v9.1 | View |
| Leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v9.1 | View |
| Pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v9.1 | View |
| Rectocele | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v9.1 | View |
| Vaginal erosion | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v9.1 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v9.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v9.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v9.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v9.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v9.1 | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v9.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v9.1 | View |