Extension of Prior Study Evaluating Safety and Tolerabili... | NCT00235989

NCT00235989

ID	Type	Description	Link
307320	Other Identifier	Company internal
Beyond	Other Identifier	Company internal

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ET: IFNB-1b 250 mcg => 250 mcg	Active Comparator	Extension Treatment 250 mcg continued	Drug: Interferon beta 1b (Betaseron, BAY86-5046)
ET: IFNB-1b 500 mcg => 250 mcg	Experimental	Extension Treatment 500 mcg reduced to 250 mcg	Drug: Interferon beta 1b (Betaseron, BAY86-5046)
ET: IFNB-1b 500 mcg => 500 mcg	Experimental	Extension Treatment 500 mcg continued	Drug: Interferon beta 1b (Betaseron, BAY86-5046)
ET: IFNB-1b 250 mcg => 500 mcg	Experimental	Extension Treatment 250 mcg increased to 500 mcg	Drug: Interferon beta 1b (Betaseron, BAY86-5046)

Name	Type	Description	Arm Group Labels	Other Names
Interferon beta 1b (Betaseron, BAY86-5046)	Drug	250 mcg administered s.c.(subcutaneous) every other day	ET: IFNB-1b 250 mcg => 250 mcg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities	Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was reported as a serious adverse event). Liver and bone marrow abnormalities are measured by lab tests.	At End of Study Visit (week 234)

Secondary Outcomes

Measure	Description	Time Frame
Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b	Serum samples for analysis of NAbs to interferon (IFN) beta-1b were collected in Study 307000A. In the extension study, NAbs were also monitored for information on persistence or resolution. Serum samples of about 6 mL for NAbs were drawn at Weeks 10, 24, 52, 78, 104 130, 156, 182, 208, 234, 260, 286 or the EOS visit. (NU/ml=neutralizing units/ml).

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California	90095-1721	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	ET: IFNB-1b 250 mcg => 250 mcg	Extension Treatment 250 mcg continued
FG001	ET: IFNB-1b 500 mcg => 250 mcg	Extension Treatment 500 mcg reduced to 250 mcg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00436 subjects
FG00527 subjects

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	ET: IFNB-1b 250 mcg => 250 mcg	Extension Treatment 250 mcg continued
BG001	ET: IFNB-1b 500 mcg => 250 mcg	Extension Treatment 500 mcg reduced to 250 mcg
BG002	ET: IFNB-1b 500 mcg => 500 mcg	Extension Treatment 500 mcg continued
BG003	ET: IFNB-1b 250 mcg => 500 mcg	Extension Treatment 250 mcg increased to 500 mcg
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00016 BG0016 BG00219 BG00320 BG00461

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00037.8± 9.22 BG00132.2± 6.79 BG00238.8± 7.57 BG003

Age, Customized

Number

participants

Title

Denominators

Categories

>20-30 years

Title	Measurements
	BG0003 BG0012 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00014 BG0013 BG002

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

Safety and Tolerability as Defined by the Number of Subjects With Flu-like Syndrome, Fever, Myalgia, Injection Site Reactions, Injection Site Reactions Pain, Asthenia, Headache, Liver Function Abnormalities, and Bone Marrow Function Abnormalities

Outcome measures are given as the number of patients with common toxicity by the Common Toxicity Criteria (CTC). Toxicity grading is: Grade 1: no study drug action recommended, Grade 2: Dose reduction or interruption of study treatment should be considered (grade 2 Lymphocyte toxicity required no study drug action), Grade 3: Dose reduction or interruption should be considered; interruption is recommended, and Grade 4: Interruption of study drug is recommended (Grade 4 laboratory toxicity was reported as a serious adverse event). Liver and bone marrow abnormalities are measured by lab tests.

The statistical analysis was descriptive. For Liver Function Toxicity grading, the total number of patients for 250 micrograms (mcg) - 500 mcg group was 19 instead of 20 for all analyses.

Posted

Number

participants

At End of Study Visit (week 234)

ID	Title	Description
OG000	ET: IFNB-1b 250 mcg => 250 mcg	Extension Treatment 250 mcg continued
OG001	ET: IFNB-1b 500 mcg => 250 mcg	Extension Treatment 500 mcg reduced to 250 mcg
OG002	ET: IFNB-1b 500 mcg => 500 mcg	Extension Treatment 500 mcg continued
OG003	ET: IFNB-1b 250 mcg => 500 mcg	Extension Treatment 250 mcg increased to 500 mcg

Units	Counts
Participants	OG00016 OG0016 OG00219 OG003

Title

Denominators

Categories

Incidence of flu-like syndrome

Title	Measurements
	OG0001 OG0011 OG0024 OG003

Secondary

Frequency (Number of Patients Per Group Defined by Cut Off Values and Per Treatment Arm) of Neutralizing Antibody (NAb) Titer to IFNB-1b

Serum samples for analysis of NAbs to interferon (IFN) beta-1b were collected in Study 307000A. In the extension study, NAbs were also monitored for information on persistence or resolution. Serum samples of about 6 mL for NAbs were drawn at Weeks 10, 24, 52, 78, 104 130, 156, 182, 208, 234, 260, 286 or the EOS visit. (NU/ml=neutralizing units/ml).

For the NAb analyses data were provided for 40 patients instead of 61 for week 234. Twenty-one patients had no data at this visit.The entries in the table are the number of patients with positive titer in the extension treatment cohorts for the three cutoff titer values. The analyses provide frequencies of positive titers.

Posted

Number

participants

At End of Study Visit (week 234)

ID	Title	Description
OG000	ET: IFNB-1b 250 mcg => 250 mcg	Extension Treatment 250 mcg continued
OG001	ET: IFNB-1b 500 mcg => 250 mcg	Extension Treatment 500 mcg reduced to 250 mcg
OG002	ET: IFNB-1b 500 mcg => 500 mcg	Extension Treatment 500 mcg continued

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ET: IFNB-1b 250 mcg => 250 mcg	Extension Treatment 250 mcg continued	2	16	15	16
EG001	ET: IFNB-1b 500 mcg => 250 mcg	Extension Treatment 500 mcg reduced to 250 mcg	0	6	6	6
EG002	ET: IFNB-1b 500 mcg => 500 mcg	Extension Treatment 500 mcg continued	9	19	19	19
EG003	ET: IFNB-1b 250 mcg => 500 mcg	Extension Treatment 250 mcg increased to 500 mcg	4	20	20	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Pain	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG0030 affected20 at risk
Chills	General disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Fever	General disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Necrosis	General disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Sepsis	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Surgery	Surgical and medical procedures	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Cerebral Ischemia	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Cerebrovascular Accident	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Myocardial Infarct	Cardiac disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Occlusion	Vascular disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Pericarditis	Cardiac disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Peripheral Vascular Disorder	Vascular disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Pulmonary Embolus	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Supraventricular Tachycardia	Cardiac disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Cholelithiasis	Hepatobiliary disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Esophagitis	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Gastrointestinal Disorder	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Nausea	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Rectal Disorder	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Vomiting	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Joint Disorder	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Grand Mal Convulsion	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Headache	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Multiple Sclerosis	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Bronchitis	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Lung Disorder	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Lung Edema	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Pneumonia	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Breast Enlargement	Reproductive system and breast disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Otitis Media	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Endometrial Disorder	Reproductive system and breast disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Kidney Calculus	Renal and urinary disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Pyelonephritis	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Pain	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0011 affected6 at risk EG0023 affected19 at risk EG0031 affected20 at risk
Abscess	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Accidental Injury	Injury, poisoning and procedural complications	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0024 affected19 at risk EG003
Allergic Reaction	Immune system disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0023 affected19 at risk EG003
Ashthenia	General disorders	HARTS 2.3	Non-systematic Assessment	EG0004 affected16 at risk EG0011 affected6 at risk EG0022 affected19 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Chills	General disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0023 affected19 at risk EG003
Cyst	General disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0023 affected19 at risk EG003
Face Edema	General disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Fever	General disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Flu Syndrom	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0011 affected6 at risk EG0024 affected19 at risk EG003
Heaviness in Extremities	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Hernia	General disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Hormone Level altered	Investigations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Infection	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Laboratory Test abnormal	Investigations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Malaise	General disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Pain	General disorders	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0012 affected6 at risk EG0024 affected19 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0003 affected16 at risk EG0010 affected6 at risk EG0025 affected19 at risk EG003
Pelvic Pain	Reproductive system and breast disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Surgery	Surgical and medical procedures	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Cardiomegaly	Cardiac disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Cardiovascular Disorder	Cardiac disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Cerebral Infarct	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Chest Pain	General disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Hypertension	Vascular disorders	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Migraine	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0024 affected19 at risk EG003
Pericarditis	Cardiac disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Peripheral Vascular Disorder	Vascular disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected6 at risk EG0020 affected19 at risk EG003
Syncope	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Vascular Disorder	Vascular disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Anorexia	Metabolism and nutrition disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Constipation	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0011 affected6 at risk EG0021 affected19 at risk EG003
Diarrhea	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0023 affected19 at risk EG003
Duodenitis	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Dyspepsia	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0003 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Dysphagia	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Esophageal Ulcer	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Fecal Incontinence	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Gastritis	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Gastroenteritis	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0023 affected19 at risk EG003
Ginigivitis	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Gum Disorder	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Hemorrhoids	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected6 at risk EG0020 affected19 at risk EG003
Increased Salivation	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Nausea	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0003 affected16 at risk EG0010 affected6 at risk EG0024 affected19 at risk EG003
Rectal Bleeding	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Peridontal Abscess	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Rectal Disorder	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Sore Throat	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Tongue Pain	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Tooth Caries	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Tooth Disorder	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Vomiting	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Adrenal Disorder	Endocrine disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Diabetes Mellitus	Metabolism and nutrition disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Goiter	Endocrine disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Hypothyreodism	Endocrine disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Anemia	Blood and lymphatic system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Decreased Hemoglobin	Investigations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Ecchymosis	Skin and subcutaneous tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Leukopenia	Blood and lymphatic system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Normocytic Anemia	Blood and lymphatic system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Platelet Count decreased	Investigations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Injection Site Abscess	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Injection Site Necrosis	General disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Injection Site Pain	General disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Injection Site Reaction	General disorders	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0013 affected6 at risk EG0024 affected19 at risk EG003
Avitaminosis	Metabolism and nutrition disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Edema	General disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Gamma-GT increased	Investigations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Hypercalcemia	Metabolism and nutrition disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Hypercholesterolemia	Metabolism and nutrition disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0023 affected19 at risk EG003
Hyperlipemia	Metabolism and nutrition disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Peripheral Edema	General disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
SGOT increased	Investigations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
