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| ID | Type | Description | Link |
|---|---|---|---|
| CONTROL I Study |
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An open-label, multi-center study to establish psoriasis control of moderate to severe plaque psoriasis with Raptiva therapy administered subcutaneously for 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efalizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efalizumab | Drug | Subjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Physician's Global Assessment (PGA) Ratings of "Excellent" or "Cleared" at Week 24 | The PGA rating was used to assess the global response of all psoriatic lesions by comparing subject's present condition to baseline photographs or body diagrams. The response was classified as Cleared: 100% improvement of all clinical signs and symptoms compared to baseline; Excellent: 75% to 99% improvement of all signs and symptoms compared to baseline; Good: 50% to 74% improvement of signs and symptoms compared to baseline; Fair: 25% to 49% improvement of signs and symptoms compared to baseline; Slight: 1% to 24% improvement of signs and symptoms compared to baseline; Unchanged: Clinical signs and symptoms unchanged from baseline and Worse: Clinical signs and symptoms deteriorated from baseline. | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Information Switzerland | Geneva | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20098510 | Result | Stengel FM, Petri V, Campbell GA, Dorantes GL, Lopez M, Galimberti RL, Valdez RP, de Arruda LF, Guerra MA, Chouela EN, Licu D; International IMP25161 Study Group. Control of Moderate-to-Severe Plaque Psoriasis with Efalizumab: 24-Week, Open-Label, Phase IIIb/IV Latin American Study Results. Arch Drug Inf. 2009 Dec;2(4):71-78. doi: 10.1111/j.1753-5174.2009.00024.x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Efalizumab | Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Efalizumab | Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects With Physician's Global Assessment (PGA) Ratings of "Excellent" or "Cleared" at Week 24 | The PGA rating was used to assess the global response of all psoriatic lesions by comparing subject's present condition to baseline photographs or body diagrams. The response was classified as Cleared: 100% improvement of all clinical signs and symptoms compared to baseline; Excellent: 75% to 99% improvement of all signs and symptoms compared to baseline; Good: 50% to 74% improvement of signs and symptoms compared to baseline; Fair: 25% to 49% improvement of signs and symptoms compared to baseline; Slight: 1% to 24% improvement of signs and symptoms compared to baseline; Unchanged: Clinical signs and symptoms unchanged from baseline and Worse: Clinical signs and symptoms deteriorated from baseline. | The Intent to Treat (ITT) population consisted of all subjects who received at least 1 dose of trial medication. | Posted | Number | 95% Confidence Interval | percentage of subjects | Week 24 |
|
|
|
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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 | Efalizumab | Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks. | 21 | 189 | 161 | 189 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Nail psoriasis | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Lumbar puncture headache | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Non-systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Injection site irritation | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Prostration | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Thirst | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Monarthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dactylitis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Intervertebral discitis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Condyloma acuminatum | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dental caries | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dermatophytosis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Nail candida | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Culture throat positive | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Peripheral occlusive disease | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Growth of eyelashes | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Genital discharge | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Peyronie's disease | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Vaginal disorder | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
| |
| Paraproteinaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Non-systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Merck KGaA Communication Center | Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany | +49-6151-72-5200 | service@merckgroup.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C472181 | efalizumab |
Not provided
Not provided
Not provided