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 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
NCT ID:
NCT03979820
Description:
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Frequency Threshold:
5
Time Frame:
Tyramine screening: From Day -11 to time of first administration of BI 1467335, placebo or phenelzine Day 1, up to 11 days. Placebo, 10 mg BI 1467335, 15 mg BI 1467335: From Day 1 to Day 29, up to 28 days. Phenelzine: From Day 1 to Day 8, up to 7 days. Placebo + Tyramine, 10 mg BI 1467335 + Tyramine, 15 mg BI 1467335 + Tyramine: From Day 29 up to End of trial (EoT), up to 23 days. Phenelzine +Tyramine: From Day 8 until EoT, up to 24 days.
Study:
NCT03979820
Study Brief:
A Study in Healthy People to Test How Combining BI 1467335 and Tyramine Affects Blood Pressure
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Tyramine Screening | As part of the screening procedure, participants were challenged (tyramine screening/baseline challenge) from Day -11 up to Day -2 with escalating oral doses of tyramine. Planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, 700 mg given once daily orally with 240 ml of water. In each individual participant, the tyramine dose escalation was stopped when SBP increased ≥30 mmHg in at least 3 consecutive measurements (TYR30). Participants who did not attain the predefined systolic BP target elevation within 4 h after 700 mg tyramine were not to be included in the trial. | 0 | None | 0 | 53 | 39 | 53 | View |
| Placebo | From Day 1 to Day 28 participants received once daily 2 or 3 film-coated tablets of 5 mg of placebo matching BI 1467335 administered once daily (daily dosage: 10 or 15 mg) orally with 240 ml of water. | 0 | None | 0 | 13 | 9 | 13 | View |
| Phenelzine | From Day 1 to Day 7 participants received 1 film-coated tablet of 15 mg of phenelzine sulfate administered twice daily (daily dosage: 30 mg) orally with 240 ml of water. | 0 | None | 0 | 14 | 11 | 14 | View |
| 10 mg BI 1467335 | From Day 1 to Day 28 participants received 2 film-coated tablets of 5 mg of BI 1467335 administered once daily (daily dosage:10 mg) orally with 240 ml of water. | 0 | None | 0 | 16 | 8 | 16 | View |
| 15 mg BI 1467335 | From Day 1 to Day 28 participants received 3 film-coated tablets of 5mg of BI 1467335 administered once daily (daily dosage: 15 mg) orally with 240 ml of water. | 0 | None | 0 | 10 | 7 | 10 | View |
| Placebo + Tyramine | Participants received from Day 29 up to Day 39 concomitant medication of 2 0r 3 film-coated tablets of 5 mg of placebo matching BI 1467335 administered once daily (daily dosage:10 or 15mg) orally with 240 ml of water and escalating doses of tyramine (tyramine steady state challenge) until TYR30 was reached. The planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg given once daily orally with 240 ml of water. Treatment with placebo matching BI 1467335 was to be stopped as soon as the individual subject had attained TYR30 on treatment. | 0 | None | 0 | 9 | 8 | 9 | View |
| Phenelzine + Tyramine | Participants received from Day 8 up to Day 19 concomitant medication of 1 film-coated tablets of 15 mg of phenelzine sulfate (Nardil®) administered twice daily from Day 8 up to Day 18 (daily dosage: 30 mg) and once daily on Day 19 (daily dosage: 15 mg) orally with 240 ml of water and escalating doses of tyramine (tyramine steady state challenge) until TYR30 was reached. The planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg given once daily orally with 240 ml of water. Additionally an intermediate tyramine dose of 150 mg once daily was administered. Treatment with phenelzine sulfate was stopped as soon as the individual subject attained TYR30 on treatment. | 0 | None | 0 | 14 | 14 | 14 | View |
| 15 mg BI 1467335 + Tyramine | Participants received from Day 29 up to Day 39 concomitant medication of 3 film-coated tablets of 5 mg of BI 1467335 administered once daily (daily dosage 15mg) orally with 240 ml of water and escalating doses of tyramine (tyramine steady state challenge) until TYR30 was reached. The planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg given once daily orally with 240 ml of water. Treatment with BI 1467335 was to be stopped as soon as the individual subject had attained TYR30 on treatment. | 0 | None | 0 | 6 | 5 | 6 | View |
| 10 mg BI 1467335 + Tyramine | Participants received from Day 29 up to Day 39 concomitant medication of 2 film-coated tablets of 5mg of BI 1467335 administered once daily (total dosage: 10 mg) orally with 240 ml of water and escalating doses of tyramine (tyramine steady state challenge) until TYR30 was reached. The planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg given once daily orally with 240 ml of water. Treatment with BI 1467335 was stopped as soon as the individual subject attained TYR30 on treatment. | 0 | None | 1 | 15 | 10 | 15 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Troponin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Mood altered | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Fear | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Nervousness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Laziness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Skin irritation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Oropharyngeal discomfort | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Dry throat | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 23.0 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 23.0 | View |
| Peripheral coldness | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 23.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.0 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Epigastric discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Hyperaesthesia teeth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Catheter site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Catheter site related reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Catheter site haematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Medical device site irritation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Medical device site dermatitis | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Catheter site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Medical device site reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Feeling cold | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Feeling hot | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Hunger | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Psychomotor hyperactivity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Visual field defect | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |