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| ID | Type | Description | Link |
|---|---|---|---|
| REMICADEPSO3004 |
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The purpose of this study is to determine the superiority and efficacy of infliximab induction therapy in chinese participants with moderate to severe plaque-type psoriasis (scaly skin rash) compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial).
This is a double-blind (neither physician nor participant knows the treatment that the participant receives), multicenter (when more than one hospital or medical school team work on a medical research study) and placebo-controlled study of infliximab in participants with moderate to severe plaque-type psoriasis. All the eligible participants will be randomly assigned to infliximab and placebo groups. The infliximab group will receive 5 milligram per kilogram (mg/kg) infliximab infusions (a fluid or a medicine delivered into a vein by way of a needle) intravenously (into a vein) at Week 0, 2 and 6 in the induction treatment phase followed by maintenance regimen of the intervention every 8 weeks up to 26 weeks. Placebo infusions will also be given at Week 10, 12 and 16. The placebo group will receive placebo infusion at Week 0, 2, 6, 14 and 22. At Week 10, participants in placebo group will then receive infliximab induction therapy. Efficacy of the participants will primarily be evaluated by percentage of participants who achieve a Psoriasis Area and Severity Index 75 (PASI) response at Week 10. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab | Experimental | 5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab will be given at Week 10, 12 and 16. Total duration of treatment will be 26 weeks. |
|
| Placebo | Experimental | Placebo infusion, matched to infliximab will be given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants will receive 5 mg/kg infliximab intravenously. Placebo infusion will be again given at Week 14 and 22. Total duration of treatment will be 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo matched to infliximab given at Weeks 10, 12 and 16 in Infliximab arm and at Weeks 0, 2 and 6 in Placebo arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a Greater Than Equal to 75 Percent Response in Psoriasis Area and Severity Index (PASI) | The PASI score is based on the assessment of the erythema (e), induration (I), scaling (S), and the body is divided into 4 regions head, trunk, upper extremities, lower extremities. The assessment was done on 4-point scale (where, 0 = none, 1 = slight, 2 = moderate, 3 = severe, and 4 = very severe). The total possible score ranges from 0 (no disease) to 72 (maximal disease). Participants with no less than 75 percent relative Baseline improvement in the PASI scores are considered to be PASI 75 responders. | Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 10 | The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 26 | The DLQI is a dermatology-specific QOL instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd., China Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Infliximab | 5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks. |
| FG001 | Placebo | Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infliximab | 5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 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 |
| 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 Participants Who Achieved a Greater Than Equal to 75 Percent Response in Psoriasis Area and Severity Index (PASI) | The PASI score is based on the assessment of the erythema (e), induration (I), scaling (S), and the body is divided into 4 regions head, trunk, upper extremities, lower extremities. The assessment was done on 4-point scale (where, 0 = none, 1 = slight, 2 = moderate, 3 = severe, and 4 = very severe). The total possible score ranges from 0 (no disease) to 72 (maximal disease). Participants with no less than 75 percent relative Baseline improvement in the PASI scores are considered to be PASI 75 responders. | Intent to treat (ITT) population included all participants randomly assigned to Infliximab or placebo group. | Posted | Number | percentage of participants | Week 10 |
|
Baseline up to end of study (Week 26)
It was planned to collect and report adverse events as per the initial intervention received (either "Infliximab" or "Placebo"), instead of reporting by each intervention (that is, infliximab participants while on infliximab and infliximab participants while on 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 | Infliximab | 5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Tuberculosis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Antinuclear antibody positive | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Therapeutic Area Physician | Beijing, China R&D | +86 010 58218358 |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Infliximab | Drug | 5 mg/kg infusion given intravenously at Week 0,2,6 (induction treatment phase) and at Week 14 and 22 in maintenance phase in infliximab arm and at Week 12 and 16 in Placebo arm. |
|
|
| Baseline and Week 10 |
| Percentage of Participants With Static Physician Global Assessment (PGA) Score Less Than Equal to 1 at Week 10 | The Static physician global assessment (PGA) determines psoriasis lesions overall at given time point. Overall lesions graded for I (0= no evidence of plaque elevation to 5= severe plaque elevation), E (0 = no evidence of E, hyperpigmentation may be present to 5=dusky to deep red coloration), S (0 = no evidence of S to 5 = severe; very thick tenacious scale predominates). Sum of 3 scales divided by 3 gives final PGA score. Range for final score is 0 = cleared, except for residual discoloration, 1 = minimal, 2 = mild, 3=moderate, 4= marked and 5= severe; Scores should be rounded to the nearest whole number. If total ≤1.49, score = 1; if total≥ 1.50, score = 2. Percentage of participants with static PGA score <= 1 at week 10 were reported. | Week 10 |
| Baseline and Week 26 |
| Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | The AE is defined as any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); significant disability; congenital (occurred before birth, due to parent's genetic input) anomaly. | Baseline up to end of study (Week 26) |
| Beijng |
| China |
| Dalian | China |
| Jinan | China |
| Nanjing | China |
| Shanghai | China |
| Xi'an | China |
| Physician Decision |
|
| Withdrawal of informed consent |
|
| BG001 | Placebo | Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks. |
|
|
|
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 10 | The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL. | ITT population included all participants randomly assigned to Infliximab or placebo group. Here 'n' included those participants who were evaluable for this measure at specific time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 10 |
|
|
|
|
| Secondary | Percentage of Participants With Static Physician Global Assessment (PGA) Score Less Than Equal to 1 at Week 10 | The Static physician global assessment (PGA) determines psoriasis lesions overall at given time point. Overall lesions graded for I (0= no evidence of plaque elevation to 5= severe plaque elevation), E (0 = no evidence of E, hyperpigmentation may be present to 5=dusky to deep red coloration), S (0 = no evidence of S to 5 = severe; very thick tenacious scale predominates). Sum of 3 scales divided by 3 gives final PGA score. Range for final score is 0 = cleared, except for residual discoloration, 1 = minimal, 2 = mild, 3=moderate, 4= marked and 5= severe; Scores should be rounded to the nearest whole number. If total ≤1.49, score = 1; if total≥ 1.50, score = 2. Percentage of participants with static PGA score <= 1 at week 10 were reported. | ITT population included all participants randomly assigned to Infliximab or placebo group. | Posted | Number | percentage of participants | Week 10 |
|
|
|
|
| Other Pre-specified | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 26 | The DLQI is a dermatology-specific QOL instrument designed to assess impact of disease on a participants QOL. It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL. | ITT population included all participants randomly assigned to Infliximab or placebo group. 'n' included those participants who were evaluable for this measure at specific time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 26 |
|
|
|
|
| Other Pre-specified | Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | The AE is defined as any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); significant disability; congenital (occurred before birth, due to parent's genetic input) anomaly. | Safety Population included all participants randomly assigned to infliximab or placebo group. | Posted | Number | participants | Baseline up to end of study (Week 26) |
|
|
|
| 4 |
| 84 |
| 58 |
| 84 |
| EG001 | Placebo | Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks. | 1 | 45 | 28 | 45 |
| Tuberculous pleurisy | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Metastatic Pancreatic Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Liver diseases | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Double stranded DNA antibody positive | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Bilirubin conjugated increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Lipids increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pelvic infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Skin nodule | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Skin odour abnormal | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Breast mass | Reproductive system and breast disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Menstruation delayed | Reproductive system and breast disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Apraxia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Effulgent liver fire | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
Not provided
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |