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 @ 2:52 PM
Ignite Modification Date:
2025-12-25 @ 1:18 PM
NCT ID:
NCT03754959
Description:
Treated set (TS): all subjects who received at least one dose of study drug.
Frequency Threshold:
5
Time Frame:
Midazolam AE collection: Up to 1 day BI 1358894 or Placebo + Midazolam AE collection: Up to 1 day BI 1358894 AE collection: Up to 13 days All-cause mortality: Up to 17 days
Study:
NCT03754959
Study Brief:
This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 1358894 Affects the Way the Body Breaks Down Midazolam
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Midazolam | Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water after a standard continental breakfast on Day -1 before administration of BI 1358894/ Placebo | 0 | None | 0 | 50 | 2 | 50 | View |
| Placebo + Midazolam | Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14. Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast. On Day 1 and 14 placebo matching to BI 1358894 was administered immediately prior to midazolam. | 0 | None | 0 | 10 | 1 | 10 | View |
| BI 1358894 10 mg + Midazolam | Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast. Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast. On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam. | 0 | None | 0 | 8 | 4 | 8 | View |
| BI 1358894 25 mg + Midazolam | Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast. Oral administration of midazolam as solution for injection (5 mg/5 mL diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast. On Day 1 and 14 BI 1358894was administered immediately prior to midazolam. | 0 | None | 0 | 8 | 4 | 8 | View |
| BI 1358894 50 mg + Midazolam | Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast. Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast. On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam. | 0 | None | 0 | 8 | 3 | 8 | View |
| BI 1358894 100 mg + Midazolam | Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast. Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast. On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam. | 0 | None | 0 | 8 | 4 | 8 | View |
| BI 1358894 200 mg + Midazolam | Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast. Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast. On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam. | 0 | None | 0 | 8 | 5 | 8 | View |
| Placebo Matching BI 1358894 Dose Group | Oral administration of placebo matching to BI 1358894 film-coated tablet with 240 milliliter (mL) of water after a standard continental breakfast once per day from day 1 to day 14 Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast. On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam. | 0 | None | 0 | 10 | 7 | 10 | View |
| BI 1358894 10 Milligram (mg) Dose Group | Oral administration of 10 milligram (mg) BI 1358894 film-coated tablet (2\*5 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast. Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast. On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam. | 0 | None | 0 | 8 | 3 | 8 | View |
| BI 1358894 25 Milligram (mg) Dose Group | Oral administration of 25 milligram (mg) BI 1358894 film-coated tablet (1\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after a standard continental breakfast. Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast. On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam. | 0 | None | 0 | 8 | 6 | 8 | View |
| BI 1358894 50 Milligram (mg) Dose Group | Oral administration of 50 milligram (mg) BI 1358894 film-coated tablet (2\*25 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast. Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast. On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam. | 0 | None | 0 | 8 | 1 | 8 | View |
| BI 1358894 100 Milligram (mg) Dose Group | Oral administration of 100 milligram (mg) BI 1358894 film-coated tablet (1\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast. Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast. On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam. | 0 | None | 0 | 8 | 4 | 8 | View |
| BI 1358894 200 Milligram (mg) Dose Group | Oral administration of 200 milligram (mg) BI 1358894 film-coated tablet (2\*100 mg tablet) once daily for 14 days with 240 milliliter (mL) water after standard continental breakfast. Oral administration of midazolam as solution for injection (5 mg/5 mL) diluted to 50 microgram (μg)/mL\*1.5 mL (75 μg) with 240 milliliter (mL) water as three single doses on days -1, 1 and 14, after a standard continental breakfast. On Day 1 and 14 BI 1358894 was administered immediately prior to midazolam. | 0 | None | 0 | 8 | 5 | 8 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Orthostatic intolerance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Disturbance in attention | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Head discomfort | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Muscle contractions involuntary | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 22.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 22.0 | View |
| Ocular discomfort | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 22.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 22.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 22.0 | View |
| Procedural dizziness | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Skin injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 22.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | View |
| Dermatitis acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 22.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 22.0 | View |
| Thrombophlebitis superficial | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 22.0 | View |