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 @ 1:19 PM
Ignite Modification Date:
2025-12-25 @ 12:25 PM
NCT ID:
NCT02169895
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT02169895
Study Brief:
Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| BIA 9-1067 25 mg Group | BIA 9-1067 25 mg Group. with concomitant single oral administration of Prolopa® 100-25 | None | None | 0 | 16 | 10 | 16 | View |
| BIA 9-1067 50 mg Group | BIA 9-1067 50 mg Group. with concomitant single oral administration of Prolopa® 100-25 | None | None | 0 | 16 | 10 | 16 | View |
| BIA 9-1067 100 mg Group | BIA 9-1067 100 mg Group. with concomitant single oral administration of Prolopa® 100-25 | None | None | 0 | 14 | 9 | 14 | View |
| Placebo Group | Placebo Group. with concomitant single oral administration of Prolopa® 100-25 | None | None | 0 | 16 | 6 | 16 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Weakness in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Arrhythmia supraventricular | None | Cardiac disorders | MedDRA (10.0) | View |
| Atrioventricular block first degree | None | Cardiac disorders | MedDRA (10.0) | View |
| Vertigo | None | Ear and labyrinth disorders | MedDRA (10.0) | View |
| Ocular hyperaemia | None | Eye disorders | MedDRA (10.0) | View |
| Abdominal distension | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Constipation | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Dry mouth | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (10.0) | View |
| Fatigue | None | General disorders | MedDRA (10.0) | View |
| Feeling cold | None | General disorders | MedDRA (10.0) | View |
| Venipuncture site swelling | None | General disorders | MedDRA (10.0) | View |
| Vessel puncture site reaction | None | General disorders | MedDRA (10.0) | View |
| Upper respiratory tract infection | None | Infections and infestations | MedDRA (10.0) | View |
| Skin laceration | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Thermal burn | None | Injury, poisoning and procedural complications | MedDRA (10.0) | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA (10.0) | View |
| Blood creatine phosphokinase increased | None | Investigations | MedDRA (10.0) | View |
| Blood glucose decreased | None | Investigations | MedDRA (10.0) | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Muscular weakness | None | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | View |
| Balance disorder | None | Nervous system disorders | MedDRA (10.0) | View |
| Dizziness | None | Nervous system disorders | MedDRA (10.0) | View |
| Dysgeusia | None | Nervous system disorders | MedDRA (10.0) | View |
| Headache | None | Nervous system disorders | MedDRA (10.0) | View |
| Somnolence | None | Nervous system disorders | MedDRA (10.0) | View |
| Tremor | None | Nervous system disorders | MedDRA (10.0) | View |
| Anxiety | None | Psychiatric disorders | MedDRA (10.0) | View |
| Insomnia | None | Psychiatric disorders | MedDRA (10.0) | View |
| Proteinuria | None | Renal and urinary disorders | MedDRA (10.0) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Dry throat | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Nasal dryness | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Pharyngolaryngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | View |
| Flushing | None | Vascular disorders | MedDRA (10.0) | View |