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 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
NCT ID:
NCT01505894
Description:
Treated set was used for analysis of adverse events data.
Frequency Threshold:
5
Time Frame:
From first drug administration until the end-of-trial examination, up to 28 days.
Study:
NCT01505894
Study Brief:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| BI 409306 25 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days. | 0 | None | 0 | 9 | 5 | 9 | View |
| BI 409306 25 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 25 milligram film coated tablet orally once daily for 14 days. | 0 | None | 0 | 9 | 6 | 9 | View |
| BI 409306 50 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days. | 0 | None | 0 | 9 | 4 | 9 | View |
| BI 409306 50 Milligram- Young Subjects (BID) | Healthy young subjects administered with BI 409306 50 milligram film coated tablet orally twice daily (BID) from day 2 to 13 , and once daily on days 1 and 14. (Dose group 2). | 0 | None | 0 | 9 | 8 | 9 | View |
| BI 409306 50 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 50 milligram film coated tablet orally once daily for 14 days. | 0 | None | 0 | 8 | 5 | 8 | View |
| BI 409306 100 Milligram- Young Subjects (QD) | Healthy young subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days. | 0 | None | 0 | 9 | 8 | 9 | View |
| BI 409306 100 Milligram- Elderly Subjects (QD) | Healthy elderly subjects administered with BI 409306 100 milligram film coated tablet orally once daily for 14 days. | 0 | None | 0 | 9 | 8 | 9 | View |
| Placebo- Young Subjects | Healthy young subjects administered with placebo (matching BI409306) orally once daily for 14 days or twice daily on Days 2 to 13 with two single doses on the Days 1 and 14 for dose group 2. | 0 | None | 0 | 12 | 6 | 12 | View |
| Placebo-Elderly Subjects Once Daily (QD) | Healthy elderly subjects administered with placebo (matching BI409306) orally once daily (QD) for 14 days. | 0 | None | 0 | 9 | 3 | 9 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Cerumen impaction | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 15.0 | View |
| Abnormal sensation in eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Asthenopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Chromatopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Photopsia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Nervousness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Withdrawal syndrome | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Nasal dryness | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Faeces hard | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |