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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004923-18 | EudraCT Number |
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The primary objectives of this trial are to investigate safety and tolerability of BI 1595043 in healthy male subjects following administration of multiple rising doses over 14 days.
Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1595043 after single and multiple dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo / Placebo + Midazolam | Placebo Comparator | Placebo matching BI 1595043. Patients included in the placebo arm corresponding to dose group 3, also received Midazolam. |
|
| 15 mg BI 1595043 | Experimental | 15 milligram (mg) BI 1595043. Dose group 1. |
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| 30 mg BI 1595043 | Experimental | 30 mg BI 1595043. Dose group 2. |
|
| 60 mg BI 1595043 + Midazolam | Experimental | 60 mg BI 1595043 + Midazolam. Dose group 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1595043 | Drug | BI 1595043 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Drug-related Adverse Events (AEs) | Percentage of participants with drug-related adverse events (AEs). The causal relationship of AEs to the investigational product was judged by the investigator. The investigator was asked to record a 'yes' if there was, in his/her judgement, a reasonable causal relationship between the investigational product administered and the AE or a 'no' if there was, in his/her judgement, no reasonable causal relationship between the investigational product administered and the AE. | From first drug administration until end of trial examination, up to 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 1595043 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (AUC0-Ï„,ss) | Area under the concentration-time curve of BI 1595043 in plasma at steady state over a uniform dosing interval Ï„ (AUC0-Ï„,ss) after the last dose of BI 1595043. | 0.25 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 and 144 hours after the last dose of BI 1595043. |
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Inclusion Criteria:
Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 50 years (inclusive)
BMI of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Life Science Services - Clinical Research | Edegem | 2650 | Belgium |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
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All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they strictly met all inclusion and none of the exclusion criteria. All subjects were informed that they were free to withdraw their consent at any time during the trial without penalty or prejudice. Subjects were recruited to a dose group according to their temporal availability and randomised within each dose group in a 4:1 ratio (trial drug to placebo).
A double-blind, randomised, placebo-controlled, parallel group trial to investigate the safety and tolerability of BI 1595043 in healthy male subjects after oral administration of multiple rising doses of 14 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo / Placebo + Midazolam | Film-coated tablets of Placebo, matching to 5 milligram (mg) and 25 mg BI 1595043,were administered orally once daily with 240 milliliter (mL) of water to the corresponding dose group. Patients included in the placebo arm corresponding to dose group 3, also received a single oral dose of 75 µg (5 mg/5 mL diluted to 50 µg/mL·1.5 mL) solution for injection of midazolam on Day - 1, Day 1 and Day 18. |
| FG001 | 15 mg BI 1595043 qd | 3 film-coated tablets of 5 milligram (mg) (total dose: 15 mg) BI 1595043 were administered orally once daily (qd), with 240 mL of water after an overnight fast of at least 10 hours (h) on Day 1, followed by a washout of 4 days and from Day 5 to Day 18. Dose group 1. |
| FG002 | 30 mg BI 1595043 qd | 1 film-coated tablet of 5 mg and 1 film-coated tablet of 25 mg (total dose: 30 mg) of BI 1595043 were administered orally once daily (qd), with 240 mL of water after an overnight fast of at least 10 hours (h) on Day 1, followed by a washout of 4 days and from Day 5 to Day 18. Dose group 2. |
| FG003 | 60 mg BI 1595043 qd + Midazolam | 2 film-coated tablets of 5 mg and 2 film-coated tablets of 25 mg (total dose: 60 mg) of BI 1595043 were administered orally once daily (qd), with 240 mL of water after an overnight fast of at least 10 hours (h) on Day 1, followed by a washout of 4 days and from Day 5 to Day 18. On Day - 1, Day 1 and Day 18, 75 µg (5 mg/5 mL diluted to 50 µg/mL·1.5 mL) solution for injection of midazolam was administered as single oral dose. Dose group 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated Set (TS): The TS included all subjects who were randomised and treated with at least one dose of trial drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo / Placebo + Midazolam | Film-coated tablets of Placebo, matching to 5 milligram (mg) and 25 mg BI 1595043,were administered orally once daily with 240 milliliter (mL) of water to the corresponding dose group. Patients included in the placebo arm corresponding to dose group 3, also received a single oral dose of 75 µg (5 mg/5 mL diluted to 50 µg/mL·1.5 mL) solution for injection of midazolam on Day - 1, Day 1 and Day 18. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Drug-related Adverse Events (AEs) | Percentage of participants with drug-related adverse events (AEs). The causal relationship of AEs to the investigational product was judged by the investigator. The investigator was asked to record a 'yes' if there was, in his/her judgement, a reasonable causal relationship between the investigational product administered and the AE or a 'no' if there was, in his/her judgement, no reasonable causal relationship between the investigational product administered and the AE. | Treated Set (TS): The TS included all subjects who were randomised and treated with at least one dose of trial drug. | Posted | Number | Percentage of participants | From first drug administration until end of trial examination, up to 30 days. |
|
From first drug administration until end of trial examination, up to 30 days.
