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 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
NCT ID:
NCT01763333
Description:
None
Frequency Threshold:
5
Time Frame:
From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
Study:
NCT01763333
Study Brief:
To Investigate the Safety, Tolerability, Pharmacokinetics and the Relative Bioavailability of BI 1026706
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 1026706 - Tablet 25 mg (SRD - Part) | Subjects were treated in the morning with one single oral dose of 25 mg film coated tablet with 240 mL of water under fasted condition. | None | None | 0 | 6 | 1 | 6 | View |
| BI 1026706 - Tablet 50 mg (SRD - Part) | Subjects were treated in the morning with one single oral dose of 50 mg (2x25 mg) film coated tablet with 240 mL of water under fasted condition. | None | None | 0 | 6 | 5 | 6 | View |
| BI 1026706 - Tablet 100 mg (SRD - Part) | Subjects were treated in the morning with one single oral dose of 100 mg film coated tablet with 240 mL of water under fasted condition. | None | None | 0 | 6 | 3 | 6 | View |
| BI 1026706 - Tablet 200 mg (SRD - Part) | Subjects were treated in the morning with one single oral dose of 200 mg (2x100 mg) film coated tablet with 240 mL of water under fasted condition. | None | None | 0 | 6 | 2 | 6 | View |
| BI 1026706 - Tablet 400 mg (SRD - Part) | Subjects were treated in the morning with one single oral dose of 400 mg (4x100 mg) film coated tablet with 240 mL of water under fasted condition. | None | None | 0 | 4 | 2 | 4 | View |
| BI 1026706 - Solution 10 mg (SRD - Part) | Subjects were treated in the morning with one single oral dose of 10 mg solution under fasted condition. | None | None | 0 | 6 | 3 | 6 | View |
| BI 1026706 - Solution 100 mg (SRD - Part) | Subjects were treated in the morning with one single oral dose of 100 mg solution under fasted condition. | None | None | 0 | 5 | 2 | 5 | View |
| BI 1026706 - Solution 200 mg (SRD - Part) | Subjects were treated in the morning with one single oral dose of 200 mg solution under fasted condition. | None | None | 0 | 6 | 1 | 6 | View |
| BI 1026706 - Solution 400 mg (SRD - Part) | Subjects were treated in the morning with one single oral dose of 400 mg solution under fasted condition. | None | None | 0 | 5 | 4 | 5 | View |
| Placebo (SRD - Part) | Subjects were treated in the morning with one single oral dose of matching placebo tablet and also matching placebo solution with 240 mL of water under fasted condition. | None | None | 0 | 18 | 8 | 18 | View |
| BI 1026706 - Solution 100 mg Fasted (R2) | Subjects were treated with 100 mg drinking solution (R2) under fasting condition. | None | None | 0 | 11 | 3 | 11 | View |
| BI 1026706 - 100 mg Solution Fed (T2) | Subjects were treated with 100 mg drinking solution (T2) under fed condition. | None | None | 0 | 12 | 3 | 12 | View |
| BI 1026706 - Tablet 100 mg Fasted (R1) | Subjects were treated with 100mg film coated tablet (R1) under fasted condition. | None | None | 0 | 12 | 6 | 12 | View |
| BI 1026706 - Tablet 100 mg Fed (T1) | Subjects were treated with 100mg film coated tablet (T1) under fed condition. | None | None | 0 | 10 | 5 | 10 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Dry throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 16.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Ear discomfort | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 16.0 | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 16.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Application site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 16.0 | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Platelet count increased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Tendon pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 16.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 16.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 16.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 16.0 | View |