Not provided
Not provided
Not provided
Not provided
The study was terminated after the European Medicines Agency recommended to suspend the marketing authorisation of Raptiva in the European Union
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the safety of transitioning subjects to Raptiva therapy from standard oral systemic or phototherapy by overlapping with Raptiva whilst tapering the initial systemic therapy or phototherapy dose.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efalizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efalizumab - anti CD11a recombinant human monoclonal antibody (mAb) | Drug | Each subject will receive an initial conditioning dose of 0.7 mg/kg/week and then will continue treatment at a dose of 1mg/kg/week for up to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Hematology - Hematocrit | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Hematology - Hemoglobin | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Hematology - Red Blood Cell Count | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Hematology - White Blood Cell Count | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Hematology - Neutrophils | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Hematology - Eosinophils | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Hematology - Basophils | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Hematology - Monocytes | Blood samples were taken for clinical laboratory testing |
| Measure | Description | Time Frame |
|---|---|---|
| Static Physician's Global Assessment (sPGA) | Number of subjects who achieve an Static Physician's Global Assessment (sPGA) rating of clear; minimal; mild; moderate; severe; or very severe at Week 12 (Day 85). | 12 Weeks/Early Termination |
Not provided
Inclusion Criteria:
No primary vaccinations (e.g., tetanus, booster, influenza vaccine) for at least 14 days prior to first dose of study drug.For the purposes of this trial, women of childbearing potential is defined as: "All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive."
Exclusion Criteria:
Any contra-indication to Raptiva, according to the Investigator Brochure, or as follows:
Simultaneous participation in another clinical trial.
Subjects experiencing a psoriasis exacerbation during screening period.
Subjects who have previously been on Raptiva treatment who withdrew due to lack of efficacy or an adverse event. If withdrawal was due to another non-drug reason (vaccination, or infection) then the subject can be included in this study.
History of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
History of thrombocytopenia, haemolytic anaemia or clinically significant anaemia.
Hepatic enzyme levels =/>3 times the upper limit of normal or serum creatinine level =/>2 times the upper limit of normal.
Pregnant or breast-feeding.
Any medical condition (prior or existing) that, in the judgment of the investigator or sponsor, could jeopardize the subject's safety following exposure to study drug.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicole Selenko-Gebauer | Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Probity Medical Research | City Waterloo | Ontario | N2J 1C4 | Canada |
Subjects were to be screened for study eligibility within 14 days before Day 1
Date of first subject first visit: 22 January 2008 Date of last subject last visit: 21 April 2009 Subjects were enrolled at 13 study centers in 2 countries, including 10 study centers in Canada and 3 study centers in the Netherlands.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Efalizumab | Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Efalizumab | Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection |
| 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 | Hematology - Hematocrit | Blood samples were taken for clinical laboratory testing | Safety Population - 4 participants missing values | Posted | Mean | Standard Deviation | packed cell volume | Week 12 / Early Termination |
|
|
12 Weeks
'Other Adverse Events' table shows the number of participants experiencing any adverse event and the listing shows all treatment emergent adverse events occuring above the threshold value in the Safety Population
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Efalizumab | Each subject received an initial conditioning dose of efalizumab of 0.7 mg/kg/week and then was to continue treatment at a dose of 1 mg/kg/week for up to 12 weeks. Efalizumab was administered by subcutaneous injection |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Serono S.A., a division of Merck KGaA | +49-6151-72-5200 | service@merckgroup.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Week 12 / Early Termination |
| Hematology - Lymphocytes | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Hematology - Platelet Count | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Biochemistry - Sodium | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Biochemistry - Potassium | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Biochemistry - Creatinine | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Biochemistry - Total Bilirubin | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Biochemistry - Aspartate Transaminase (AST) | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Biochemistry - Alanine Transaminase (ALT) | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Biochemistry - Alkaline Phosphatase | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Biochemistry - Glutamyl Transferase | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Biochemistry - Urea | Blood samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Biochemistry - C-Reactive Protein (CRP) | Blood samples were taken for clinical laboratory testing of the numbers of participants with CRP values <3 mg/L, 3-6 mg/L, and >6 mg/L | Week 12 / Early Termination |
