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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004351-36 | EudraCT Number |
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The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 706321 in healthy male and female subjects following oral administration of multiple rising doses for 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 mg BI 706321 | Experimental | Subjects were orally administered a single daily dose of 2 x 1 capsule of 1 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). |
|
| 5 mg BI 706321 | Experimental | Subjects were orally administered a single daily dose of 1 capsule of 5 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). |
|
| 8 mg BI 706321 + 75 ug midazolam | Experimental | Subjects were orally administered a single daily dose of 1 capsule of 5 milligrams (mg) and 3 capsules of 1 mg of BI 706321 on Day 1 and from Day 6 to 19. Subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 mL of water after an overnight fast of at least 10 hours (h). |
|
| 10 mg BI 706321+ 75 ug midazolam | Experimental | Subjects were orally administered a single daily dose of 2 capsules of 5 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. Subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 mL of water after an overnight fast of at least 10 hours (h). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 703621 | Drug | BI 703621 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Drug-related Adverse Events | Number of subjects with drug-related adverse events is presented. | From first administration of study drug until 8 days after the last dosing, up to 27 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | Area under the concentration-time curve of BI 706321 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) is presented with a dosing interval τ of 24 hours. Pharmacokinetics parameters were determined after the last dose. | From 432.5 hours (h) and 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h, 456h after dosing on Day 1. |
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Inclusion Criteria:
Exclusion Criteria:
Female subjects will not be allowed to participate, if any of the following apply:
Male subjects will not be allowed to participate, if any of the following apply:
- Male subjects with women of childbearing potential (WOCBP) partner who are unwilling to use male contraception (condom or sexual abstinence) from time point of administration of trial medication until 30 days thereafter. Sperm donation is not allowed from the time point of drug administration until 30 days thereafter.
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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: http://trials.boehringer-ingelheim.com/
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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 (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
This is a double-blind, randomised, placebo-controlled, parallel group design trial in order to investigate safety, tolerability, and pharmacokinetics of BI 706321 in healthy male and female subjects following oral administration of multiple rising doses for 14 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Subjects were orally administered a single daily dose of matching placebo to BI 706321 capsules on Day 1 and from Day 6 to 19. Three out of the seven subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). |
| FG001 | 2 mg BI 706321 | Subjects were orally administered a single daily dose of 2 x 1 capsule of 1 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). |
| FG002 | 5 mg BI 706321 | Subjects were orally administered a single daily dose of 1 capsule of 5 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). |
| FG003 | 8 mg BI 706321 + 75 ug Midazolam | Subjects were orally administered a single daily dose of 1 capsule of 5 milligrams (mg) and 3 capsules of 1 mg of BI 706321 on Day 1 and from Day 6 to 19. Subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 mL of water after an overnight fast of at least 10 hours (h). |
| FG004 | 10 mg BI 706321+ 75 ug Midazolam | Subjects were orally administered a single daily dose of 2 capsules of 5 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. Subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 mL of water after an overnight fast of at least 10 hours (h). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. The TS was used for safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Subjects were orally administered a single daily dose of matching placebo to BI 706321 capsules on Day 1 and from Day 6 to 19. Three out of the seven subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). |
| 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 | Number of Subjects With Drug-related Adverse Events | Number of subjects with drug-related adverse events is presented. | Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. The TS was used for safety analyses. | Posted | Count of Participants | Participants | From first administration of study drug until 8 days after the last dosing, up to 27 days. |
|
For on-treatment adverse events (AE) and all-cause mortality: From first administration of study drug until 8 days after the last dosing, up to 27 days.
Treated set (TS): The TS included all subjects who were randomised and treated with at least 1 dose of trial drug. The treatment assignment was determined based on the first treatment the subjects received. The TS was used for safety analyses.
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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 | Subjects were orally administered a single daily dose of matching placebo to BI 706321 capsules on Day 1 and from Day 6 to 19. Three out of the seven subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | 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 | Jun 2, 2020 | Nov 4, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2021 | Nov 4, 2021 | 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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|
| Placebo | Placebo Comparator | Subjects were orally administered a single daily dose of matching placebo to BI 706321 capsules on Day 1 and from Day 6 to 19. Three out of the seven subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). |
|
| Placebo | Drug | Placebo |
|
| Midazolam | Drug | Midazolam |
|
| Maximum Measured Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | Maximum measured concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) is presented with a dosing interval τ of 24 hours. Pharmacokinetics parameters were determined after the last dose. | From 432.5 hours (h) and 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h and 456h after dosing on Day 1. |
| Minimum Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss) | Minimum concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmin,ss) is presented with a dosing interval τ of 24 hours. Pharmacokinetics parameters were determined after the last dose. | From 432.5 hours (h) and 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h and 456h after dosing on Day 1. |
| Accumulation Ratio Based on Cmax,ss (RA,Cmax) | Accumulation ratio (RA) based on maximum measured concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmax,ss), (RA,Cmax) is presented. RA,cmax = Cmax,ss [nmol/L]/ Cmax,1 [nmol/l], and the unit of measure is hence unitless. | Within 3 hours (h) prior to drug administration on Day 1 and 0.5h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 432.5h, 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h and 456h after dosing on Day 1. |
| Accumulation Ratio Based on AUC0-τ (RA,AUC) | Accumulation ratio (RA) based on area under the concentration-time curve of BI 706321 in plasma after repeated doses over the time interval from τ (AUC0-τ), (RA,AUC) is presented with a dosing interval τ of 24 hours. RA, AUC= AUC tau, ss [h*nmol/L]/ AUC tau,1 [h*nmol/L]; hence the unit of measure is unitless. | Within 3 hours (h) prior to drug administration on Day 1 and 0.5h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 432.5h, 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h and 456h after dosing on Day 1. |
| BG001 | 2 mg BI 706321 | Subjects were orally administered a single daily dose of 2 x 1 capsule of 1 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). |
| BG002 | 5 mg BI 706321 | Subjects were orally administered a single daily dose of 1 capsule of 5 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). |
| BG003 | 8 mg BI 706321 + 75 ug Midazolam | Subjects were orally administered a single daily dose of 1 capsule of 5 milligrams (mg) and 3 capsules of 1 mg of BI 706321 on Day 1 and from Day 6 to 19. Subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 mL of water after an overnight fast of at least 10 hours (h). |
| BG004 | 10 mg BI 706321+ 75 ug Midazolam | Subjects were orally administered a single daily dose of 2 capsules of 5 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. Subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 mL of water after an overnight fast of at least 10 hours (h). |
| BG005 | 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 | 2 mg BI 706321 | Subjects were orally administered a single daily dose of 2 x 1 capsule of 1 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). |
| OG002 | 5 mg BI 706321 | Subjects were orally administered a single daily dose of 1 capsule of 5 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). |
| OG003 | 8 mg BI 706321 + 75 ug Midazolam | Subjects were orally administered a single daily dose of 1 capsule of 5 milligrams (mg) and 3 capsules of 1 mg of BI 706321 on Day 1 and from Day 6 to 19. Subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 mL of water after an overnight fast of at least 10 hours (h). |
| OG004 | 10 mg BI 706321+ 75 ug Midazolam | Subjects were orally administered a single daily dose of 2 capsules of 5 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. Subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 mL of water after an overnight fast of at least 10 hours (h). |
|
|
| Secondary | Area Under the Concentration-time Curve of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss) | Area under the concentration-time curve of BI 706321 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss) is presented with a dosing interval τ of 24 hours. Pharmacokinetics parameters were determined after the last dose. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour(h)*nanomole(nmol)/Litre (L) | From 432.5 hours (h) and 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h, 456h after dosing on Day 1. |
|
|
|
| Secondary | Maximum Measured Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss) | Maximum measured concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmax,ss) is presented with a dosing interval τ of 24 hours. Pharmacokinetics parameters were determined after the last dose. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole(nmol)/Litre(L) | From 432.5 hours (h) and 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h and 456h after dosing on Day 1. |
|
|
|
| Secondary | Minimum Concentration of BI 706321 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmin,ss) | Minimum concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmin,ss) is presented with a dosing interval τ of 24 hours. Pharmacokinetics parameters were determined after the last dose. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole(nmol)/Litre(L) | From 432.5 hours (h) and 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h and 456h after dosing on Day 1. |
|
|
|
| Secondary | Accumulation Ratio Based on Cmax,ss (RA,Cmax) | Accumulation ratio (RA) based on maximum measured concentration of BI 706321 in plasma at steady state over a uniform dosing interval τ (Cmax,ss), (RA,Cmax) is presented. RA,cmax = Cmax,ss [nmol/L]/ Cmax,1 [nmol/l], and the unit of measure is hence unitless. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | Unitless | Within 3 hours (h) prior to drug administration on Day 1 and 0.5h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 432.5h, 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h and 456h after dosing on Day 1. |
|
|
|
| Secondary | Accumulation Ratio Based on AUC0-τ (RA,AUC) | Accumulation ratio (RA) based on area under the concentration-time curve of BI 706321 in plasma after repeated doses over the time interval from τ (AUC0-τ), (RA,AUC) is presented with a dosing interval τ of 24 hours. RA, AUC= AUC tau, ss [h*nmol/L]/ AUC tau,1 [h*nmol/L]; hence the unit of measure is unitless. | Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least 1 PK endpoint that was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | Untiless | Within 3 hours (h) prior to drug administration on Day 1 and 0.5h, 1h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 432.5h, 433h, 434h, 435h, 436h, 437h, 438h, 440h, 442h, 444h, 446h and 456h after dosing on Day 1. |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | 2 mg BI 706321 | Subjects were orally administered a single daily dose of 2 x 1 capsule of 1 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). | 0 | 8 | 0 | 8 | 3 | 8 |
| EG002 | 5 mg BI 706321 | Subjects were orally administered a single daily dose of 1 capsule of 5 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. The trial medication was administered with about 240 millilitres (mL) of water after an overnight fast of at least 10 hours (h). | 0 | 8 | 0 | 8 | 5 | 8 |
| EG003 | 8 mg BI 706321 + 75 ug Midazolam | Subjects were orally administered a single daily dose of 1 capsule of 5 milligrams (mg) and 3 capsules of 1 mg of BI 706321 on Day 1 and from Day 6 to 19. Subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 mL of water after an overnight fast of at least 10 hours (h). | 0 | 8 | 0 | 8 | 6 | 8 |
| EG004 | 10 mg BI 706321+ 75 ug Midazolam | Subjects were orally administered a single daily dose of 2 capsules of 5 milligrams (mg) of BI 706321 on Day 1 and from Day 6 to 19. Subjects were also orally administered a single daily dose of 1.5 millilitres (mL) (75 micrograms) of Midazolam solution on Day -1 and Day 19. The trial medication was administered with about 240 mL of water after an overnight fast of at least 10 hours (h). | 0 | 8 | 0 | 8 | 5 | 8 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cheilosis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Vascular procedure complication | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| External ear pain | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 23.1 | 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 |