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 @ 5:13 PM
Ignite Modification Date:
2025-12-25 @ 2:51 PM
NCT ID:
NCT02635750
Description:
The treated set (TS) included all subjects who were documented to have received at least 1 dose of trial drug.
Frequency Threshold:
5
Time Frame:
From first drug intake until end of the residual effect period (REP), which was defined as 24 hours after last intake of BI 409306 or 14 days after last donepezil (DON) administration. In case of combined treatment period started from first combined drug intake until last combined drug intake plus 14 days (REP of DON). Up to 1 day for 'Part 1: 25 mg BI'; up to 14 days for 'Part 1: 25mg BI+ 10mg DON', 'Part 2: 5mg DON' and 'Part 2: 5mg DON+ 100mg BI' and up to 21 days for 'Part 1: 5mg/10mg DON'.
Study:
NCT02635750
Study Brief:
Investigation of Pharmacokinetic Drug-drug Interaction of BI 409306 and Donepezil in Healthy Male and Female Subjects
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 1: 25 mg BI 409306 | One film-coated tablet of 25 milligram (mg) BI 409306 was administered as single oral dose with 240 milliliter (mL) of water after a standardized dinner (reference treatment 1 (R1)). | None | None | 0 | 18 | 5 | 18 | View |
| Part 1: 5 mg Donepezil /10 mg Donepezil | Period 2: On day 1 to 7, subjects received one film-coated tablet of 5 mg donepezil administered orally once daily, followed by 2 film-coated tablets of 5 mg (total: 10 mg) donepezil once daily on day 8 to 21. | None | None | 0 | 18 | 15 | 18 | View |
| Part 1: 25 mg BI 409306 25mg + 10 mg Donepezil | Period 3: One film-coated tablet of 25 mg BI 409306 was administered as single oral dose together with 2 film-coated tablets of 5 mg (total: 10 mg) donepezil with 240 mL of water after a standardized dinner (test treatment 1 (T1)). | None | None | 0 | 17 | 5 | 17 | View |
| Part 2: 5mg Donepezil + 100 mg BI 409306 | One film-coated tablet of 5 mg donepezil together with 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 (test treatment 2 (T2)) were administered orally with 240 ml of water in the morning in fasted state on day 1. From day 2 to day 7, subjects were administered 4 film-coated tablets of 25 mg (total: 100 mg) BI 409306 orally once daily. | None | None | 0 | 14 | 12 | 14 | View |
| Part 2: 5 mg Donepezil | One film-coated tablet of 5 mg donepezil (reference treatment 2 (R2)) was administered as single oral dose with 240 mL of water in the morning in fasted state. | None | None | 0 | 14 | 4 | 14 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 19.0 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 19.0 | View |
| Blepharospasm | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.0 | View |
| Chromatopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.0 | View |
| Photopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.0 | View |
| Visual brightness | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.0 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 19.0 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Defaecation urgency | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Faeces hard | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Gastrointestinal motility disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Salivary hypersecretion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Vessel puncture site thrombosis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.0 | View |
| Herpes simplex | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.0 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.0 | View |
| Occult blood positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 19.0 | View |
| Increased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 19.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Head discomfort | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.0 | View |
| Agitation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.0 | View |
| Ovarian cyst ruptured | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 19.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 19.0 | View |
| Hot flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 19.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | View |