| Urinalysis - pH | Urine samples were taken for clinical laboratory testing | Week 12 / Early Termination |
| Urinalysis - Protein | Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine | Week 12 / Early Termination |
| Urinalysis - Ketones | Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine | Week 12 / Early Termination |
| Urinalysis - Glucose | Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine | Week 12 / Early Termination |
| Urinalysis - Blood | Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine | Week 12 / Early Termination |
| Urinalysis - Nitrite | Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine | Week 12 / Early Termination |
| Urinalysis - Leukocytes Esterase | Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine | Week 12 / Early Termination |
| Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis | Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above | Week 12 / Early Termination |
| Suspension of the study by sponsor |
|
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| static Physician's Global Assessment (sPGA) | Numbers of participants with sPGA ratings of clear; minimal; mild; moderate; severe; or very severe | Number | participants |
|
| Biochemistry - C-Reactive Protein (CRP) | Numbers of participants with CRP values <3 mg/L, 3-6 mg/L, and >6 mg/L | Number | participants |
|
| Biochemistry - Alanine Transaminase (ALT) | Mean | Standard Deviation | IU/L |
|
| Biochemistry - Alkaline Phosphatase | Mean | Standard Deviation | IU/L |
|
| Biochemistry - Aspartate Transaminase (AST) | Mean | Standard Deviation | IU/L |
|
| Biochemistry - Creatinine | Mean | Standard Deviation | μmol/L |
|
| Biochemistry - Glutamyl Transferase | Mean | Standard Deviation | IU/L |
|
| Biochemistry - Potassium | Mean | Standard Deviation | mmol/L |
|
| Biochemistry - Values: Sodium | Mean | Standard Deviation | mmol/L |
|
| Biochemistry - Total Bilirubin | Mean | Standard Deviation | μmol/L |
|
| Biochemistry - Urea | Mean | Standard Deviation | mmol/L |
|
| Hematology - Hematocrit | Mean | Standard Deviation | packed cell volume |
|
| Hematology - Hemoglobin | Mean | Standard Deviation | g/L |
|
| Hematology - Red Blood Cell Count | Mean | Standard Deviation | x10^12/L |
|
| Hematology - White Blood Cell Count | Mean | Standard Deviation | x10^9/L |
|
| Hematology - Basophils | Mean | Standard Deviation | x10^9/L |
|
| Hematology - Eosinophils | Mean | Standard Deviation | x10^9/L |
|
| Hematology - Lymphocytes | Mean | Standard Deviation | x10^9/L |
|
| Hematology - Monocytes | Mean | Standard Deviation | x10^9/L |
|
| Hematology - Neutrophils | Mean | Standard Deviation | x10^9/L |
|
| Hematology - Platelet Count | Mean | Standard Deviation | x10^9/L |
|
| Urinalysis - Glucose | Number of participants with or without glucose detected in urine | Number | participants |
|
| Urinalysis - Ketones | Number of participants with or without ketones detected in urine | Number | participants |
|
| Urinalysis - Values - Nitrite | Number of participants with or without nitrite detected in urine | Number | participants |
|
| Urinalysis - Leukocytes Esterase | Number of participants with or without leukocytes esterase detected in urine | Number | participants |
|
| Urinalysis - Values - Protein | Number | participants |
|
| Urinalysis - Blood | Number of participants with or without blood detected in urine | Number | participants |
|
| Urinalysis - pH | Mean | Standard Deviation | pH units |
|
|
| Secondary | Static Physician's Global Assessment (sPGA) | Number of subjects who achieve an Static Physician's Global Assessment (sPGA) rating of clear; minimal; mild; moderate; severe; or very severe at Week 12 (Day 85). | Safety Population | Posted | Number | participants | 12 Weeks/Early Termination |
|
|
|
| Primary | Hematology - Hemoglobin | Blood samples were taken for clinical laboratory testing | Safety Population - 3 participants missing values | Posted | Mean | Standard Deviation | g/L | Week 12 / Early Termination |
|
|
|
| Primary | Hematology - Red Blood Cell Count | Blood samples were taken for clinical laboratory testing | Safety Population - 3 participants missing values | Posted | Mean | Standard Deviation | x10^12/L | Week 12 / Early Termination |
|
|
|
| Primary | Hematology - White Blood Cell Count | Blood samples were taken for clinical laboratory testing | Safety Population - 3 participants missing values | Posted | Mean | Standard Deviation | x10^9/L | Week 12 / Early Termination |
|
|
|
| Primary | Hematology - Neutrophils | Blood samples were taken for clinical laboratory testing | Safety Population - 3 participants missing values | Posted | Mean | Standard Deviation | x10^9/L | Week 12 / Early Termination |
|
|
|
| Primary | Hematology - Eosinophils | Blood samples were taken for clinical laboratory testing | Safety Population - 3 participants missing values | Posted | Mean | Standard Deviation | x10^9/L | Week 12 / Early Termination |
|
|
|
| Primary | Hematology - Basophils | Blood samples were taken for clinical laboratory testing | Safety Population - 3 participants missing values | Posted | Mean | Standard Deviation | x10^9/L | Week 12 / Early Termination |
|
|
|
| Primary | Hematology - Monocytes | Blood samples were taken for clinical laboratory testing | Safety Population - 3 participants missing values | Posted | Mean | Standard Deviation | x10^9/L | Week 12 / Early Termination |
|
|
|
| Primary | Hematology - Lymphocytes | Blood samples were taken for clinical laboratory testing | Safety Population - 3 participants missing values | Posted | Mean | Standard Deviation | x10^9/L | Week 12 / Early Termination |
|
|
|
| Primary | Hematology - Platelet Count | Blood samples were taken for clinical laboratory testing | Safety Population - 4 participants missing values | Posted | Mean | Standard Deviation | x10^9/L | Week 12 / Early Termination |
|
|
|
| Primary | Biochemistry - Sodium | Blood samples were taken for clinical laboratory testing | Safety Population - 1 participant missing values | Posted | Mean | Standard Deviation | mmol/L | Week 12 / Early Termination |
|
|
|
| Primary | Biochemistry - Potassium | Blood samples were taken for clinical laboratory testing | Safety Population - 1 participant missing values | Posted | Mean | Standard Deviation | mmol/L | Week 12 / Early Termination |
|
|
|
| Primary | Biochemistry - Creatinine | Blood samples were taken for clinical laboratory testing | Safety Population - 1 participant missing values | Posted | Mean | Standard Deviation | μmol/L | Week 12 / Early Termination |
|
|
|
| Primary | Biochemistry - Total Bilirubin | Blood samples were taken for clinical laboratory testing | Safety Population - 1 participant missing values | Posted | Mean | Standard Deviation | μmol/L | Week 12 / Early Termination |
|
|
|
| Primary | Biochemistry - Aspartate Transaminase (AST) | Blood samples were taken for clinical laboratory testing | Safety Population - 2 participants missing values | Posted | Mean | Standard Deviation | IU/L | Week 12 / Early Termination |
|
|
|
| Primary | Biochemistry - Alanine Transaminase (ALT) | Blood samples were taken for clinical laboratory testing | Safety Population - 1 participant missing values | Posted | Mean | Standard Deviation | IU/L | Week 12 / Early Termination |
|
|
|
| Primary | Biochemistry - Alkaline Phosphatase | Blood samples were taken for clinical laboratory testing | Safety Population - 1 participant missing values | Posted | Mean | Standard Deviation | IU/L | Week 12 / Early Termination |
|
|
|
| Primary | Biochemistry - Glutamyl Transferase | Blood samples were taken for clinical laboratory testing | Safety Population - 1 participant missing values | Posted | Mean | Standard Deviation | IU/L | Week 12 / Early Termination |
|
|
|
| Primary | Biochemistry - Urea | Blood samples were taken for clinical laboratory testing | Safety Population - 1 participant missing values | Posted | Mean | Standard Deviation | mmol/L | Week 12 / Early Termination |
|
|
|
| Primary | Biochemistry - C-Reactive Protein (CRP) | Blood samples were taken for clinical laboratory testing of the numbers of participants with CRP values <3 mg/L, 3-6 mg/L, and >6 mg/L | Safety Population - 1 participant with missing values | Posted | Number | participants | Week 12 / Early Termination |
|
|
|
| Primary | Urinalysis - pH | Urine samples were taken for clinical laboratory testing | Safety Population - 3 participants missing values | Posted | Mean | Standard Deviation | pH units | Week 12 / Early Termination |
|
|
|
| Primary | Urinalysis - Protein | Urine samples were taken for clinical laboratory testing of the number of participants with or without protein in urine | Posted | Number | participants | Week 12 / Early Termination |
|
|
|
| Primary | Urinalysis - Ketones | Urine samples were taken for clinical laboratory testing of the number of participants with or without ketones in urine | Posted | Number | participants | Week 12 / Early Termination |
|
|
|
| Primary | Urinalysis - Glucose | Urine samples were taken for clinical laboratory testing of the number of participants with or without glucose in urine | Safety Population - 3 participants with missing values | Posted | Number | participants | Week 12 / Early Termination |
|
|
|
| Primary | Urinalysis - Blood | Urine samples were taken for clinical laboratory testing of the number of participants with or without blood in urine | Safety Population - 3 participants with missing values | Posted | Number | participants | Week 12 / Early Termination |
|
|
|
| Primary | Urinalysis - Nitrite | Urine samples were taken for clinical laboratory testing of the number of participants with or without nitrite in urine | Safety Population - 3 participants with missing values | Posted | Number | participants | Week 12 / Early Termination |
|
|
|
| Primary | Urinalysis - Leukocytes Esterase | Urine samples were taken for clinical laboratory testing of the number of participants with or without leukocytes esterase in urine | Safety Population - 3 participants with missing values | Posted | Number | participants | Week 12 / Early Termination |
|
|
|
| Primary | Adverse Events, Serious Adverse Events, and Laboratory Data (Haematology and Biochemistry) and Urinalysis | Information on adverse events are displayed in the adverse events section. Information laboratory data and urinalysis findings are displayed individually above | Not Posted | Week 12 / Early Termination |
| 0 |
| 70 |
| 50 |
| 70 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (11.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (11.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (11.0) | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Sweat gland infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Vascular occlusion | Vascular disorders | MedDRA (11.0) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (11.0) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (11.0) | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
|
Not provided
| Title | Measurements |
|---|
|
| Moderate |
|
| Severe |
|
| Very Severe |
|
| Title | Measurements |
|---|---|
|