SGPT increased	Investigations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Uremia	Renal and urinary disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Weight Gain	Investigations	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Weight Loss	Investigations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Bone Disorder	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Bone Fracture (not spontaneous)	Injury, poisoning and procedural complications	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Joint Disorder	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Muscle Cramps	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0003 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Myasthenia	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0003 affected16 at risk EG0012 affected6 at risk EG0023 affected19 at risk EG003
Tendon Disorder	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Twitching	Musculoskeletal and connective tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Abnormal Gait	General disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Amnesia	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Anxiety	Psychiatric disorders	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0011 affected6 at risk EG0022 affected19 at risk EG003
Ataxia	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0004 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Confusion	Psychiatric disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Depression	Psychiatric disorders	HARTS 2.3	Non-systematic Assessment	EG0004 affected16 at risk EG0013 affected6 at risk EG0024 affected19 at risk EG003
Dizziness	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0023 affected19 at risk EG003
Dry Mouth	Gastrointestinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Dysarthria	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Emotional Lability	Psychiatric disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected6 at risk EG0020 affected19 at risk EG003
Foot Drop	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Headache	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Hot Flashes	Vascular disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Hypalgesia	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0023 affected19 at risk EG003
Hyperkinesia	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Hypertonia	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0003 affected16 at risk EG0010 affected6 at risk EG0023 affected19 at risk EG003
Hypesthesia	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0005 affected16 at risk EG0013 affected6 at risk EG0027 affected19 at risk EG003
Incoordination	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Insomnia	Psychiatric disorders	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0011 affected6 at risk EG0023 affected19 at risk EG003
Libido decreased	Psychiatric disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Multiple Sclerosis	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0004 affected16 at risk EG0013 affected6 at risk EG0022 affected19 at risk EG003
Nervousness	Psychiatric disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Neuralgia	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Neuropathy	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Nystagmus	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Ophthalmoplegia	Eye disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Paresthesia	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0005 affected16 at risk EG0013 affected6 at risk EG0027 affected19 at risk EG003
Reflexes decreased	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Reflexes increased	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Somnolence	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Speech Disorder	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Sweating increased	Skin and subcutaneous tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Thinking abnormal	Psychiatric disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Tremor	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0011 affected6 at risk EG0020 affected19 at risk EG003
Vertigo	Ear and labyrinth disorders	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Apnea	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Bronchitis	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0004 affected16 at risk EG0011 affected6 at risk EG0023 affected19 at risk EG003
Cough increased	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Lung Disorder	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Nasal Septum Disorder	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Pharyngitis	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Pleural Disorder	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Pneumonia	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Respiratory Disorder	Respiratory, thoracic and mediastinal disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Rhinitis	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Sinusitis	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0011 affected6 at risk EG0025 affected19 at risk EG003
Upper Respiratory Infection	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0005 affected16 at risk EG0011 affected6 at risk EG0022 affected19 at risk EG003
Acne	Skin and subcutaneous tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Breast Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Female Lactation	Reproductive system and breast disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Fungal Dermatitis	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Petechial Rash	Skin and subcutaneous tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Rash	Skin and subcutaneous tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Skin Benign Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Skin Discoloration	Skin and subcutaneous tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Skin Disorder	Skin and subcutaneous tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Skin Necrosis	Skin and subcutaneous tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Skin Ulcer	Skin and subcutaneous tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Blurred Vision	Eye disorders	HARTS 2.3	Non-systematic Assessment	EG0002 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Deafness	Ear and labyrinth disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Diplopia	Eye disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Ear Disorder	Ear and labyrinth disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Ear Pain	Ear and labyrinth disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Eye Disorder	Eye disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected6 at risk EG0020 affected19 at risk EG003
Eye Pain	Eye disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0023 affected19 at risk EG003
Optic Neuritis	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Otitis Media	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Ptosis	Eye disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Pupillary Disorder	Eye disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Refraction Disorder	Eye disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Retinal Disorder	Eye disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Taste Perversion	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Visual Field Defect	Nervous system disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Cystitis	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Dysmenorrhea	Reproductive system and breast disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Dyspareunia	Reproductive system and breast disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Genital Leukoplakia	Reproductive system and breast disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Impotence	Reproductive system and breast disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Increased Urinary Frequency	Renal and urinary disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0011 affected6 at risk EG0020 affected19 at risk EG003
Kidney Calculus	Renal and urinary disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0022 affected19 at risk EG003
Leukorrhea	Reproductive system and breast disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Menstrual Disorder	Reproductive system and breast disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Papanicolaou Smear suspicious	Investigations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Urethritis	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected6 at risk EG0020 affected19 at risk EG003
Urinary Incontinence	Renal and urinary disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Urinary Retention	Renal and urinary disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Urinary Tract Disorder	Renal and urinary disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Urinary Tract Infection	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0004 affected16 at risk EG0010 affected6 at risk EG0026 affected19 at risk EG003
Urinary Urgency	Renal and urinary disorders	HARTS 2.3	Non-systematic Assessment	EG0001 affected16 at risk EG0011 affected6 at risk EG0020 affected19 at risk EG003
Urination impaired	Renal and urinary disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0011 affected6 at risk EG0021 affected19 at risk EG003
Vaginitis	Infections and infestations	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Vulvovaginal Disorder	Reproductive system and breast disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003
Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	HARTS 2:3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0021 affected19 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	HARTS 2.3	Non-systematic Assessment	EG0000 affected16 at risk EG0010 affected6 at risk EG0020 affected19 at risk EG003

The 40 patients in the NAb frequency summaries are the total number of patients with NAb titers at week 234. Official HARTS-to-MedDRA Mapping was used.

Certain Agreements

ID	Term
D020529	Multiple Sclerosis, Relapsing-Remitting

Ancestor Terms

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D000068576	Interferon beta-1b

Ancestor Terms

ID	Term
D016899	Interferon-beta
D007370	Interferon Type I
D007372	Interferons
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors