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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004153-22 | EudraCT Number | ||
| 310788 | Other Identifier | Company internal |
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In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has already been approved for application in adults, will be investigated in children and adolescents. MRI is a modern and safe examination method without delivering radiation burden using magnetic fields to produce cross-sectional images of the human body. A special computer program then puts these images together and creates a two or three-dimensional image of the inner organs thus facilitating the detection and evaluation of pathological changes. In contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the examination which results in a stronger contrast in the examined area. Therefore, pathological changes can be more easily detected and evaluated compared to non-enhanced MRI. The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine. Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e. in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney disease. Gadavist was examined in more than 2,900 adults within the framework of clinical studies during development and has been used after its marketing authorization in meanwhile more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only conducted with adults so far. Diseases requiring MRI examinations, however, often occur in children, too. Therefore, many contrast agents are already used on a regular basis in MRI examinations of children, some of these contrast agents being authorized already. Within the framework of this study the pharmacokinetic characteristics of Gadavist in children or adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in the body. In addition, safety and tolerability will be evaluated in order to demonstrate that Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents. Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body weight also for this population group.
Please note that the present study is allocated two study phases, i.e. phase I and phase III.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - age 2 to 6 years | Experimental | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
|
| Gadobutrol (Gadavist, BAY86-4875) - age 7 to 11 years | Experimental | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
|
| Gadobutrol (Gadavist, BAY86-4875) - age 12 to 17 years | Experimental | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
|
| Gadobutrol (Gadavist, BAY86-4875) - age 2 to 17 years | Experimental | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadobutrol (Gadavist, Gadovist, BAY86-4875) | Drug | In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Clearance Estimates of Gadobutrol by Age Group | Total body clearance of Gadobutrol in plasma in L/h after intravenous injection. | From injection of Gadobutrol up to 8 hours after injection. |
| Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group | Total body clearance of Gadobutrol in plasma corrected for body weight (L/h/kg) after intravenous injection. | From injection up to 8 hours after Gadobutrol injection |
| Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | Apparent volume of distribution at steady state expressed in L after intravenous injection. | From injection up to 8 hours after Gadobutrol injection |
| Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | Apparent volume of distribution at steady state corrected for body weight (L/h/kg) after intravenous injection. | From injection to 8 hours after Gadobutrol injection |
| Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group | Area under the concentration versus time curve from zero to infinity after intravenous injection expressed in µmol*h/L. | From injection to 8 hours after Gadobutrol injection |
| Terminal Elimination Half Life Estimates of Gadobutrol by Age Group | Terminal elimination half-life of Gadobutrol from plasma expressed in h and derived from the terminal slope of the concentration versus time curve. | From injection to 8 hours after Gadobutrol injection |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Excretion of Gadolinium as Percent of Administered Dose | Amount of gadolinium* excreted into urine during the collection interval 0 - 6 h post dose expressed as % of administered dose. *A metallic rare-earth element, used as a contrast medium for magnetic resonance imaging. | up to 6 hours after Gadobutrol injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | State of Vienna | 1090 | Austria | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19858730 | Result | Hahn G, Sorge I, Gruhn B, Glutig K, Hirsch W, Bhargava R, Furtner J, Born M, Schroder C, Ahlstrom H, Kaiser S, Moritz JD, Kunze CW, Shroff M, Stokland E, Trnkova ZJ, Schultze-Mosgau M, Reif S, Bacher-Stier C, Mentzel HJ. Pharmacokinetics and safety of gadobutrol-enhanced magnetic resonance imaging in pediatric patients. Invest Radiol. 2009 Dec;44(12):776-83. doi: 10.1097/RLI.0b013e3181bfe2d2. | |
| 22409261 |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
| FG001 | Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
| FG002 | Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
| BG001 | Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years |
