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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
NCT ID:
NCT04201093
Description:
None
Frequency Threshold:
2
Time Frame:
All-cause mortality was reported from enrollment until 4 weeks after the last dose of study drug. Treatment-emergent adverse events and serious adverse events were collected from the first dose of study drug until 4 weeks after the dose of study drug for all Arms. Mean duration on study drug was 27 weeks. Median time on study was 190, 190, 189 days for Placebo, Tavapadon 5 mg, and Tavapadon 15 mg, respectively.
Study:
NCT04201093
Study Brief:
Fixed-Dose Trial in Early Parkinson's Disease (PD)
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 will receive placebo matching to tavapadon tablet QD orally for 27 weeks. | 2 | None | 11 | 175 | 72 | 175 | View |
| Tavapadon 5mg QD | Participants will receive tavapadon tablet titrated up to 5 milligram (mg) once daily (QD) orally for 27 weeks. | 1 | None | 4 | 177 | 125 | 177 | View |
| Tavapadon 15mg QD | Participants will receive tavapadon tablet titrated up to 15 milligram (mg) QD orally for 27 weeks. | 0 | None | 10 | 177 | 125 | 177 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANGINA UNSTABLE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 27.0 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 27.0 | View |
| CORONARY ARTERY STENOSIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 27.0 | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 27.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| PERIPHERAL SWELLING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| COVID-19 PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| TRACHEOBRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| FEMUR FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| HEAD INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| RADIUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| BASAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | View |
| PROSTATE CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | View |
| RENAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| HALLUCINATION, TACTILE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| PROSTATOMEGALY | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 27.0 | View |
| THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 27.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| TINNITUS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 27.0 | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 27.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| SALIVARY HYPERSECRETION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 27.0 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 27.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.0 | View |
| SARS-COV-2 TEST POSITIVE | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 27.0 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 27.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 27.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | View |
| AGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| HYPOAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| PAROSMIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| TREMOR | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.0 | View |
| ABNORMAL DREAMS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| HALLUCINATION, VISUAL | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| SLEEP DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.0 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 27.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 27.0 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 27.0 | View |
| ORTHOSTATIC HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 27.0 | View |