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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002600-38 | EudraCT Number |
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The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics of BI 3006337 in healthy male subjects following subcutaneous administration of single-rising doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 3006337 0.2 mg | Experimental | Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
|
| BI 3006337 0.5 mg | Experimental | Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
|
| BI 3006337 1 mg | Experimental | Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
|
| BI 3006337 2 mg | Experimental | Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
|
| BI 3006337 4 mg | Experimental | Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3006337 | Drug | BI 3006337 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Drug-related Adverse Events (AEs) After a Single Dose of BI 3006337 | Number of subjects with drug-related adverse events (AEs) after a single dose of BI 3006337 is reported. For drug-related adverse events, medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history. | From 1 day pre-dose till end of trial, up to 40 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity is reported (AUC0-∞). | Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36. |
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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 (Temperature, blood pressure (BP), pulse rate (PR)), 12-lead ECG, and clinical laboratory tests
Age of ≥18 to ≤55 years at screening (SCR)
BMI of ≥20.0 to <32.0 kg/m2 at SCR
A minimum absolute body weight (BW) of 70 kilograms (kg) at SCR
Male subjects who meet any of the following criteria from the administration of trial medication until 30 days after administration of trial medication:
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Life Science Services - Clinical Research | Edegem | 2650 | Belgium | |||
| ICON |
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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/datatransparency
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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 was a single-blind, partially randomized within dose groups, placebo-controlled, single rising dose, parallel (sequential) group study in healthy male participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| FG001 | BI 3006337 0.2 mg | Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| FG002 | BI 3006337 0.5 mg | Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| FG003 | BI 3006337 1 mg | Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| FG004 | BI 3006337 2 mg | Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| FG005 | BI 3006337 4 mg | Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| FG006 | BI 3006337 8 mg | Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| FG007 | BI 3006337 15 mg | Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| FG008 | BI 3006337 30 mg | Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| FG009 | BI 3006337 50 mg | Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| FG010 | BI 3006337 100 mg | Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| FG011 | BI 3006337 150 mg | Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set (TS): The treated set included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| BG001 |
| 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 (AEs) After a Single Dose of BI 3006337 | Number of subjects with drug-related adverse events (AEs) after a single dose of BI 3006337 is reported. For drug-related adverse events, medical judgment was used to determine whether there was a reasonable possibility of a causal relationship between the AE and the given trial treatment, considering all relevant factors, including pattern of reaction, temporal relationship, de-challenge or re-challenge, confounding factors such as concomitant medication, concomitant diseases and relevant history. | Treated set (TS): The treated set included all subjects who were entered and treated with any dose of the trial drug or placebo. | Posted | Count of Participants | Participants | From 1 day pre-dose till end of trial, up to 40 days |
|
From 1 day pre-dose till end of trial, up to 40 days
Adverse events were reported for the treated set (TS). The TS included all subjects who were entered and treated with any dose of BI 3006337 or placebo.
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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 | This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 25.1 | 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 | Nov 24, 2022 | Oct 30, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2023 | Oct 30, 2025 | SAP_001.pdf |
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|
| BI 3006337 8 mg | Experimental | Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
|
| BI 3006337 15 mg | Experimental | Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
|
| BI 3006337 30 mg | Experimental | Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
|
| BI 3006337 50 mg | Experimental | Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
|
| BI 3006337 100 mg | Experimental | Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
|
| BI 3006337 150 mg | Experimental | Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
|
| Placebo | Placebo Comparator | This arm comprises all placebo-treated participants in the trial who were equally distributed across dose groups. Solution for subcutaneous (s.c) injection of placebo was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
|
| Placebo | Drug | Placebo |
|
| Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | Maximum measured concentration of BI 3006337 in serum (Cmax) is reported. | Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36. |
| Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | Time from dosing to the maximum measured concentration of BI 3006337 in serum (tmax) is reported. | Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36. |
| Groningen |
| 9728 NZ |
| Netherlands |
| BI 3006337 0.2 mg |
Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| BG002 | BI 3006337 0.5 mg | Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| BG003 | BI 3006337 1 mg | Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| BG004 | BI 3006337 2 mg | Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| BG005 | BI 3006337 4 mg | Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| BG006 | BI 3006337 8 mg | Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| BG007 | BI 3006337 15 mg | Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| BG008 | BI 3006337 30 mg | Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| BG009 | BI 3006337 50 mg | Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| BG010 | BI 3006337 100 mg | Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| BG011 | BI 3006337 150 mg | Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| BG012 | 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 | BI 3006337 0.2 mg | Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| OG002 | BI 3006337 0.5 mg | Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| OG003 | BI 3006337 1 mg | Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| OG004 | BI 3006337 2 mg | Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| OG005 | BI 3006337 4 mg | Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| OG006 | BI 3006337 8 mg | Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| OG007 | BI 3006337 15 mg | Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| OG008 | BI 3006337 30 mg | Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| OG009 | BI 3006337 50 mg | Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| OG010 | BI 3006337 100 mg | Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
| OG011 | BI 3006337 150 mg | Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. |
|
|
| Secondary | Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) | Area under the concentration-time curve of BI 3006337 in serum over the time interval from 0 extrapolated to infinity is reported (AUC0-∞). | Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint and were 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 contributed only one PK parameter value. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*nanogram per milliliter (h‧ng/mL) | Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36. |
|
|
|
| Secondary | Maximum Measured Concentration of BI 3006337 in Serum (Cmax) | Maximum measured concentration of BI 3006337 in serum (Cmax) is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint and were 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 contributed only one PK parameter value to the statistical assessment. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/ml) | Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36. |
|
|
|
| Secondary | Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum (Tmax) | Time from dosing to the maximum measured concentration of BI 3006337 in serum (tmax) is reported. | Pharmacokinetic (PK) parameter analysis set (PKS): The PKS included all subjects in the TS who provided at least one PK endpoint and were 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 contributed only one PK parameter value to the statistical assessment. | Posted | Median | Full Range | hour (h) | Within 2 hours (h) before drug intake and at 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 58, 72, 96, 120, 168, 240, 336, 504, 672 h after drug intake and at Day 36. |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 9 |
| 19 |
| EG001 | BI 0.2mg | Solution for subcutaneous (s.c) injection containing 0.2 milligrams (mg) of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG002 | BI 0.5mg | Solution for subcutaneous (s.c) injection containing 0.5 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | BI 1mg | Solution for subcutaneous (s.c) injection containing 1 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG004 | BI 2mg | Solution for subcutaneous (s.c) injection containing 2 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG005 | BI 4mg | Solution for subcutaneous (s.c) injection containing 4 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 0 | 5 | 0 | 5 | 3 | 5 |
| EG006 | BI 8mg | Solution for subcutaneous (s.c) injection containing 8 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG007 | BI 15mg | Solution for subcutaneous (s.c) injection containing 15 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG008 | BI 30mg | Solution for subcutaneous (s.c) injection containing 30 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG009 | BI 50mg | Solution for subcutaneous (s.c) injection containing 50 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG010 | BI 100mg | Solution for subcutaneous (s.c) injection containing 100 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG011 | BI 150mg | Solution for subcutaneous (s.c) injection containing 150 mg of BI 3006337 was administered once as a single dose subcutaneously following an overnight fast of at least 10 hours (h) before dosing. | 0 | 9 | 0 | 9 | 4 | 9 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Catheter site induration | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Medical device site irritation | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Medical device site pruritus | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Electrocardiogram QRS complex abnormal | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Pancreatic enzymes increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Pustule | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pseudofolliculitis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | 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.