Treated Set (TS): The TS included all subjects who were randomised and treated with at least one dose of trial drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo / Placebo + Midazolam | Film-coated tablets of Placebo, matching to 5 milligram (mg) and 25 mg BI 1595043,were administered orally once daily with 240 milliliter (mL) of water to the corresponding dose group. Patients included in the placebo arm corresponding to dose group 3, also received a single oral dose of 75 µg (5 mg/5 mL diluted to 50 µg/mL·1.5 mL) solution for injection of midazolam on Day - 1, Day 1 and Day 18. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA 24.1 | Systematic Assessment |
The sponsor decided to terminate the development of BI 1595043 in all indications, the trial prematurely ended according to a protocol-defined option. Trial was completed as described in protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim, Call Centre | 018002430127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 23, 2021 | Jun 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2022 | Jun 29, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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As this is a Multiple Rising Dose (MRD) trial, blinded individuals will be aware of the current dose level.
All individuals are unblinded regarding the midazolam administration.
| Placebo | Drug | Placebo |
|
| Midazolam | Drug | Midazolam |
|
| Maximum Measured Concentration of BI 1595043 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (Cmax,ss) | Maximum measured concentration of BI 1595043 in plasma at steady state over a uniform dosing interval Ï„ (Cmax,ss) after the last dose of BI 1595043. | 0.25 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 and 144 hours after the last dose of BI 1595043. |
| Minimum Measured Concentration of BI 1595043 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (Cmin,ss) | Minimum measured concentration of BI 1595043 in plasma at steady state over a uniform dosing interval Ï„ (Cmin,ss) after the last dose of BI 1595043. | 0.25 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 and 144 hours after the last dose of BI 1595043. |
| Accumulation Ratio Based on Maximum Measured Concentration of BI 1595043 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (Cmax,ss) (RA, Cmax) | Accumulation ratio based on maximum measured concentration of BI 1595043 in plasma at steady state over a uniform dosing interval Ï„ (Cmax,ss) (RA, Cmax), after the last dose. RA,Cmax = Cmax after last dose / Cmax after first dose. | 0.25 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 and 144 hours after the last dose of BI 1595043. |
| Accumulation Ratio Based on Area Under the Concentration-time Curve of BI 1595043 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (AUC0-Ï„,ss) (RA, AUC) | Accumulation ratio based on area under the concentration-time curve of BI 1595043 in plasma at steady state over a uniform dosing interval Ï„ (AUC0-Ï„,ss) (RA, AUC). RA,AUC = AUC0-\tau after last dose / AUC0-\tau after first dose. | 0.25 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 and 144 hours after the last dose of BI 1595043. |
| BG001 | 15 mg BI 1595043 qd | 3 film-coated tablets of 5 milligram (mg) (total dose: 15 mg) BI 1595043 were administered orally once daily (qd), with 240 mL of water after an overnight fast of at least 10 hours (h) on Day 1, followed by a washout of 4 days and from Day 5 to Day 18. Dose group 1. |
| BG002 | 30 mg BI 1595043 qd | 1 film-coated tablet of 5 mg and 1 film-coated tablet of 25 mg (total dose: 30 mg) of BI 1595043 were administered orally once daily (qd), with 240 mL of water after an overnight fast of at least 10 hours (h) on Day 1, followed by a washout of 4 days and from Day 5 to Day 18. Dose group 2. |
| BG003 | 60 mg BI 1595043 qd + Midazolam | 2 film-coated tablets of 5 mg and 2 film-coated tablets of 25 mg (total dose: 60 mg) of BI 1595043 were administered orally once daily (qd), with 240 mL of water after an overnight fast of at least 10 hours (h) on Day 1, followed by a washout of 4 days and from Day 5 to Day 18. On Day - 1, Day 1 and Day 18, 75 µg (5 mg/5 mL diluted to 50 µg/mL·1.5 mL) solution for injection of midazolam was administered as single oral dose. Dose group 3. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | 15 mg BI 1595043 qd | 3 film-coated tablets of 5 milligram (mg) (total dose: 15 mg) BI 1595043 were administered orally once daily (qd), with 240 mL of water after an overnight fast of at least 10 hours (h) on Day 1, followed by a washout of 4 days and from Day 5 to Day 18. Dose group 1. |
| OG002 | 30 mg BI 1595043 qd | 1 film-coated tablet of 5 mg and 1 film-coated tablet of 25 mg (total dose: 30 mg) of BI 1595043 were administered orally once daily (qd), with 240 mL of water after an overnight fast of at least 10 hours (h) on Day 1, followed by a washout of 4 days and from Day 5 to Day 18. Dose group 2. |
| OG003 | 60 mg BI 1595043 qd + Midazolam | 2 film-coated tablets of 5 mg and 2 film-coated tablets of 25 mg (total dose: 60 mg) of BI 1595043 were administered orally once daily (qd), with 240 mL of water after an overnight fast of at least 10 hours (h) on Day 1, followed by a washout of 4 days and from Day 5 to Day 18. On Day - 1, Day 1 and Day 18, 75 µg (5 mg/5 mL diluted to 50 µg/mL·1.5 mL) solution for injection of midazolam was administered as single oral dose. Dose group 3. |
|
|
| Secondary | Area Under the Concentration-time Curve of BI 1595043 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (AUC0-Ï„,ss) | Area under the concentration-time curve of BI 1595043 in plasma at steady state over a uniform dosing interval Ï„ (AUC0-Ï„,ss) after the last dose of BI 1595043. | Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Only participants with non-missing values were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours*nanomol per Liter | 0.25 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 and 144 hours after the last dose of BI 1595043. |
|
|
|
| Secondary | Maximum Measured Concentration of BI 1595043 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (Cmax,ss) | Maximum measured concentration of BI 1595043 in plasma at steady state over a uniform dosing interval Ï„ (Cmax,ss) after the last dose of BI 1595043. | Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Only participants with non-missing values were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomol per Liter | 0.25 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 and 144 hours after the last dose of BI 1595043. |
|
|
|
| Secondary | Minimum Measured Concentration of BI 1595043 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (Cmin,ss) | Minimum measured concentration of BI 1595043 in plasma at steady state over a uniform dosing interval Ï„ (Cmin,ss) after the last dose of BI 1595043. | Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Only participants with non-missing values were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanomole per Liter | 0.25 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 and 144 hours after the last dose of BI 1595043. |
|
|
|
| Secondary | Accumulation Ratio Based on Maximum Measured Concentration of BI 1595043 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (Cmax,ss) (RA, Cmax) | Accumulation ratio based on maximum measured concentration of BI 1595043 in plasma at steady state over a uniform dosing interval Ï„ (Cmax,ss) (RA, Cmax), after the last dose. RA,Cmax = Cmax after last dose / Cmax after first dose. | Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. Only participants with non-missing values were included. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | 0.25 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 and 144 hours after the last dose of BI 1595043. |
|
|
|
| Secondary | Accumulation Ratio Based on Area Under the Concentration-time Curve of BI 1595043 in Plasma at Steady State Over a Uniform Dosing Interval Ï„ (AUC0-Ï„,ss) (RA, AUC) | Accumulation ratio based on area under the concentration-time curve of BI 1595043 in plasma at steady state over a uniform dosing interval Ï„ (AUC0-Ï„,ss) (RA, AUC). RA,AUC = AUC0-\tau after last dose / AUC0-\tau after first dose. | Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. Thus, a subject was included in the PKS, even if he/she contributed only one PK parameter value for one period to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio | 0.25 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 and 144 hours after the last dose of BI 1595043. |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | 15 mg BI 1595043 qd | 3 film-coated tablets of 5 milligram (mg) (total dose: 15 mg) BI 1595043 were administered orally once daily (qd), with 240 mL of water after an overnight fast of at least 10 hours (h) on Day 1, followed by a washout of 4 days and from Day 5 to Day 18. Dose group 1. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG002 | 30 mg BI 1595043 qd | 1 film-coated tablet of 5 mg and 1 film-coated tablet of 25 mg (total dose: 30 mg) of BI 1595043 were administered orally once daily (qd), with 240 mL of water after an overnight fast of at least 10 hours (h) on Day 1, followed by a washout of 4 days and from Day 5 to Day 18. Dose group 2. | 0 | 8 | 0 | 8 | 4 | 8 |
| EG003 | 60 mg BI 1595043 qd + Midazolam | 2 film-coated tablets of 5 mg and 2 film-coated tablets of 25 mg (total dose: 60 mg) of BI 1595043 were administered orally once daily (qd), with 240 mL of water after an overnight fast of at least 10 hours (h) on Day 1, followed by a washout of 4 days and from Day 5 to Day 18. On Day - 1, Day 1 and Day 18, 75 µg (5 mg/5 mL diluted to 50 µg/mL·1.5 mL) solution for injection of midazolam was administered as single oral dose. Dose group 3. | 0 | 8 | 0 | 8 | 5 | 8 |
| Blepharitis | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Lenticular opacities | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
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.
| D006571 | Heterocyclic Compounds |