Atacicept in Subjects With Optic Neuritis | NCT00624468

Name	Class
Merck KGaA, Darmstadt, Germany	INDUSTRY

Label	Type	Description	Intervention Names
Atacicept	Experimental		Drug: Atacicept
Placebo	Placebo Comparator		Drug: Placebo matched to atacicept

Name	Type	Description	Arm Group Labels	Other Names
Atacicept	Drug	Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.

Measure	Description	Time Frame
Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)	The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and were then averaged over 12 sectors. The change in RNFL thickness at LOV visit was calculated as RNFL thickness at LOV minus RNFL thickness at baseline.	Baseline, LOV (Week 48)

Measure	Description	Time Frame
Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye	The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and was then averaged over 12 sectors. Difference was calculated as RNFL thickness in affected eye minus RNFL thickness in fellow eye.	Weeks 12, 24 and 36

Name	Affiliation	Role
Medical Responsible	EMD Serono, an affiliate of MerckKGaA, Darmstadt, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama		United States
Research Site

ID	Title	Description
FG000	Placebo: Double-blind Period	Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
FG001	Atacicept: Double-blind Period

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

Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Last Observed Value (LOV)

The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and were then averaged over 12 sectors. The change in RNFL thickness at LOV visit was calculated as RNFL thickness at LOV minus RNFL thickness at baseline.

ITT population included all randomized participants. Here, "n" signifies those participants who were evaluable for the specified category.

Posted

Mean

Standard Deviation

micrometer

Baseline, LOV (Week 48)

ID	Title	Description
OG000	Placebo: Double-blind Period	Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
OG001	Atacicept: Double-blind Period	Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.

Units	Counts
Participants	OG00017 OG00117

Title

Denominators

Categories

Baseline (n = 17, 17)

Title	Measurements
	OG000103.893± 17.271 OG001104.170± 8.832

Change at LOV (n = 16, 15)

Title	Measurements
	OG000

Secondary

Difference in Retinal Nerve Fibre Layer (RNFL) Thickness Between the Affected Eye and Fellow Eye

The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by optical coherence tomography (OCT) measurements and was then averaged over 12 sectors. Difference was calculated as RNFL thickness in affected eye minus RNFL thickness in fellow eye.

ITT population included all randomized participants. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and "n" signifies those participants who were evaluable for the specified category.

Posted

Mean

Standard Error

micrometer

Weeks 12, 24 and 36

ID	Title	Description
OG000	Placebo: Double-blind Period	Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
OG001	Atacicept: Double-blind Period	Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Retinal Nerve Fiber Layer (RNFL) Thickness in the Affected Eye at Weeks 12 and 24

The RNFL thickness was measured for 12 sectors (every 30 degrees) per eye in triplicate by OCT measurements and was then averaged over 12 sectors. The change in RNFL thickness at Weeks 12 and 24 was calculated as RNFL thickness at Weeks 12 and 24 minus RNFL thickness at baseline, respectively.

Posted

Mean

Standard Deviation

micrometer

Baseline, Weeks 12 and 24

ID	Title	Description
OG000	Placebo: Double-blind Period	Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
OG001	Atacicept: Double-blind Period	Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.

Units	Counts

Secondary

Change From Baseline in Macular Thickness at 3 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36

The change in macular thickness at 3 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 3 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 3 mm in the affected eye at baseline, respectively.

ITT population included all randomized participants. Here, "n" signifies those participants who were evaluable for the specified category.

Posted

Mean

Standard Deviation

micrometer

Baseline, Weeks 12, 24 and 36

ID	Title	Description
OG000	Placebo: Double-blind Period	Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
OG001	Atacicept: Double-blind Period	Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Macular Thickness at 6 Millimeter (mm) Around Fovea in the Affected Eye at Weeks 12, 24 and 36

The change in macular thickness at 6 mm around fovea in the affected eye at Weeks 12, 24 and 36 was calculated as macular thickness at 6 mm in the affected eye at Weeks 12, 24 and 36 minus macular thickness at 6 mm in the affected eye at baseline, respectively.

ITT population included all randomized participants. Here, "n" signifies those participants who were evaluable for the specified category.

Posted

Mean

Standard Deviation

micrometer

Baseline, Weeks 12, 24 and 36

ID	Title	Description
OG000	Placebo: Double-blind Period	Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
OG001	Atacicept: Double-blind Period	Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Macular Volume in the Affected Eye at Weeks 12, 24 and 36

The change in macular volume in the affected eye at Weeks 12, 24 and 36 was calculated as macular volume in the affected eye at Weeks 12, 24 and 36 minus macular volume in the affected eye at baseline, respectively.

ITT population included all randomized participants. Here, "n" signifies those participants who were evaluable for the specified category.

Posted

Mean

Standard Deviation

cubic micrometer

Baseline, Weeks 12, 24 and 36

ID	Title	Description
OG000	Placebo: Double-blind Period	Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
OG001	Atacicept: Double-blind Period	Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.

Units	Counts
Participants

Secondary

Low-Contrast Letter Acuity: Total Number of Letters Correctly Identified

Low-contrast letter acuity was measured by using the Sloan Charts at 1.25 fraction (%) and 2.5%. Sloan letters are a set of optotypes used to test visual acuity. Total number of letters correctly identified in the affected and fellow eye were reported. The possible Sloan Chart range is 0 to 70. More the number of letters identified, better is the visual acuity.

Posted

Mean

Standard Deviation

letters

Weeks 12, 24 and 36

ID	Title	Description
OG000	Placebo: Double-blind Period	Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
OG001	Atacicept: Double-blind Period	Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.

Units	Counts

Secondary

Contrast Sensitivity: Total Number of Letters Correctly Identified

Contrast Sensitivity was measured using the Pelli-Robson Charts. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. Total number of letters correctly identified in the affected and fellow eye were reported. The total possible range is 0 to 48. More the number of letters identified, better is the contrast sensitivity.

Posted

Mean

Standard Deviation

letters

Weeks 12, 24 and 36

ID	Title	Description
OG000	Placebo: Double-blind Period	Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
OG001	Atacicept: Double-blind Period	Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.

Secondary

Contrast Sensitivity: Score Line

Contrast sensitivity was measured using the Pelli-Robson charts with letters arranged in groups of 3. Pelli-Robson chart is used for clinical measurement of contrast sensitivity and determines the contrast required to read large letters of a fixed size. The possible score line range is 0 (visual disability) to 16 (normal contrast sensitivity).

Posted

Mean

Standard Deviation

units on a scale

Weeks 12, 24 and 36

ID	Title	Description
OG000	Placebo: Double-blind Period	Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
OG001	Atacicept: Double-blind Period	Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.

Units	Counts

Secondary

Percentage of Participants Converting to Clinically Definite Multiple Sclerosis (CDMS) Second Clinical Attack

Conversion to CDMS was defined as experiencing a second clinical attack meeting all of the following criteria: (a) Neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both (i) Neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and (ii) Neurological abnormality lasting for at least 24 hours; (b) Absence of fever or known infection (fever with temperature [axillary, orally or intraauricularly] greater than 37.5 degree Celsius/99.5 degree Fahrenheit); (c) Objective neurological impairment, correlating with the participant's reported symptoms, defined as either (i) Increase in at least 1 of the functional systems of the Expanded Disability Status Score (EDSS), or (ii) Increase of the total EDSS score. EDSS assesses disability in 8 functional systems and total score ranges from 0 (normal) to 10 (death due to MS). Percentage of participants converting to CDMS (second clinical attack) was reported.

ITT population included all randomized participants.

Posted

Number

percentage of participants

From baseline (Study Day 1) up to Week 36

ID	Title	Description
OG000	Placebo: Double-blind Period	Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
OG001	Atacicept: Double-blind Period

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site reaction	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected17 at risk EG00111 affected17 at risk EG0021 affected13 at risk EG0032 affected14 at risk
Fatigue	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected17 at risk EG0013 affected17 at risk EG0020 affected13 at risk EG003
Injection site haematoma	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0013 affected17 at risk EG0020 affected13 at risk EG003
Injection site erythema	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0012 affected17 at risk EG0020 affected13 at risk EG003
Injection site pain	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected17 at risk EG0020 affected13 at risk EG003
Asthenia	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Pyrexia	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Chest discomfort	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Injection site pruritus	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Injection site swelling	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Pain	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Influenza like illness	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0023 affected13 at risk EG003
Chest pain	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Headache	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected17 at risk EG0014 affected17 at risk EG0020 affected13 at risk EG003
Dizziness	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0004 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Balance disorder	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Muscle contractions involuntary	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Migraine	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Optic neuritis	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Syncope	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0003 affected17 at risk EG0012 affected17 at risk EG0020 affected13 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected17 at risk EG0020 affected13 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Tongue disorder	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Aerophagia	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Faecal incontinence	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Vomiting in pregnancy	Gastrointestinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0012 affected17 at risk EG0020 affected13 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected17 at risk EG0011 affected17 at risk EG0021 affected13 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0002 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Influenza	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected17 at risk EG0020 affected13 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Sinusitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Cystitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Rash pustular	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Ear infection	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Syphilis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Viral pharyngitis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Depression	Psychiatric disorders	MedDRA (13.0)	Non-systematic Assessment	EG0004 affected17 at risk EG0012 affected17 at risk EG0020 affected13 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0012 affected17 at risk EG0020 affected13 at risk EG003
Tracheal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0022 affected13 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Eye pain	Eye disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0012 affected17 at risk EG0020 affected13 at risk EG003
Asthenopia	Eye disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Uhthoff's phenomenon	Eye disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Visual acuity reduced	Eye disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Photopsia	Eye disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Vitreous floaters	Eye disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Liver function test abnormal	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Weight increased	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Blood glucose increased	Investigations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Pruritus allergic	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Bundle branch block right	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0011 affected17 at risk EG0020 affected13 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Galactorrhoea	Reproductive system and breast disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Bone fissure	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Anaemia of pregnancy	Blood and lymphatic system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Hypotension	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0001 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Hypertension	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Stress urinary incontinence	Renal and urinary disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Food allergy	Immune system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003

ID	Term
D009901	Optic Nerve Diseases
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

ID	Title	Description
BG000	Placebo: Double-blind Period	Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.
BG001	Atacicept: Double-blind Period	Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo: Double-blind Period	Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.	0	17	14	17
EG001	Atacicept: Double-blind Period	Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.	0	17	16	17
EG002	Placebo: SFU Period	Participants who received placebo matched to atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.	1	13	6	13
EG003	Atacicept: SFU Period	Participants who received atacicept in double-blind period were included in SFU period (60 weeks) following premature termination of the trial.	2	14	10	14

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bacterial pyelonephritis	Infections and infestations	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG0031 affected14 at risk
Multiple sclerosis	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Myelitis transverse	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0020 affected13 at risk EG003
Myelitis	Nervous system disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Pyrexia	General disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA (13.0)	Non-systematic Assessment	EG0000 affected17 at risk EG0010 affected17 at risk EG0021 affected13 at risk EG003