| 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 | Plasma Clearance Estimates of Gadobutrol by Age Group | Total body clearance of Gadobutrol in plasma in L/h after intravenous injection. | Final pharmacokinetics (PK) analysis set | Posted | Median | Inter-Quartile Range | L/h | From injection of Gadobutrol up to 8 hours after injection. |
|
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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 | Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Meningitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
Originally, urine was collected up to 6 hours post injection in patients > 9 years. This was amended to patients of all age groups. As a result, urine was collected in 102 of 138 patients with gadobutrol injection (lowest rate in patients 2-6 years).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| C090600 | gadobutrol |
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| Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group | Mean residence time of Gadobutrol in plasma expressed in h. | From injection to 8 hours after Gadobutrol injection |
| Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group |
In the participants the technical adequacy (evaluability) of MR images was assessed on the following 4-point scale (1=not adequate [compromised quality], 2=partially adequate [evaluation possible], 3=adequate despite artifacts, 4=adequate with excellent quality). |
| Up to 1 hour after Gadobutrol injection |
| Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | In the participants qualitative overall contrast quality of post contrast images was assessed on the following 6-point scale (none, poor, moderate, good, excellent, not assessable). | up to 1 hour after Gadobutrol injection |
| Pre-Contrast Lesions by Location and by Age Group | Number of lesions on pre-contrast images by organ location and age group. | up to 1 hour after Gadobutrol injection |
| Post-Contrast Lesions by Location and by Age Group | Number of lesions on post-contrast images by organ location and age group. | up to 1 hour after Gadobutrol injection |
| Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | In the participants pre-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable). | up to 1 hour after Gadobutrol injection |
| Post-Contrast Delineation of Lesion/Vessel Border by Age Group | In the participants post-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable). | up to 1 hour after Gadobutrol injection |
| Pre-Contrast Lesion Characterization by Age Group | In the participants the internal morphology and structure of each pre-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable). | up to 1 hour after Gadobutrol injection |
| Post-Contrast Lesion Characterization by Age Group | In the participants the internal morphology and structure of each post-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable). | up to 1 hour after Gadobutrol injection |
| Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | In the participants the degree of contrast enhancement in each lesion/vessel was assessed on the following 5-point scale (1=no, 2=moderate, 3=good, 4=excellent, 5=not applicable). | up to 1 hour after Gadobutrol injection |
| Number of Participants With Change in Diagnostic Confidence by Age Group | In the participants the change in diagnostic confidence (additional diagnostic gain by the post-contrast scan) was assessed on the following 3-point scale (1=unchanged, 2=improved, 3=worsened). | up to 1 hour after Gadobutrol injection |
| Edmonton |
| Alberta |
| T6G 2B7 |
| Canada |
| Toronto | Ontario | M5G 1X8 | Canada |
| Erlangen | Bavaria | 91054 | Germany |
| Bonn | North Rhine-Westphalia | 53105 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Halle | Saxony-Anhalt | 06120 | Germany |
| Kiel | Schleswig-Holstein | 24103 | Germany |
| Kiel | Schleswig-Holstein | 24105 | Germany |
| Jena | Thuringia | 07740 | Germany |
| Gothenburg | 41485 | Sweden |
| Stockholm | 17176 | Sweden |
| Uppsala | 75185 | Sweden |
| Result |
| Reif S, Schultze-Mosgau M, Sutter G. From adults to children: simulation-based choice of an appropriate sparse-sampling schedule. Paediatr Drugs. 2012 Jun 1;14(3):189-200. doi: 10.2165/11595430-000000000-00000. |
| Drop-outs (Treatment never received) |
|
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
| BG002 | Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| OG002 | Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
| OG003 | Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
|
|
| Primary | Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group | Total body clearance of Gadobutrol in plasma corrected for body weight (L/h/kg) after intravenous injection. | Final PK analysis set | Posted | Median | Inter-Quartile Range | L/h/kg | From injection up to 8 hours after Gadobutrol injection |
|
|
|
| Primary | Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | Apparent volume of distribution at steady state expressed in L after intravenous injection. | Final PK analysis set | Posted | Median | Inter-Quartile Range | L | From injection up to 8 hours after Gadobutrol injection |
|
|
|
| Primary | Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group | Apparent volume of distribution at steady state corrected for body weight (L/h/kg) after intravenous injection. | Final PK analysis set | Posted | Median | Inter-Quartile Range | L/kg | From injection to 8 hours after Gadobutrol injection |
|
|
|
| Primary | Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group | Area under the concentration versus time curve from zero to infinity after intravenous injection expressed in µmol*h/L. | Final PK analysis set | Posted | Median | Inter-Quartile Range | µmol*h/L | From injection to 8 hours after Gadobutrol injection |
|
|
|
| Primary | Terminal Elimination Half Life Estimates of Gadobutrol by Age Group | Terminal elimination half-life of Gadobutrol from plasma expressed in h and derived from the terminal slope of the concentration versus time curve. | Final PK analysis set | Posted | Median | Inter-Quartile Range | hours | From injection to 8 hours after Gadobutrol injection |
|
|
|
| Primary | Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group | Mean residence time of Gadobutrol in plasma expressed in h. | Final PK analysis set | Posted | Median | Inter-Quartile Range | hours | From injection to 8 hours after Gadobutrol injection |
|
|
|
| Secondary | Urinary Excretion of Gadolinium as Percent of Administered Dose | Amount of gadolinium* excreted into urine during the collection interval 0 - 6 h post dose expressed as % of administered dose. *A metallic rare-earth element, used as a contrast medium for magnetic resonance imaging. | Valid for urinary analysis | Posted | Mean | Full Range | percentage of administered dose | up to 6 hours after Gadobutrol injection |
|
|
|
| Secondary | Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group | In the participants the technical adequacy (evaluability) of MR images was assessed on the following 4-point scale (1=not adequate [compromised quality], 2=partially adequate [evaluation possible], 3=adequate despite artifacts, 4=adequate with excellent quality). | FAS | Posted | Number | Participants | Up to 1 hour after Gadobutrol injection |
|
|
|
| Secondary | Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group | In the participants qualitative overall contrast quality of post contrast images was assessed on the following 6-point scale (none, poor, moderate, good, excellent, not assessable). | FAS | Posted | Number | Participants | up to 1 hour after Gadobutrol injection |
|
|
|
| Secondary | Pre-Contrast Lesions by Location and by Age Group | Number of lesions on pre-contrast images by organ location and age group. | FAS | Posted | Number | Lesions | up to 1 hour after Gadobutrol injection |
|
|
|
| Secondary | Post-Contrast Lesions by Location and by Age Group | Number of lesions on post-contrast images by organ location and age group. | FAS | Posted | Number | Lesions | up to 1 hour after Gadobutrol injection |
|
|
|
| Secondary | Pre-Contrast Delineation of Lesion/Vessel Border by Age Group | In the participants pre-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable). | FAS | Posted | Number | Lesions | up to 1 hour after Gadobutrol injection |
|
|
|
| Secondary | Post-Contrast Delineation of Lesion/Vessel Border by Age Group | In the participants post-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable). | FAS | Posted | Number | Lesions | up to 1 hour after Gadobutrol injection |
|
|
|
| Secondary | Pre-Contrast Lesion Characterization by Age Group | In the participants the internal morphology and structure of each pre-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable). | FAS | Posted | Number | Lesions | up to 1 hour after Gadobutrol injection |
|
|
|
| Secondary | Post-Contrast Lesion Characterization by Age Group | In the participants the internal morphology and structure of each post-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable). | FAS | Posted | Number | Lesions | up to 1 hour after Gadobutrol injection |
|
|
|
| Secondary | Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) | In the participants the degree of contrast enhancement in each lesion/vessel was assessed on the following 5-point scale (1=no, 2=moderate, 3=good, 4=excellent, 5=not applicable). | FAS | Posted | Number | Lesions | up to 1 hour after Gadobutrol injection |
|
|
|
| Secondary | Number of Participants With Change in Diagnostic Confidence by Age Group | In the participants the change in diagnostic confidence (additional diagnostic gain by the post-contrast scan) was assessed on the following 3-point scale (1=unchanged, 2=improved, 3=worsened). | FAS | Posted | Number | Participants | up to 1 hour after Gadobutrol injection |
|
|
|
| 1 |
| 46 |
| 17 |
| 46 |
| EG001 | Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection | 1 | 44 | 16 | 44 |
| EG002 | Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection | 0 | 48 | 16 | 48 |
| EG003 | Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection | 2 | 138 | 49 | 138 |
| Pneumonia | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Crystal urine | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Central line infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Leukocyturia | Renal and urinary disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
Not provided
| partially adequate (evaluation possible) |
|
| adequate despite artifacts |
|
| adequate with excellent quality |
|
| poor |
|
| moderate |
|
| good |
|
| excellent |
|
| not assessable |
|
| Liver |
|
| Brain |
|
| Vessel |
|
| Spine |
|
| Liver |
|
| Brain |
|
| Vessel |
|
| Spine |
|
| moderate |
|
| good |
|
| excellent |
|
| not assessable |
|
| moderate |
|
| good |
|
| excellent |
|
| not assessable |
|
| moderate |
|
| good |
|
| not applicable |
|
| moderate |
|
| good |
|
| not applicable |
|
| moderate |
|
| good |
|
| excellent |
|
| not applicable |
|
| unchanged |
|
| improved |
|
| worsened |
|