Trial Outcomes & Findings for A Study in Healthy People to Test How Combining BI 1467335 and Tyramine Affects Blood Pressure (NCT NCT03979820)

NCT ID: NCT03979820

Last Updated: 2021-06-04

Results Overview

TSF was defined as ratio of the tyramine dose causing an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30) at baseline and at steady state of BI 1467335, placebo or phenelzine. Geometric Mean is the Geometric Least Squares Mean and is extracted from the ANOVA model that includes all treatments. Standard error is the geometric standard error of the mean (gSE) and is extracted from the ANOVA model that includes all treatments.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

53 participants

Primary outcome timeframe

At baseline (Day -11 up to Day-2) and at steady state (Day 29 up to Day 39 for the "Placebo/Placebo + Tyramine" and "10 mg BI 1467335/10 mg BI 1467335 + Tyramine" arms, Day 8 up to Day 19 for the "Phenelzine/ Phenelzine + Tyramine" arm).

Results posted on

2021-06-04

Participant Flow

This was a a randomised, double-blind, placebo controlled clinical trial in healthy subjects to evaluate the effects of multiple oral doses of BI 1467335 and phenelzine as positive control on blood pressure response to oral tyramine. Trial was ended prematurely due to lockdown of the trial site by the Covid-19 pandemic.

Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct.

Participant milestones

Participant milestones
Measure
Placebo/Placebo + Tyramine
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of placebo matching BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 or 3 film-coated tablets of 5 mg of placebo matching BI 1467335 were administered once daily (daily dosage: 10 or 15 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with placebo matching BI 1467335 was to be stopped as soon as the individual participant had attained TYR30 on treatment.
Phenelzine/Phenelzine + Tyramine
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 8 to Day 19) following multiple doses of phenelzine sulfate (Nardil®). During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. Additionally an intermediate tyramine dose of 150 mg once daily was administered. 1 film-coated tablet of 15 mg of phenelzine sulfate was administered twice daily (daily dosage: 30 mg) from Day 1 to Day 18 and once daily (daily dosage: 15 mg) on Day 19 orally with 240 ml of water. Treatment with phenelzine sulfate was stopped as soon as the individual participant attained TYR30 on treatment.
10 mg BI 1467335/10 mg BI 1467335 + Tyramine
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 film-coated tablets of 5 mg of BI 1467335 were administered once daily (daily dosage: 10 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with BI 1467335 was stopped as soon as the individual participant attained TYR30 on treatment.
15 mg BI 1467335/15 mg BI 1467335 + Tyramine
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of BI 1467335. Participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 3 film-coated tablets of 5 mg of BI 1467335 were administered once daily (daily dosage: 15 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with BI 1467335 was to be stopped as soon as the individual participant attained TYR30 on treatment.
Overall Study
STARTED
13
14
16
10
Overall Study
COMPLETED
7
14
15
0
Overall Study
NOT COMPLETED
6
0
1
10

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo/Placebo + Tyramine
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of placebo matching BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 or 3 film-coated tablets of 5 mg of placebo matching BI 1467335 were administered once daily (daily dosage: 10 or 15 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with placebo matching BI 1467335 was to be stopped as soon as the individual participant had attained TYR30 on treatment.
Phenelzine/Phenelzine + Tyramine
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 8 to Day 19) following multiple doses of phenelzine sulfate (Nardil®). During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. Additionally an intermediate tyramine dose of 150 mg once daily was administered. 1 film-coated tablet of 15 mg of phenelzine sulfate was administered twice daily (daily dosage: 30 mg) from Day 1 to Day 18 and once daily (daily dosage: 15 mg) on Day 19 orally with 240 ml of water. Treatment with phenelzine sulfate was stopped as soon as the individual participant attained TYR30 on treatment.
10 mg BI 1467335/10 mg BI 1467335 + Tyramine
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 film-coated tablets of 5 mg of BI 1467335 were administered once daily (daily dosage: 10 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with BI 1467335 was stopped as soon as the individual participant attained TYR30 on treatment.
15 mg BI 1467335/15 mg BI 1467335 + Tyramine
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of BI 1467335. Participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 3 film-coated tablets of 5 mg of BI 1467335 were administered once daily (daily dosage: 15 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with BI 1467335 was to be stopped as soon as the individual participant attained TYR30 on treatment.
Overall Study
Protocol Violation
1
0
0
0
Overall Study
Withdrawal by Subject
0
0
1
0
Overall Study
Permanent discontinuation of the trial due to Covid-19 pandemic
5
0
0
10

Baseline Characteristics

A Study in Healthy People to Test How Combining BI 1467335 and Tyramine Affects Blood Pressure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo/Placebo + Tyramine
n=13 Participants
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of placebo matching BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 or 3 film-coated tablets of 5 mg of placebo matching BI 1467335 were administered once daily (daily dosage: 10 or 15 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with placebo matching BI 1467335 was to be stopped as soon as the individual participant had attained TYR30 on treatment.
Phenelzine/Phenelzine + Tyramine
n=14 Participants
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 8 to Day 19) following multiple doses of phenelzine sulfate (Nardil®). During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. Additionally an intermediate tyramine dose of 150 mg once daily was administered. 1 film-coated tablet of 15 mg of phenelzine sulfate was administered twice daily (daily dosage: 30 mg) from Day 1 to Day 18 and once daily (daily dosage: 15 mg) on Day 19 orally with 240 ml of water. Treatment with phenelzine sulfate was stopped as soon as the individual participant attained TYR30 on treatment.
10 mg BI 1467335/10 mg BI 1467335 + Tyramine
n=16 Participants
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 film-coated tablets of 5 mg of BI 1467335 were administered once daily (daily dosage: 10 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with BI 1467335 was stopped as soon as the individual participant attained TYR30 on treatment.
15 mg BI 1467335/15 mg BI 1467335 + Tyramine
n=10 Participants
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of BI 1467335. Participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 3 film-coated tablets of 5 mg of BI 1467335 were administered once daily (daily dosage: 15 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with BI 1467335 was to be stopped as soon as the individual participant attained TYR30 on treatment.
Total
n=53 Participants
Total of all reporting groups
Age, Continuous
32.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
31.4 years
STANDARD_DEVIATION 8.6 • n=7 Participants
30.9 years
STANDARD_DEVIATION 6.8 • n=5 Participants
30.4 years
STANDARD_DEVIATION 8.6 • n=4 Participants
31.2 years
STANDARD_DEVIATION 7.8 • n=21 Participants
Sex: Female, Male
Female
5 Participants
n=5 Participants
6 Participants
n=7 Participants
7 Participants
n=5 Participants
3 Participants
n=4 Participants
21 Participants
n=21 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
8 Participants
n=7 Participants
9 Participants
n=5 Participants
7 Participants
n=4 Participants
32 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
3 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
n=5 Participants
14 Participants
n=7 Participants
15 Participants
n=5 Participants
9 Participants
n=4 Participants
50 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
3 Participants
n=21 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
3 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
2 Participants
n=21 Participants
Race (NIH/OMB)
White
12 Participants
n=5 Participants
11 Participants
n=7 Participants
12 Participants
n=5 Participants
7 Participants
n=4 Participants
42 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
3 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Tyramine dose at baseline to reach TYR30
453.846 Milligramm (mg)
STANDARD_DEVIATION 133.012 • n=5 Participants
464.286 Milligramm (mg)
STANDARD_DEVIATION 121.574 • n=7 Participants
456.250 Milligramm (mg)
STANDARD_DEVIATION 126.326 • n=5 Participants
390.000 Milligramm (mg)
STANDARD_DEVIATION 159.513 • n=4 Participants
445.283 Milligramm (mg)
STANDARD_DEVIATION 132.384 • n=21 Participants

PRIMARY outcome

Timeframe: At baseline (Day -11 up to Day-2) and at steady state (Day 29 up to Day 39 for the "Placebo/Placebo + Tyramine" and "10 mg BI 1467335/10 mg BI 1467335 + Tyramine" arms, Day 8 up to Day 19 for the "Phenelzine/ Phenelzine + Tyramine" arm).

Population: Per protocol analysis set (PPS): This analysis set included all participants in the TS who provided at least one endpoint that was defined as primary and was not excluded due to a protocol violation relevant. Descriptive and model-based analyses of the primary endpoint were based on the PPS. Participants of the arms "15 mg BI 1467335/15 mg BI 1467335 + Tyramine" and "Placebo/Placebo + Tyramine" who could not complete the tyramine steady state challenge were excluded from the analysis.

TSF was defined as ratio of the tyramine dose causing an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30) at baseline and at steady state of BI 1467335, placebo or phenelzine. Geometric Mean is the Geometric Least Squares Mean and is extracted from the ANOVA model that includes all treatments. Standard error is the geometric standard error of the mean (gSE) and is extracted from the ANOVA model that includes all treatments.

Outcome measures

Outcome measures
Measure
Placebo/Placebo + Tyramine
n=7 Participants
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of placebo matching BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 or 3 film-coated tablets of 5 mg of placebo matching BI 1467335 were administered once daily (daily dosage: 10 or 15 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with placebo matching BI 1467335 was to be stopped as soon as the individual participant had attained TYR30 on treatment.
Phenelzine/Phenelzine + Tyramine
n=14 Participants
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 8 to Day 19) following multiple doses of phenelzine sulfate (Nardil®). During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. Additionally an intermediate tyramine dose of 150 mg once daily was administered. 1 film-coated tablet of 15 mg of phenelzine sulfate was administered twice daily (daily dosage: 30 mg) from Day 1 to Day 18 and once daily (daily dosage: 15 mg) on Day 19 orally with 240 ml of water. Treatment with phenelzine sulfate was stopped as soon as the individual participant attained TYR30 on treatment.
10 mg BI 1467335/10 mg BI 1467335 + Tyramine
n=14 Participants
Tyramine was administered during the screening process (tyramine screening/baseline challenge, Day -11 to Day -2) and at steady state (tyramine steady state challenge, Day 29 up to Day 39) following multiple doses of BI 1467335. During tyramine baseline challenge and tyramine steady state challenge participants received escalating tyramine doses until tyramine dose caused an increase of systolic blood pressure (SBP) ≥ 30 millimetre of mercury (mmHg) for at least 3 consecutive measurements (TYR30). During the tyramine baseline challenge the planned tyramine doses were 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 milligram (mg) once daily orally with 240 milliliter (ml) of water. During the tyramine steady state challenge the planned tyramine doses were 5, 10, 25, 50, 100, 200, 300, 400, 500, 600, and 700 mg once daily orally with 240 ml of water. 2 film-coated tablets of 5 mg of BI 1467335 were administered once daily (daily dosage: 10 mg) orally with 240 ml of water from Day 1 up to Day 39. Treatment with BI 1467335 was stopped as soon as the individual participant attained TYR30 on treatment.
Tyramine Sensitivity Factor (TSF)
0.98 Ratio of tyramine dose
Standard Error 1.25
5.31 Ratio of tyramine dose
Standard Error 1.17
1.20 Ratio of tyramine dose
Standard Error 1.17

Adverse Events

Tyramine Screening

Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths

Phenelzine

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

10 mg BI 1467335

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

15 mg BI 1467335

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Placebo + Tyramine

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Phenelzine + Tyramine

Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths

10 mg BI 1467335 + Tyramine

Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths

15 mg BI 1467335 + Tyramine

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Tyramine Screening
n=53 participants at risk
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.
Placebo
n=13 participants at risk
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.
Phenelzine
n=14 participants at risk
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.
10 mg BI 1467335
n=16 participants at risk
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.
15 mg BI 1467335
n=10 participants at risk
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.
Placebo + Tyramine
n=9 participants at risk
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.
Phenelzine + Tyramine
n=14 participants at risk
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.
10 mg BI 1467335 + Tyramine
n=15 participants at risk
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.
15 mg BI 1467335 + Tyramine
n=6 participants at risk
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.
Investigations
Troponin increased
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.7%
1/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.

Other adverse events

Other adverse events
Measure
Tyramine Screening
n=53 participants at risk
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.
Placebo
n=13 participants at risk
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.
Phenelzine
n=14 participants at risk
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.
10 mg BI 1467335
n=16 participants at risk
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.
15 mg BI 1467335
n=10 participants at risk
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.
Placebo + Tyramine
n=9 participants at risk
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.
Phenelzine + Tyramine
n=14 participants at risk
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.
10 mg BI 1467335 + Tyramine
n=15 participants at risk
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.
15 mg BI 1467335 + Tyramine
n=6 participants at risk
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.
Gastrointestinal disorders
Nausea
24.5%
13/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
15.4%
2/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.2%
1/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
22.2%
2/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
64.3%
9/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
26.7%
4/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
16.7%
1/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Gastrointestinal disorders
Abdominal pain
7.5%
4/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
15.4%
2/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
12.5%
2/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
14.3%
2/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
13.3%
2/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Gastrointestinal disorders
Diarrhoea
1.9%
1/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
15.4%
2/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.7%
1/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Gastrointestinal disorders
Abdominal pain upper
1.9%
1/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
14.3%
2/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Gastrointestinal disorders
Epigastric discomfort
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
14.3%
2/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Gastrointestinal disorders
Dry mouth
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
12.5%
2/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
10.0%
1/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.7%
1/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
11.1%
1/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Gastrointestinal disorders
Vomiting
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.7%
1/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.7%
1/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Gastrointestinal disorders
Abdominal discomfort
1.9%
1/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Gastrointestinal disorders
Toothache
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Gastrointestinal disorders
Hyperaesthesia teeth
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.7%
1/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Fatigue
5.7%
3/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.7%
1/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
35.7%
5/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
12.5%
2/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
10.0%
1/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
28.6%
4/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Catheter site pain
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
10.0%
1/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
11.1%
1/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
26.7%
4/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
33.3%
2/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Catheter site related reaction
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
15.4%
2/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
14.3%
2/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.2%
1/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
22.2%
2/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
13.3%
2/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Chest discomfort
7.5%
4/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
21.4%
3/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
13.3%
2/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Catheter site haematoma
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.2%
1/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
16.7%
1/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Medical device site irritation
9.4%
5/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
10.0%
1/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.7%
1/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
16.7%
1/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Medical device site dermatitis
13.2%
7/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Catheter site bruise
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.2%
1/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
11.1%
1/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Medical device site reaction
1.9%
1/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
11.1%
1/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.7%
1/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Chest pain
1.9%
1/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
10.0%
1/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.7%
1/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Discomfort
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Feeling cold
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Feeling hot
1.9%
1/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
General disorders
Hunger
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Nervous system disorders
Headache
37.7%
20/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
23.1%
3/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
25.0%
4/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
40.0%
4/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
22.2%
2/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
42.9%
6/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
26.7%
4/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
16.7%
1/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Nervous system disorders
Somnolence
1.9%
1/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
28.6%
4/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
20.0%
2/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Nervous system disorders
Dizziness
5.7%
3/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
14.3%
2/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Nervous system disorders
Paraesthesia
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
11.1%
1/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Nervous system disorders
Presyncope
1.9%
1/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Nervous system disorders
Psychomotor hyperactivity
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Nervous system disorders
Visual field defect
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Cardiac disorders
Palpitations
34.0%
18/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.7%
1/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.2%
1/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
21.4%
3/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
13.3%
2/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders
Back pain
11.3%
6/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.7%
1/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
14.3%
2/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.7%
1/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders
Myalgia
5.7%
3/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.2%
1/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
14.3%
2/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.7%
1/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.7%
1/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders
Neck pain
1.9%
1/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.2%
1/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.7%
1/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Psychiatric disorders
Mood altered
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
15.4%
2/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
12.5%
2/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Psychiatric disorders
Fear
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
11.1%
1/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Psychiatric disorders
Nervousness
1.9%
1/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
11.1%
1/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Psychiatric disorders
Laziness
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.7%
1/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Psychiatric disorders
Depressed mood
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Psychiatric disorders
Restlessness
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Psychiatric disorders
Sleep disorder
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Skin and subcutaneous tissue disorders
Hyperhidrosis
7.5%
4/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
11.1%
1/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
14.3%
2/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Skin and subcutaneous tissue disorders
Skin irritation
1.9%
1/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
10.0%
1/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
1.9%
1/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
15.4%
2/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.2%
1/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
10.0%
1/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Respiratory, thoracic and mediastinal disorders
Dry throat
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.2%
1/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Infections and infestations
Nasopharyngitis
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.7%
1/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.2%
1/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
11.1%
1/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Renal and urinary disorders
Pollakiuria
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
11.1%
1/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Reproductive system and breast disorders
Dysmenorrhoea
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
11.1%
1/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Vascular disorders
Peripheral coldness
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.7%
1/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Eye disorders
Vision blurred
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Injury, poisoning and procedural complications
Contusion
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Injury, poisoning and procedural complications
Muscle strain
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
7.1%
1/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
Investigations
Blood pressure increased
0.00%
0/53 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/13 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/16 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/10 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/9 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/14 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
6.7%
1/15 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.
0.00%
0/6 • 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.
Treated set (TS): This analysis set included all subjects who were randomised and received at least one dose of trial medication.

Additional Information

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  • Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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