Immediate Response With Adalimumab and Its Impact on Qual... | NCT01265823

Label	Type	Description	Intervention Names
Adalimumab	Experimental		Biological: Adalimumab

Name	Type	Description	Arm Group Labels	Other Names
Adalimumab	Biological	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 4. The improvement in PASI score was used as a measure of efficacy.	Week 4
Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 16	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy.	Week 16
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 4	Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.	Week 4
Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 16

Secondary Outcomes

Measure	Description	Time Frame
Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4	Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Able and willing to give written informed consent prior to any study related procedures and to comply with the requirements of the study protocol
Male and female subjects between 18 and 75 years old
Diagnosis of moderate to severe types I and II plaque psoriasis (Type I : symptoms onset before 40 years old; Type II: symptoms onset after 40 years old), with at least 6 months of duration
Documented moderate to severe plaque psoriasis based on Psoriasis Area and Severity Index (PASI) score >10
Subjects naïve to adalimumab therapy
Subject must be evaluated for active and latent tuberculosis (TB) infection by using a Purified Protein Derivative (PPD) skin test, chest x-ray (posterior to anterior (PA) and lateral views) and a detailed review of the subject's medical history. This screening must be negative
A negative pregnancy test (serum human chorionic gonadotrophin) for women of childbearing potential prior to start of study treatment. (Non-childbearing potential is defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy])
Able and willing to self-administer subcutaneous injections or have available a suitable person to administer subcutaneous injections
Subject is judged to be in generally good health as determined by the investigator

Exclusion Criteria:

Prior treatment with any investigational agent within 30 days, or five half-lives of the product, which ever is longer. Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half lives (whichever is longer) of the drug prior to study entry (Baseline Visit)
Subject has other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with the evaluation of psoriasis or compromise the subject's safety
Subject has a history of dysplasia, malignancy (including lymphoma and leukemia), or lymphoproliferative disease other than: a. Successfully and completely treated non-metastatic squamous or basal cell carcinoma of the skin with no recurrence within the last five years. b. Localized carcinoma in situ of the cervix or cervical dysplasia, with no recurrence within the last five years
Persistent or recurrent infections or severe infections requiring hospitalization or treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days, or oral antibiotics, oral antivirals or oral antifungals within 14 days prior to Baseline Visit
Other medical conditions: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure New York Heart Association (NYHA) III-IV, recent stroke (within three months), chronic leg ulcer and any other condition (e.g., indwelling urinary catheter) which, in the opinion of the investigator, may place the subject at risk
Previous diagnosis or signs highly indicative of central nervous system demyelinating diseases (e.g., optic neuritis, ataxia, apraxia)
History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB
Female subjects who are pregnant or breast-feeding
History of clinically significant drug or alcohol abuse in the last year
Subject started receiving a new topical therapy within the last four weeks prior to the Baseline visit for areas other than the palms, soles of feet, axilla and groin
Subject started being treated with ultraviolet B (UVB) phototherapy, within the last four weeks prior to the Baseline visit
Subject was treated with psoralen ultraviolet A (PUVA) phototherapy within the last four weeks prior to the Baseline visit
Subject has been initiated on a new systemic agent within the last four weeks prior to the Baseline visit
Patients with history of atopy
Patients with any other autoimmune disease such as systemic lupus erythematosus (SLE) , Sdx Sjögren, vasculitis etc
Known hypersensitivity to the excipients of adalimumab as stated in the label
Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study
Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Subject with any prior exposure to Tysabri (natalizumab), or Orencia (abatacept)
Subjects with positive immunologic test for hepatitis A, B or C (Positive test of any of the following: hepatitis A viral antibody immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab)
Subjects with a positive immunologic test for HIV determined by enzyme-linked immunosorbent assay (ELISA) method

Name	Affiliation	Role
Jose-Luis Canadas, Medical Director, MD	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 50942		Circuito Comercial Satelite			Mexico
Site Reference ID/Investigator# 40964

Label	URL
Related info	View source

ID	Title	Description
FG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

ID	Title	Description
BG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	BG000150

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 With Psoriasis Area and Severity Index (PASI)-75 Response at Week 4

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 4. The improvement in PASI score was used as a measure of efficacy.

Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.

Posted

Number

percentage of participants

Week 4

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000150

Title

Denominators

Categories

Title	Measurements
	OG00031

Primary

Percentage of Participants With Psoriasis Area and Severity Index (PASI)-75 Response at Week 16

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy.

Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.

Posted

Number

percentage of participants

Week 16

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000

Primary

Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 4

Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. A score <6 indicates that psoriasis has small or no effect at all on participant's life.

Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.

Posted

Number

percentage of participants

Week 4

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000

Primary

Percentage of Participants With a Dermatology Life Quality Index (DLQI) Score < 6 at Week 16

Intention-to-treat (ITT) population. Participants with missing scores were considered nonresponders.

Posted

Number

percentage of participants

Week 16

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000

Secondary

Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 4

Participants with evaluable data at given time points.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 4

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000

Secondary

Mean Score of Dermatology Life Quality Index (DLQI) at Baseline and Week 16

Participants with evaluable data at given time points.

Posted

Mean

Standard Deviation

units on a scale

Baseline, Week 16

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000

Secondary

Dermatology Life Quality Index (DLQI) Categories at Week 4

Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.

ITT population. Participants with missing scores were considered nonresponders.

Posted

Number

participants

Week 4

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000

Secondary

Dermatology Life Quality Index (DLQI) Categories at Week 16

Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participant's life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect.

ITT population. Participants with missing scores were considered nonresponders.

Posted

Number

participants

Week 16

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 4

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.

ITT population. Participants with missing scores were considered nonresponders.

Posted

Number

percentage of participants

Week 4

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI)-50, 90, 100 Responses at Week 16

PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-50, 90, and 100 responses are the percentage of participants who achieved at least a 50%, 90%, or 100% reduction (improvement) from baseline in PASI score at Week 4. 100% reduction was considered complete clearance of psoriasis.

ITT population. Participants with missing scores were considered nonresponders.

Posted

Number

percentage of participants

Week 16

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000

Secondary

Physician's Global Assessment (PGA) at Week 4

The PGA is a 7-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant. Categories are as follows: Severe = very marked plaque elevation, scaling, and/or erythema; Moderate to severe = marked plaque elevation, scaling, and/or erythema; Moderate = moderate plaque elevation, scaling, and/or erythema; Mild to moderate = intermediate between moderate and mild; Mild = slight plaque elevation, scaling, and/or erythema; Almost clear = intermediate between mild and clear; Clear = no signs of psoriasis (post-inflammatory hypopigmentation or hyperpigmentation could be present).

ITT population. Participants with missing scores were considered nonresponders.

Posted

Number

participants

Week 4

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000

Secondary

Physician's Global Assessment (PGA) at Week 16

ITT population. Participants with missing scores were considered nonresponders.

Posted

Number

participants

Week 16

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants

Secondary

Mean Lipid Profile, Triglycerides, and C-Reactive Protein (CRP) at Baseline and Week 16

Normal values: C-reactive protein (CRP) 0-0.79 mg/dL; cholesterol 30-199 mg/dL; high density lipoprotein (HDL) 40-100 mg/dL; very low density lipoprotein (VLDL) 0-34 mg/dL; low density lipoprotein (LDL) 20-99 mg/dL; triglycerides 50-149 mg/dL.

Participants with available data at given time points.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 16

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000

Secondary

Mean Homocysteine Levels at Baseline and Week 16

Normal values for homocysteine were 5-13.9 µmol/L.

Participants with available data at given time points.

Posted

Mean

Standard Deviation

µmol/L

Baseline, Week 16

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000143

Secondary

Percentage of Obese vs. Non-obese (Per Body Mass Index [BMI]) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16

The Body Mass Index (BMI) was used to determine the groups of participants who were overweight and who were considered obese. A BMI of 18.5 to 25 was considered normal range, 25 to 30 as overweight and 30 and above as obesity, in both men and women. Response to treatment in participants with obesity (based on Body Mass Index) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).

ITT Population

Posted

Number

percentage of participants

Week 16

ID	Title	Description
OG000	Adalimumab in Obese Participants	Obese participants were defined as having a BMI ≥ 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
OG001	Adalimumab in Non-obese Participants	Non-obese participants were defined as having a BMI < 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Secondary

Percentage of Obese vs. Non-obese (Per Waist-Hip Ratio) Participants Achieving a Psoriasis Area and Severity Index (PASI)-75 Response and a Total Dermatology Life Quality Index (DLQI) Score of <6 at Week 16

The Waist-Hip Ratio was used to determine the groups of participants who were overweight and who were considered obese. Obesity was defined as a ratio of >1 for men and >0.8 for women. Response to treatment in participants with obesity (based on Waist-Hip Ratio) versus those without obesity was assessed via PASI-75 response (see Outcome Measure 1 for details) and DLQI score of <6 (see Outcome Measure 3 for details).

ITT population

Posted

Number

percentage of participants

Week 16

ID	Title	Description
OG000	Adalimumab in Obese Participants	Obese participants were defined as those with a waist-hip ratio of >1 for men and >0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
OG001	Adalimumab in Non-obese Participants	Non-obese participants were defined as those with a waist-hip ratio of ≤1 for men and ≤0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Secondary

Serum Levels of Folic Acid at Baseline and Week 4

Normal values for folic acid were 3-15 ng/mL.

Participants with available data at given time points.

Posted

Mean

Standard Deviation

ng/mL

Baseline, Week 4

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000143

Secondary

Serum Levels of Vitamin B6 at Baseline and Week 4

Normal values for vitamin B6 were 18-175 nmol/L.

Participants with available data at given time points.

Posted

Mean

Standard Deviation

nmol/L

Baseline, Week 4

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000141

Secondary

Serum Levels of Vitamin B12 at Baseline and Week 4

Normal values for vitamin B12 were 200-1100 pg/mL.

Participants with available data at given time points.

Posted

Mean

Standard Deviation

pg/mL

Baseline, Week 4

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000143

Secondary

Serum Levels of Folic Acid at Baseline and Week 16

Normal values for folic acid were 3-15 ng/mL.

Participants with available data at given time point.

Posted

Mean

Standard Deviation

ng/mL

Baseline, Week 16

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000140

Secondary

Serum Levels of Vitamin B6 at Baseline and Week 16

Normal values for vitamin B6 were 18-175 nmol/L.

Participants with available data at given time points.

Posted

Mean

Standard Deviation

nmol/L

Baseline, Week 16

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000138

Secondary

Serum Levels of Vitamin B12 at Baseline and Week 16

Normal values for vitamin B12 were 200-1100 pg/mL.

Participants with available data at given time points.

Posted

Mean

Standard Deviation

pg/mL

Baseline, Week 16

ID	Title	Description
OG000	Adalimumab	Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.

Units	Counts
Participants	OG000140

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected150 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Polycythemia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Aortic arteriosclerosis	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Chest pain precordial	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Hypertension aggravated	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Otitis externa	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Otitis media	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Corneal injury	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Cholelithiasis	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected150 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Flatulence	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected150 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Gastrointestinal infection	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected150 at risk
Nausea	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Oral infection	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Vomiting	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Calculus urethral	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Nefrolithiasis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Penis disorder	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Prostatitis	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Urinary tract infection	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Urinary tract pain	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Vaginal infection	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
C-Reactive Protein increase	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected150 at risk
Diabetes	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00016 affected150 at risk
Hypertransaminasemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Hypertriglyceridemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected150 at risk
Hypervitaminosis B12	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 affected150 at risk
Hypervitaminosis B6	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected150 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected150 at risk
Weight loss	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Ankle sprain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00010 affected150 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Joint injury	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Anxiety	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Seizures	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Depressed mood	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Depression	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Dizziness	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Headache	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0008 affected150 at risk
Pharyngitis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 affected150 at risk
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00017 affected150 at risk
Cold sores (herpetic)	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Folliculitis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Papillomatosis	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Application site pain and/or pruritus	General disorders	MedDRA 14.1	Systematic Assessment	EG0007 affected150 at risk
Fatigue	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 affected150 at risk
Fever	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Pruritus generalized	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Psoriasis aggravated	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 affected150 at risk
Skin disorder	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk
Skin nodule	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 affected150 at risk

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins