Assessment Study of Steroid Effect in Relapsing Multiple Sclerosis Subjects Treated With Glatiramer Acetate (ASSERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00203047

Recruitment Status : Terminated (Slow enrollment decreased sample size; No unexpected safety issues.)

First Posted : September 20, 2005

Results First Posted : January 6, 2014

Last Update Posted : January 6, 2014

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Teva Branded Pharmaceutical Products R&D, Inc.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Relapsing Remitting Multiple Sclerosis
Interventions	Drug: Glatiramer Acetate Drug: Placebo Drug: Prednisone
Enrollment	414

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	GA + Placebo	GA + Prednisone
Arm/Group Description	Glatiramer acetate (GA) 10mg as a s...	Glatiramer acetate (GA) 20mg daily ...
Arm/Group Description	Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.	Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
Period Title: Overall Study
Started	204	210
In Database as of January 29, 2009	199	209
Completed	13	7
Not Completed	191	203
Reason Not Completed
Ongoing: in database - January 29, 2009	131	109
Ongoing: not in database - Jan 29, 2009	5	1
Withdrawal by Subject	13	47
Teva requested participant withdrawal	1	1
Physician Decision	8	7
Non-compliance	4	8
Protocol Violation	1	0
Lost to Follow-up	11	5
Adverse Event	8	18
Death	1	2
Pregnancy	3	0
Other	5	5

Baseline Characteristics

Arm/Group Title		GA + Placebo	GA + Prednisone	Total
Arm/Group Description		Glatiramer acetate (GA) 10mg as a s...	Glatiramer acetate (GA) 20mg daily ...	Total of all reporting groups
Arm/Group Description		Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.	Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.	Total of all reporting groups
Overall Number of Baseline Participants		199	209	408
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Represents database as of January 29, 2009
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	199 participants	209 participants	408 participants
<=29 years		32	40	72
=30 and < 40 years		61	68	129
=40 and < 50 years		70	70	140
=50 and < 55 years		35	29	64
>= 55 years		1	2	3
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	199 participants	209 participants	408 participants
	Female	151 75.9%	157 75.1%	308 75.5%
	Male	48 24.1%	52 24.9%	100 24.5%
Race/Ethnicity, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	199 participants	209 participants	408 participants
Hispanic		10	9	19
Asian / Oriental		1	0	1
Black of African Heritage		13	15	28
Caucasian		171	179	350
Other		4	6	10
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	199 participants	209 participants	408 participants
Australia		4	1	5
Canada		16	20	36
United States		179	188	367
Time from First Multiple Sclerosis (MS) Symptom Mean (Standard Deviation) Unit of measure: Months
	Number Analyzed	199 participants	209 participants	408 participants
		89.8 (104.5)	76.7 (75.5)	83.1 (91.0)
Time from MS Diagnosis Mean (Standard Deviation) Unit of measure: Months
	Number Analyzed	199 participants	209 participants	408 participants
		40.5 (71.4)	42.1 (62.9)	41.3 (67.1)
T1 Enhancing Lesions at Baseline ^[1] Mean (Standard Deviation) Unit of measure: Lesions
	Number Analyzed	199 participants	209 participants	408 participants
		1.05 (2.77)	1.86 (9.91)	1.43 (7.12)
		[1] Measure Description: Enhancing lesions represent new lesions due to recent disease activity and may indicate a relapse. 171 GA + Placebo and 155 GA + Prednisone participants had baseline MRI data in the database as of January 29, 2009.
T1 Hypointense Lesions Volume at Baseline ^[1] Mean (Standard Deviation) Unit of measure: Cm^3
	Number Analyzed	199 participants	209 participants	408 participants
		0.94 (1.77)	0.84 (1.50)	0.89 (1.64)
		[1] Measure Description: Hypointense lesions display as dark areas on the MRI image, and represent areas of permanent axonal damage. 171 GA + Placebo and 155 GA + Prednisone participants had baseline MRI data in the database as of January 29, 2009.
T2 Lesions Volume at Baseline ^[1] Mean (Standard Deviation) Unit of measure: Cm^3
	Number Analyzed	199 participants	209 participants	408 participants
		5.51 (7.17)	5.35 (7.97)	5.44 (7.55)
		[1] Measure Description: T2 lesions are hyperintense lesions meaning that they appear as bright spots on the MRI image. These tend to show the total number of lesions and disease burden. 171 GA + Placebo and 155 GA + Prednisone participants had baseline MRI data in the database as of January 29, 2009.

Outcome Measures

1.Primary Outcome


Title	Percent Change From Baseline to Termination in Normalized Brain Volume Measured According to the SIENA (Structural Imaging Evaluation Using Normalization of Atrophy) Method
Description	Results represent the database as of January 29, 2009. Brain volume wa...
Description	Results represent the database as of January 29, 2009. Brain volume was measured at baseline and at months 24, 36 and at early termination visits by magnetic resonance imaging (MRI). Brain atrophy was measured by comparing the change in brain volume from baseline to the latest scan at the three during study timeframes. SIENA is a fully automated method of analyzing longitudinal brain change. Adjusted (least square) mean values are presented.
Time Frame	Day 0, latest scan at month 24, 36 or early termination visit

Outcome Measure Data

Analysis Population Description

Treated population of participants who had both a baseline MRI and an MRI at least one of the three during study time frames. The latest MRI was used if more than one during study MRI was available.


Arm/Group Title	GA + Placebo	GA + Prednisone
Arm/Group Description:	Glatiramer acetate (GA) 10mg as a s...	Glatiramer acetate (GA) 20mg daily ...
Arm/Group Description:	Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.	Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
Overall Number of Participants Analyzed	105	84
Least Squares Mean (Standard Error) Unit of Measure: percent change of baseline brain volume
	-0.46 (0.088)	-0.43 (0.106)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GA + Placebo, GA + Prednisone
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.8023
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95% -0.26 to 0.20
	Parameter Dispersion	Type: Standard Error of the mean Value: 0.11820976
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Cumulative Number of Enhancing Lesions at Months 12, 24 and 36
Description	Results represent the database as of January 29, 2009. ...
Description	Results represent the database as of January 29, 2009. Enhancing lesions are lesions that show inflammation on an MRI and are assumed to be new lesions. The sum of enhancing lesions observed in MRIs taken at months 12, 24 and 36 are offered.
Time Frame	Months 12, 24, and 36

Outcome Measure Data

Analysis Population Description

Treated population who had at least a 12 month MRI


Arm/Group Title	GA + Placebo	GA + Prednisone
Arm/Group Description:	Glatiramer acetate (GA) 10mg as a s...	Glatiramer acetate (GA) 20mg daily ...
Arm/Group Description:	Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.	Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
Overall Number of Participants Analyzed	155	143
Mean (Standard Deviation) Unit of Measure: lesions
	0.69 (3.28)	0.76 (1.86)

3.Secondary Outcome


Title	Change From Baseline to Month 36 or Early Termination Visit in Volume of T2-Lesions
Description	Results represent the database as of January 29, 2009. ...
Description	Results represent the database as of January 29, 2009. The difference in T2 brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. T2 lesions are hyperintense lesions meaning that they appear as bright spots on the MRI image. These tend to show the total number of lesions and disease burden.
Time Frame	Day 0, Month 36 or the early termination visit

Outcome Measure Data

Analysis Population Description

Treated population of participants with an MRI at the stated time frames.


Arm/Group Title	GA + Placebo	GA + Prednisone
Arm/Group Description:	Glatiramer acetate (GA) 10mg as a s...	Glatiramer acetate (GA) 20mg daily ...
Arm/Group Description:	Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.	Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
Overall Number of Participants Analyzed	58	51
Mean (Standard Deviation) Unit of Measure: cm^3
	0.07 (3.21)	0.09 (2.93)

4.Secondary Outcome


Title	Change From Baseline to Month 36 or Early Termination Visit in Volume of Hypointense Lesions
Description	Results represent the database as of January 29, 2009. ...
Description	Results represent the database as of January 29, 2009. The difference in hypointense brain lesion volume as observed in MRIs from baseline to Month 36 or the early termination visit. Hypointense lesions display as dark areas on the MRI image, and represent areas of permanent axonal damage.
Time Frame	Day 0, Month 36 or early termination visit

Outcome Measure Data

Analysis Population Description

Treated population of participants with an MRI at the stated time frames.


Arm/Group Title	GA + Placebo	GA + Prednisone
Arm/Group Description:	Glatiramer acetate (GA) 10mg as a s...	Glatiramer acetate (GA) 20mg daily ...
Arm/Group Description:	Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.	Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
Overall Number of Participants Analyzed	58	51
Mean (Standard Deviation) Unit of Measure: cm^3
	0.43 (1.60)	0.17 (0.86)

Adverse Events

Time Frame	Day 1 through month 36
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	GA + Placebo	GA + Prednisone
Arm/Group Description	Glatiramer acetate (GA) 10mg as a s...	Glatiramer acetate (GA) 20mg daily ...
Arm/Group Description	Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.	Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
All-Cause Mortality
	GA + Placebo	GA + Prednisone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	GA + Placebo	GA + Prednisone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	16/199 (8.04%)	13/209 (6.22%)
Cardiac disorders
Myocardial infarction ^† 1	1/199 (0.50%)	0/209 (0.00%)
Pericarditis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Ear and labyrinth disorders
Vertigo ^† 1	0/199 (0.00%)	1/209 (0.48%)
Endocrine disorders
Autoimmune thyroiditis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Eye disorders
Blindness ^† 1	1/199 (0.50%)	1/209 (0.48%)
Gastrointestinal disorders
Constipation ^† 1	0/199 (0.00%)	1/209 (0.48%)
Nausea ^† 1	0/199 (0.00%)	1/209 (0.48%)
Vomiting ^† 1	0/199 (0.00%)	1/209 (0.48%)
General disorders
Death ^† 1	0/199 (0.00%)	1/209 (0.48%)
Pyrexia ^† 1	0/199 (0.00%)	2/209 (0.96%)
Chest pain ^† 1	1/199 (0.50%)	1/209 (0.48%)
Hepatobiliary disorders
Cholecystitis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Immune system disorders
Anaphylactic reaction ^† 1	0/199 (0.00%)	1/209 (0.48%)
Infections and infestations
Cellulitis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Mastoiditis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Otitis media ^† 1	1/199 (0.50%)	0/209 (0.00%)
Influenza ^† 1	0/199 (0.00%)	1/209 (0.48%)
Urosepsis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Staphylococcal infection ^† 1	1/199 (0.50%)	0/209 (0.00%)
Urinary tract infection ^† 1	0/199 (0.00%)	1/209 (0.48%)
Injury, poisoning and procedural complications
Brain contusion ^† 1	1/199 (0.50%)	0/209 (0.00%)
Closed head injury ^† 1	0/199 (0.00%)	1/209 (0.48%)
Subdural haematoma ^† 1	1/199 (0.50%)	0/209 (0.00%)
Drug toxicity ^† 1	0/199 (0.00%)	1/209 (0.48%)
Investigations
Heart rate increased ^† 1	0/199 (0.00%)	1/209 (0.48%)
Metabolism and nutrition disorders
Dehydration ^† 1	0/199 (0.00%)	2/209 (0.96%)
Musculoskeletal and connective tissue disorders
Muscle twitching ^† 1	0/199 (0.00%)	1/209 (0.48%)
Muscular weakness ^† 1	0/199 (0.00%)	1/209 (0.48%)
Musculoskeletal chest pain ^† 1	0/199 (0.00%)	1/209 (0.48%)
Pain in extremity ^† 1	1/199 (0.50%)	0/209 (0.00%)
Sensation of heaviness ^† 1	0/199 (0.00%)	1/209 (0.48%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer ^† 1	1/199 (0.50%)	0/209 (0.00%)
Breast cancer in situ ^† 1	1/199 (0.50%)	0/209 (0.00%)
Lymphoma ^† 1	1/199 (0.50%)	0/209 (0.00%)
Nervous system disorders
Aphasia ^† 1	1/199 (0.50%)	0/209 (0.00%)
Syncope ^† 1	0/199 (0.00%)	1/209 (0.48%)
Grand mal convulsion ^† 1	1/199 (0.50%)	0/209 (0.00%)
Headache ^† 1	0/199 (0.00%)	2/209 (0.96%)
Multiple sclerosis ^† 1	2/199 (1.01%)	0/209 (0.00%)
Hypoaesthesia ^† 1	0/199 (0.00%)	1/209 (0.48%)
Convulsion ^† 1	0/199 (0.00%)	1/209 (0.48%)
Dysarthria ^† 1	0/199 (0.00%)	1/209 (0.48%)
Tremor ^† 1	0/199 (0.00%)	1/209 (0.48%)
Psychiatric disorders
Suicidal ideation ^† 1	1/199 (0.50%)	1/209 (0.48%)
Renal and urinary disorders
Nephrolithiasis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	0/199 (0.00%)	1/209 (0.48%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (9.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	GA + Placebo	GA + Prednisone
	Affected / at Risk (%)	Affected / at Risk (%)
Total	131/199 (65.83%)	151/209 (72.25%)
Blood and lymphatic system disorders
Iron deficiency anaemia ^† 1	1/199 (0.50%)	0/209 (0.00%)
Anaemia ^† 1	2/199 (1.01%)	1/209 (0.48%)
Lymphadenopathy ^† 1	1/199 (0.50%)	0/209 (0.00%)
Cardiac disorders
Palpitations ^† 1	1/199 (0.50%)	5/209 (2.39%)
Tachycardia ^† 1	0/199 (0.00%)	6/209 (2.87%)
Arrhythmia supraventricular ^† 1	0/199 (0.00%)	1/209 (0.48%)
Congenital, familial and genetic disorders
Colour blindness ^† 1	0/199 (0.00%)	1/209 (0.48%)
Ear and labyrinth disorders
Ear pain ^† 1	0/199 (0.00%)	1/209 (0.48%)
Hearing impaired ^† 1	0/199 (0.00%)	1/209 (0.48%)
Vestibular disorder ^† 1	1/199 (0.50%)	0/209 (0.00%)
Motion sickness ^† 1	0/199 (0.00%)	1/209 (0.48%)
Tinnitis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Vertigo ^† 1	2/199 (1.01%)	2/209 (0.96%)
Vertigo positional ^† 1	1/199 (0.50%)	0/209 (0.00%)
Tympanic membrane perforation ^† 1	0/199 (0.00%)	1/209 (0.48%)
Endocrine disorders
Hyperparathyroidism ^† 1	0/199 (0.00%)	1/209 (0.48%)
Goitre ^† 1	0/199 (0.00%)	1/209 (0.48%)
Thyroid disorder ^† 1	0/199 (0.00%)	1/209 (0.48%)
Hyperthyroidism ^† 1	1/199 (0.50%)	0/209 (0.00%)
Hypothyroidism ^† 1	1/199 (0.50%)	0/209 (0.00%)
Eye disorders
Blindness ^† 1	1/199 (0.50%)	0/209 (0.00%)
Cataract ^† 1	1/199 (0.50%)	1/209 (0.48%)
Conjunctivitis ^† 1	0/199 (0.00%)	2/209 (0.96%)
Dry eye ^† 1	2/199 (1.01%)	1/209 (0.48%)
Lacrimation increased ^† 1	1/199 (0.50%)	1/209 (0.48%)
Madarosis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Eye pain ^† 1	0/199 (0.00%)	4/209 (1.91%)
Eye allergy ^† 1	0/199 (0.00%)	1/209 (0.48%)
Eye irritation ^† 1	1/199 (0.50%)	0/209 (0.00%)
Ocular hyperaemia ^† 1	2/199 (1.01%)	0/209 (0.00%)
Asthenopia ^† 1	1/199 (0.50%)	0/209 (0.00%)
Optic atrophy ^† 1	1/199 (0.50%)	0/209 (0.00%)
Visual acuity reduced ^† 1	0/199 (0.00%)	1/209 (0.48%)
Pupillary reflex impaired ^† 1	0/199 (0.00%)	1/209 (0.48%)
Macular cyst ^† 1	1/199 (0.50%)	0/209 (0.00%)
Diplopia ^† 1	0/199 (0.00%)	1/209 (0.48%)
Vision blurred ^† 1	1/199 (0.50%)	9/209 (4.31%)
Visual disturbance ^† 1	0/199 (0.00%)	3/209 (1.44%)
Gastrointestinal disorders
Abdominal hernia ^† 1	2/199 (1.01%)	0/209 (0.00%)
Toothache ^† 1	2/199 (1.01%)	3/209 (1.44%)
Hiatus hernia ^† 1	1/199 (0.50%)	0/209 (0.00%)
Diarrhoea ^† 1	8/199 (4.02%)	14/209 (6.70%)
Dyspepsia ^† 1	5/199 (2.51%)	16/209 (7.66%)
Epigastic discomfort ^† 1	0/199 (0.00%)	2/209 (0.96%)
Eructation ^† 1	0/199 (0.00%)	1/209 (0.48%)
Abdominal distension ^† 1	0/199 (0.00%)	2/209 (0.96%)
Flatulence ^† 1	0/199 (0.00%)	1/209 (0.48%)
Gastritis ^† 1	2/199 (1.01%)	5/209 (2.39%)
Abdominal pain ^† 1	3/199 (1.51%)	5/209 (2.39%)
Abdominal pain upper ^† 1	2/199 (1.01%)	7/209 (3.35%)
Constipation ^† 1	1/199 (0.50%)	3/209 (1.44%)
Gastrooesophageal reflux disease ^† 1	2/199 (1.01%)	6/209 (2.87%)
Enteritis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Abdominal discomfort ^† 1	1/199 (0.50%)	2/209 (0.96%)
Breath odour ^† 1	0/199 (0.00%)	1/209 (0.48%)
Dysphagia ^† 1	2/199 (1.01%)	3/209 (1.44%)
Faecal incontinence ^† 1	1/199 (0.50%)	0/209 (0.00%)
Stomach discomfort ^† 1	0/199 (0.00%)	1/209 (0.48%)
Gingivitis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Haemorrhoids ^† 1	1/199 (0.50%)	2/209 (0.96%)
Nausea ^† 1	15/199 (7.54%)	15/209 (7.18%)
Vomiting ^† 1	6/199 (3.02%)	7/209 (3.35%)
Haematochezia ^† 1	1/199 (0.50%)	0/209 (0.00%)
Reflux oesophagitis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Dry mouth ^† 1	0/199 (0.00%)	2/209 (0.96%)
Hypoaesthesia oral ^† 1	2/199 (1.01%)	0/209 (0.00%)
Peritoneal lesion ^† 1	0/199 (0.00%)	1/209 (0.48%)
Mouth ulceration ^† 1	0/199 (0.00%)	1/209 (0.48%)
Stomatitis ^† 1	1/199 (0.50%)	1/209 (0.48%)
General disorders
Administration site reaction ^† 1	0/199 (0.00%)	1/209 (0.48%)
Asthenia ^† 1	1/199 (0.50%)	1/209 (0.48%)
Fatigue ^† 1	13/199 (6.53%)	21/209 (10.05%)
Malaise ^† 1	0/199 (0.00%)	6/209 (2.87%)
Chills ^† 1	1/199 (0.50%)	5/209 (2.39%)
Peripheral coldness ^† 1	1/199 (0.50%)	0/209 (0.00%)
Pyrexia ^† 1	6/199 (3.02%)	5/209 (2.39%)
Gait disturbance ^† 1	0/199 (0.00%)	2/209 (0.96%)
Chest discomfort ^† 1	3/199 (1.51%)	5/209 (2.39%)
Energy increased ^† 1	0/199 (0.00%)	1/209 (0.48%)
Feeling abnormal ^† 1	0/199 (0.00%)	1/209 (0.48%)
Feeling jittery ^† 1	1/199 (0.50%)	3/209 (1.44%)
Flushing ^† 1	1/199 (0.50%)	1/209 (0.48%)
Hangover ^† 1	0/199 (0.00%)	1/209 (0.48%)
Influenza like illness ^† 1	0/199 (0.00%)	3/209 (1.44%)
Irritability ^† 1	0/199 (0.00%)	2/209 (0.96%)
Swelling ^† 1	0/199 (0.00%)	2/209 (0.96%)
Thirst ^† 1	0/199 (0.00%)	1/209 (0.48%)
Inflammation ^† 1	2/199 (1.01%)	0/209 (0.00%)
Infusion site reaction ^† 1	1/199 (0.50%)	0/209 (0.00%)
Injection site bruising ^† 1	1/199 (0.50%)	3/209 (1.44%)
Injection site erythema ^† 1	9/199 (4.52%)	3/209 (1.44%)
Injection site haemorrhage ^† 1	0/199 (0.00%)	1/209 (0.48%)
Injection site induration ^† 1	3/199 (1.51%)	1/209 (0.48%)
Injection site mass ^† 1	1/199 (0.50%)	0/209 (0.00%)
Injection site nodule ^† 1	1/199 (0.50%)	0/209 (0.00%)
Injection site pain ^† 1	3/199 (1.51%)	6/209 (2.87%)
Injection site pruritus ^† 1	5/199 (2.51%)	3/209 (1.44%)
Injection site reaction ^† 1	8/199 (4.02%)	8/209 (3.83%)
Injection site swelling ^† 1	2/199 (1.01%)	0/209 (0.00%)
Injection site urticaria ^† 1	1/199 (0.50%)	0/209 (0.00%)
Cyst ^† 1	1/199 (0.50%)	0/209 (0.00%)
Face oedema ^† 1	0/199 (0.00%)	4/209 (1.91%)
Generalised oedema ^† 1	0/199 (0.00%)	1/209 (0.48%)
Oedema ^† 1	0/199 (0.00%)	4/209 (1.91%)
Oedema peripheral ^† 1	3/199 (1.51%)	5/209 (2.39%)
Chest pain ^† 1	0/199 (0.00%)	5/209 (2.39%)
Non-cardiac chest pain ^† 1	0/199 (0.00%)	1/209 (0.48%)
Pain ^† 1	2/199 (1.01%)	12/209 (5.74%)
Adverse drug reaction ^† 1	1/199 (0.50%)	2/209 (0.96%)
Idiosyncratic drug reaction ^† 1	0/199 (0.00%)	1/209 (0.48%)
Hepatobiliary disorders
Cholelithiasis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Hepatic cirrhosis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Hepatic steatosis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Immune system disorders
Allergy to animal ^† 1	0/199 (0.00%)	1/209 (0.48%)
Hypersensitivity ^† 1	1/199 (0.50%)	1/209 (0.48%)
Drug hypersensitivity ^† 1	1/199 (0.50%)	3/209 (1.44%)
Food allergy ^† 1	1/199 (0.50%)	1/209 (0.48%)
Seasonal allergy ^† 1	0/199 (0.00%)	3/209 (1.44%)
Infections and infestations
Gastric infection ^† 1	0/199 (0.00%)	1/209 (0.48%)
Gastroenteritis ^† 1	2/199 (1.01%)	1/209 (0.48%)
Bacteriuria ^† 1	1/199 (0.50%)	0/209 (0.00%)
Cellulitis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Vaginitis bacterial ^† 1	2/199 (1.01%)	0/209 (0.00%)
Candidiasis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Oral candidiasis ^† 1	2/199 (1.01%)	3/209 (1.44%)
Coxsackie viral infection ^† 1	0/199 (0.00%)	1/209 (0.48%)
Tooth abscess ^† 1	3/199 (1.51%)	3/209 (1.44%)
Tooth infection ^† 1	2/199 (1.01%)	2/209 (0.96%)
Ear infection ^† 1	1/199 (0.50%)	0/209 (0.00%)
Otitis externa ^† 1	0/199 (0.00%)	1/209 (0.48%)
Otitis media ^† 1	1/199 (0.50%)	1/209 (0.48%)
Conjunctivitis infective ^† 1	2/199 (1.01%)	0/209 (0.00%)
Eye infection ^† 1	4/199 (2.01%)	2/209 (0.96%)
Vaginal infection ^† 1	0/199 (0.00%)	2/209 (0.96%)
Fungal infection ^† 1	2/199 (1.01%)	3/209 (1.44%)
Onychomycosis ^† 1	2/199 (1.01%)	0/209 (0.00%)
Oral fungal infection ^† 1	0/199 (0.00%)	1/209 (0.48%)
Vulvovaginal mycotic infection ^† 1	0/199 (0.00%)	4/209 (1.91%)
Herpes simplex ^† 1	3/199 (1.51%)	2/209 (0.96%)
Herpes simplex ophthalmic ^† 1	1/199 (0.50%)	0/209 (0.00%)
Herpes virus infection ^† 1	0/199 (0.00%)	1/209 (0.48%)
Herpes zoster ^† 1	1/199 (0.50%)	1/209 (0.48%)
Localised infection ^† 1	1/199 (0.50%)	0/209 (0.00%)
Influenza ^† 1	5/199 (2.51%)	6/209 (2.87%)
Bronchitis ^† 1	13/199 (6.53%)	5/209 (2.39%)
Bronchitis acute ^† 1	1/199 (0.50%)	2/209 (0.96%)
Bronchitis chronic ^† 1	0/199 (0.00%)	1/209 (0.48%)
Lower respiratory tract infection ^† 1	2/199 (1.01%)	0/209 (0.00%)
Pneumonia ^† 1	0/199 (0.00%)	1/209 (0.48%)
Mycoplasma infection ^† 1	1/199 (0.50%)	0/209 (0.00%)
Eczema infected ^† 1	1/199 (0.50%)	0/209 (0.00%)
Skin infection ^† 1	1/199 (0.50%)	0/209 (0.00%)
Staphylococcal infection ^† 1	0/199 (0.00%)	4/209 (1.91%)
Pharyngitis streptococcal ^† 1	2/199 (1.01%)	1/209 (0.48%)
Tinea infection ^† 1	0/199 (0.00%)	1/209 (0.48%)
Acute sinusitis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Chronic sinusitis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Nasopharyngitis ^† 1	19/199 (9.55%)	22/209 (10.53%)
Pharyngitis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Sinusitis ^† 1	10/199 (5.03%)	16/209 (7.66%)
Upper respiratory tract infection ^† 1	12/199 (6.03%)	25/209 (11.96%)
Cystitis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Pyelonephritis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Urinary tract infection ^† 1	15/199 (7.54%)	23/209 (11.00%)
Bronchitis viral ^† 1	1/199 (0.50%)	1/209 (0.48%)
Gastroenteritis viral ^† 1	3/199 (1.51%)	3/209 (1.44%)
Viral pharyngitis ^† 1	0/199 (0.00%)	2/209 (0.96%)
Viral sinusitis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Injury, poisoning and procedural complications
Caustic injury ^† 1	0/199 (0.00%)	1/209 (0.48%)
Joint dislocation ^† 1	0/199 (0.00%)	1/209 (0.48%)
Injection site reaction ^† 1	1/199 (0.50%)	0/209 (0.00%)
Injection site urticaria ^† 1	1/199 (0.50%)	0/209 (0.00%)
Joint injury ^† 1	0/199 (0.00%)	1/209 (0.48%)
Joint sprain ^† 1	1/199 (0.50%)	5/209 (2.39%)
Rotator cuff syndrome ^† 1	0/199 (0.00%)	1/209 (0.48%)
Ankle fracture ^† 1	1/199 (0.50%)	0/209 (0.00%)
Foot fracture ^† 1	1/199 (0.50%)	2/209 (0.96%)
Muscle strain ^† 1	1/199 (0.50%)	2/209 (0.96%)
Arthropod bite ^† 1	0/199 (0.00%)	1/209 (0.48%)
Excoriation ^† 1	0/199 (0.00%)	1/209 (0.48%)
Fall ^† 1	2/199 (1.01%)	7/209 (3.35%)
Accidental needle stick ^† 1	1/199 (0.50%)	0/209 (0.00%)
Procedural pain ^† 1	2/199 (1.01%)	0/209 (0.00%)
Back injury ^† 1	0/199 (0.00%)	1/209 (0.48%)
Head injury ^† 1	0/199 (0.00%)	1/209 (0.48%)
Tooth fracture ^† 1	1/199 (0.50%)	1/209 (0.48%)
Contusion ^† 1	3/199 (1.51%)	1/209 (0.48%)
Skin laceration ^† 1	0/199 (0.00%)	2/209 (0.96%)
Rib fracture ^† 1	0/199 (0.00%)	1/209 (0.48%)
Humerus fracture ^† 1	1/199 (0.50%)	0/209 (0.00%)
Ulna fracture ^† 1	1/199 (0.50%)	0/209 (0.00%)
Investigations
Blood glucose increased ^† 1	1/199 (0.50%)	2/209 (0.96%)
Cardiac murmur ^† 1	1/199 (0.50%)	0/209 (0.00%)
Blood cholesterol increased ^† 1	4/199 (2.01%)	3/209 (1.44%)
Heart rate decreased ^† 1	0/199 (0.00%)	1/209 (0.48%)
Heart rate increased ^† 1	0/199 (0.00%)	1/209 (0.48%)
Alanine aminotransferase increased ^† 1	1/199 (0.50%)	0/209 (0.00%)
Blood uric acid increased ^† 1	1/199 (0.50%)	0/209 (0.00%)
Urine ketone body present ^† 1	1/199 (0.50%)	0/209 (0.00%)
Blood potassium increased ^† 1	1/199 (0.50%)	0/209 (0.00%)
Body temperature fluctuations ^† 1	1/199 (0.50%)	0/209 (0.00%)
Breath sounds abnormal ^† 1	1/199 (0.50%)	0/209 (0.00%)
Weight increased ^† 1	3/199 (1.51%)	7/209 (3.35%)
Blood thyroid stimulating hormone decreased ^† 1	1/199 (0.50%)	1/209 (0.48%)
Blood thyroid stimulating hormone increased ^† 1	0/199 (0.00%)	2/209 (0.96%)
Protein total increased ^† 1	1/199 (0.50%)	0/209 (0.00%)
Blood testosterone decreased ^† 1	1/199 (0.50%)	0/209 (0.00%)
Blood triglycerides increased ^† 1	0/199 (0.00%)	1/209 (0.48%)
Protein urine ^† 1	1/199 (0.50%)	0/209 (0.00%)
Urine analysis abnormal ^† 1	0/199 (0.00%)	1/209 (0.48%)
Urine leukocyte esterase positive ^† 1	1/199 (0.50%)	0/209 (0.00%)
White blood cells urine positive ^† 1	1/199 (0.50%)	1/209 (0.48%)
Blood pressure increased ^† 1	0/199 (0.00%)	1/209 (0.48%)
Herpes simplex serology positive ^† 1	1/199 (0.50%)	0/209 (0.00%)
Vitamin D decreased ^† 1	0/199 (0.00%)	1/209 (0.48%)
White blood cell count increased ^† 1	1/199 (0.50%)	1/209 (0.48%)
Metabolism and nutrition disorders
Anorexia ^† 1	0/199 (0.00%)	1/209 (0.48%)
Appetite disorder ^† 1	0/199 (0.00%)	1/209 (0.48%)
Decreased appetite ^† 1	1/199 (0.50%)	3/209 (1.44%)
Increased appetite ^† 1	1/199 (0.50%)	2/209 (0.96%)
Hypercalcaemia ^† 1	0/199 (0.00%)	1/209 (0.48%)
Diabetes mellitus ^† 1	0/199 (0.00%)	1/209 (0.48%)
Diabetes mellitus non-insulin-dependent ^† 1	0/199 (0.00%)	1/209 (0.48%)
Hypercholesterolaemia ^† 1	2/199 (1.01%)	2/209 (0.96%)
Vitamin D deficiency ^† 1	1/199 (0.50%)	4/209 (1.91%)
Hyperglycaemia ^† 1	1/199 (0.50%)	1/209 (0.48%)
Hyperlipidaemia ^† 1	0/199 (0.00%)	1/209 (0.48%)
Dyslipidaemia ^† 1	0/199 (0.00%)	1/209 (0.48%)
Hypokalaemia ^† 1	1/199 (0.50%)	0/209 (0.00%)
Gout ^† 1	1/199 (0.50%)	1/209 (0.48%)
Fluid retention ^† 1	0/199 (0.00%)	6/209 (2.87%)
Oedema ^† 1	0/199 (0.00%)	1/209 (0.48%)
Musculoskeletal and connective tissue disorders
Arthritis ^† 1	1/199 (0.50%)	1/209 (0.48%)
Bone cyst ^† 1	0/199 (0.00%)	1/209 (0.48%)
Osteonecrosis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Bone pain ^† 1	1/199 (0.50%)	2/209 (0.96%)
Pain in jaw ^† 1	0/199 (0.00%)	1/209 (0.48%)
Intervertebral disc protrusion ^† 1	0/199 (0.00%)	1/209 (0.48%)
Joint contracture ^† 1	1/199 (0.50%)	0/209 (0.00%)
Periarthritis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Arthralgia ^† 1	8/199 (4.02%)	11/209 (5.26%)
Joint stiffness ^† 1	0/199 (0.00%)	2/209 (0.96%)
Joint swelling ^† 1	0/199 (0.00%)	2/209 (0.96%)
Loose body in joint ^† 1	1/199 (0.50%)	0/209 (0.00%)
Plantar fasciitis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Osteopenia ^† 1	0/199 (0.00%)	4/209 (1.91%)
Osteoporosis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Myalgia ^† 1	2/199 (1.01%)	9/209 (4.31%)
Muscle spasms ^† 1	9/199 (4.52%)	9/209 (4.31%)
Muscle tightness ^† 1	0/199 (0.00%)	1/209 (0.48%)
Muscle twitching ^† 1	2/199 (1.01%)	0/209 (0.00%)
Myokymia ^† 1	0/199 (0.00%)	1/209 (0.48%)
Muscular weakness ^† 1	2/199 (1.01%)	6/209 (2.87%)
Back pain ^† 1	3/199 (1.51%)	4/209 (1.91%)
Dupuytren's contracture ^† 1	1/199 (0.50%)	0/209 (0.00%)
Musculoskeletal chest pain ^† 1	0/199 (0.00%)	2/209 (0.96%)
Musculoskeletal stiffness ^† 1	2/199 (1.01%)	1/209 (0.48%)
Neck pain ^† 1	4/199 (2.01%)	4/209 (1.91%)
Pain in extremity ^† 1	7/199 (3.52%)	11/209 (5.26%)
Shoulder pain ^† 1	2/199 (1.01%)	3/209 (1.44%)
Osteoarthritis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Axillary mass ^† 1	0/199 (0.00%)	1/209 (0.48%)
Groin pain ^† 1	0/199 (0.00%)	1/209 (0.48%)
Cervical spinal stenosis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Tendonitis ^† 1	1/199 (0.50%)	3/209 (1.44%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cyst ^† 1	0/199 (0.00%)	2/209 (0.96%)
Teratoma ^† 1	0/199 (0.00%)	1/209 (0.48%)
Lip neoplasm ^† 1	1/199 (0.50%)	0/209 (0.00%)
Abdominal neoplasm ^† 1	0/199 (0.00%)	1/209 (0.48%)
Ovarian cyst ^† 1	0/199 (0.00%)	1/209 (0.48%)
Uterine leiomyoma ^† 1	0/199 (0.00%)	1/209 (0.48%)
Nervous system disorders
Carotid artery aneurysm ^† 1	0/199 (0.00%)	1/209 (0.48%)
Balance disorder ^† 1	1/199 (0.50%)	4/209 (1.91%)
Coordination abnormal ^† 1	0/199 (0.00%)	2/209 (0.96%)
Nystagmus ^† 1	2/199 (1.01%)	1/209 (0.48%)
Lethargy ^† 1	1/199 (0.50%)	1/209 (0.48%)
Loss of consciousness ^† 1	2/199 (1.01%)	1/209 (0.48%)
Somnolence ^† 1	2/199 (1.01%)	1/209 (0.48%)
Syncope vasovagal ^† 1	0/199 (0.00%)	2/209 (0.96%)
Circadian rhythm sleep disorder ^† 1	1/199 (0.50%)	0/209 (0.00%)
Hyperkinesia ^† 1	0/199 (0.00%)	1/209 (0.48%)
Psychomotor hyperactivity ^† 1	1/199 (0.50%)	2/209 (0.96%)
Headache ^† 1	14/199 (7.04%)	31/209 (14.83%)
Sinus headache ^† 1	1/199 (0.50%)	1/209 (0.48%)
Sciatica ^† 1	0/199 (0.00%)	1/209 (0.48%)
Amnesia ^† 1	1/199 (0.50%)	2/209 (0.96%)
Memory impairment ^† 1	0/199 (0.00%)	1/209 (0.48%)
Cognitive disorder ^† 1	0/199 (0.00%)	2/209 (0.96%)
Disturbance in attention ^† 1	0/199 (0.00%)	6/209 (2.87%)
Migraine ^† 1	6/199 (3.02%)	2/209 (0.96%)
Multiple sclerosis ^† 1	2/199 (1.01%)	0/209 (0.00%)
Hypertonia ^† 1	0/199 (0.00%)	1/209 (0.48%)
Dizziness ^† 1	11/199 (5.53%)	12/209 (5.74%)
Myoclonus ^† 1	2/199 (1.01%)	0/209 (0.00%)
Muscle spasticity ^† 1	4/199 (2.01%)	1/209 (0.48%)
Optic neuritis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Burning sensation ^† 1	1/199 (0.50%)	0/209 (0.00%)
Dysaesthesia ^† 1	1/199 (0.50%)	1/209 (0.48%)
Hypoaesthesia ^† 1	6/199 (3.02%)	7/209 (3.35%)
Hypoaesthesia oral ^† 1	0/199 (0.00%)	1/209 (0.48%)
Lhermitte's sign ^† 1	0/199 (0.00%)	1/209 (0.48%)
Paraesthesia ^† 1	6/199 (3.02%)	9/209 (4.31%)
Diplegia ^† 1	1/199 (0.50%)	0/209 (0.00%)
Hemiparesis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Convulsion ^† 1	0/199 (0.00%)	2/209 (0.96%)
Dysgeusia ^† 1	2/199 (1.01%)	6/209 (2.87%)
Loss of proprioception ^† 1	0/199 (0.00%)	1/209 (0.48%)
Neuralgia ^† 1	3/199 (1.51%)	0/209 (0.00%)
Restless leg syndrome ^† 1	1/199 (0.50%)	1/209 (0.48%)
Sensory disturbance ^† 1	0/199 (0.00%)	1/209 (0.48%)
Radicular pain ^† 1	0/199 (0.00%)	1/209 (0.48%)
Tremor ^† 1	5/199 (2.51%)	6/209 (2.87%)
Pregnancy, puerperium and perinatal conditions
Abortion ^† 1	0/199 (0.00%)	1/209 (0.48%)
Unintended pregnancy ^† 1	0/199 (0.00%)	1/209 (0.48%)
Pregnancy ^† 1	1/199 (0.50%)	0/209 (0.00%)
Psychiatric disorders
Adjustment disorder with depressed mood ^† 1	1/199 (0.50%)	0/209 (0.00%)
Affect lability ^† 1	2/199 (1.01%)	4/209 (1.91%)
Agitation ^† 1	0/199 (0.00%)	3/209 (1.44%)
Anxiety ^† 1	4/199 (2.01%)	9/209 (4.31%)
Nervousness ^† 1	0/199 (0.00%)	1/209 (0.48%)
Stress ^† 1	1/199 (0.50%)	0/209 (0.00%)
Tension ^† 1	0/199 (0.00%)	1/209 (0.48%)
Attention deficit/hyperactivity disorder ^† 1	0/199 (0.00%)	1/209 (0.48%)
Aggression ^† 1	0/199 (0.00%)	1/209 (0.48%)
Irritability ^† 1	1/199 (0.50%)	0/209 (0.00%)
Disorientation ^† 1	1/199 (0.50%)	0/209 (0.00%)
Depression ^† 1	10/199 (5.03%)	9/209 (4.31%)
Insomnia ^† 1	22/199 (11.06%)	44/209 (21.05%)
Anger ^† 1	0/199 (0.00%)	1/209 (0.48%)
Mood altered ^† 1	0/199 (0.00%)	3/209 (1.44%)
Mood swings ^† 1	1/199 (0.50%)	3/209 (1.44%)
Restlessness ^† 1	0/199 (0.00%)	2/209 (0.96%)
Depressed mood ^† 1	2/199 (1.01%)	2/209 (0.96%)
Panic disorder ^† 1	0/199 (0.00%)	1/209 (0.48%)
Panic attack ^† 1	0/199 (0.00%)	2/209 (0.96%)
Abnormal dreams ^† 1	1/199 (0.50%)	0/209 (0.00%)
Nightmare ^† 1	0/199 (0.00%)	2/209 (0.96%)
Illusion ^† 1	0/199 (0.00%)	1/209 (0.48%)
Claustrophobia ^† 1	1/199 (0.50%)	0/209 (0.00%)
Speech disorder ^† 1	0/199 (0.00%)	1/209 (0.48%)
Bruxism ^† 1	0/199 (0.00%)	1/209 (0.48%)
Suicidal ideation ^† 1	0/199 (0.00%)	3/209 (1.44%)
Renal and urinary disorders
Dysuria ^† 1	1/199 (0.50%)	1/209 (0.48%)
Micturition urgency ^† 1	1/199 (0.50%)	1/209 (0.48%)
Pollakiuria ^† 1	1/199 (0.50%)	6/209 (2.87%)
Stress incontinence ^† 1	0/199 (0.00%)	1/209 (0.48%)
Urinary incontinence ^† 1	2/199 (1.01%)	1/209 (0.48%)
Urinary retention ^† 1	2/199 (1.01%)	2/209 (0.96%)
Neurogenic bladder ^† 1	1/199 (0.50%)	0/209 (0.00%)
Nephrolithiasis ^† 1	1/199 (0.50%)	1/209 (0.48%)
Haematuria ^† 1	2/199 (1.01%)	1/209 (0.48%)
Proteinuria ^† 1	1/199 (0.50%)	0/209 (0.00%)
Nocturia ^† 1	0/199 (0.00%)	1/209 (0.48%)
Reproductive system and breast disorders
Breast disorder ^† 1	1/199 (0.50%)	0/209 (0.00%)
Breast pain ^† 1	0/199 (0.00%)	1/209 (0.48%)
Erectile dysfunction ^† 1	0/199 (0.00%)	1/209 (0.48%)
Hot flush ^† 1	0/199 (0.00%)	1/209 (0.48%)
Menstrual disorder ^† 1	0/199 (0.00%)	1/209 (0.48%)
Menstruation irregular ^† 1	0/199 (0.00%)	2/209 (0.96%)
Amenorrhoea ^† 1	0/199 (0.00%)	1/209 (0.48%)
Menorrhagia ^† 1	0/199 (0.00%)	2/209 (0.96%)
Metrorrhagia ^† 1	0/199 (0.00%)	1/209 (0.48%)
Ovarian cyst ^† 1	0/199 (0.00%)	1/209 (0.48%)
Ovarian mass ^† 1	1/199 (0.50%)	0/209 (0.00%)
Benign prostatic hyperplasia ^† 1	0/199 (0.00%)	1/209 (0.48%)
Sexual dysfunction ^† 1	1/199 (0.50%)	0/209 (0.00%)
Uterine haemorrhage ^† 1	0/199 (0.00%)	1/209 (0.48%)
Uterine mass ^† 1	0/199 (0.00%)	1/209 (0.48%)
Genital pruritus female ^† 1	1/199 (0.50%)	0/209 (0.00%)
Vaginal ulceration ^† 1	1/199 (0.50%)	0/209 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	3/199 (1.51%)	10/209 (4.78%)
Asthma ^† 1	0/199 (0.00%)	1/209 (0.48%)
Cough ^† 1	4/199 (2.01%)	7/209 (3.35%)
Laryngeal erythema ^† 1	0/199 (0.00%)	1/209 (0.48%)
Hiccups ^† 1	0/199 (0.00%)	2/209 (0.96%)
Nasal congestion ^† 1	5/199 (2.51%)	2/209 (0.96%)
Epistaxis ^† 1	3/199 (1.51%)	2/209 (0.96%)
Sinus congestion ^† 1	2/199 (1.01%)	2/209 (0.96%)
Pharyngeal erythema ^† 1	0/199 (0.00%)	1/209 (0.48%)
Pleurisy ^† 1	0/199 (0.00%)	1/209 (0.48%)
Pulmonary congestion ^† 1	1/199 (0.50%)	1/209 (0.48%)
Aspiration ^† 1	0/199 (0.00%)	1/209 (0.48%)
Dysphonia ^† 1	2/199 (1.01%)	2/209 (0.96%)
Pharyngolaryngeal pain ^† 1	7/199 (3.52%)	9/209 (4.31%)
Rhinorrhoea ^† 1	2/199 (1.01%)	0/209 (0.00%)
Sinus headache ^† 1	1/199 (0.50%)	0/209 (0.00%)
Skin and subcutaneous tissue disorders
Acne ^† 1	0/199 (0.00%)	8/209 (3.83%)
Alopecia ^† 1	3/199 (1.51%)	1/209 (0.48%)
Hyperhidrosis ^† 1	0/199 (0.00%)	2/209 (0.96%)
Night sweats ^† 1	0/199 (0.00%)	1/209 (0.48%)
Dry skin ^† 1	1/199 (0.50%)	2/209 (0.96%)
Hypoaesthesia facial ^† 1	1/199 (0.50%)	1/209 (0.48%)
Skin warm ^† 1	0/199 (0.00%)	1/209 (0.48%)
Swelling face ^† 1	1/199 (0.50%)	6/209 (2.87%)
Dermatitis contact ^† 1	1/199 (0.50%)	0/209 (0.00%)
Erythema ^† 1	1/199 (0.50%)	2/209 (0.96%)
Lipoatrophy ^† 1	3/199 (1.51%)	0/209 (0.00%)
Ingrowing nail ^† 1	1/199 (0.50%)	0/209 (0.00%)
Rash papular ^† 1	1/199 (0.50%)	0/209 (0.00%)
Pruritus ^† 1	5/199 (2.51%)	0/209 (0.00%)
Pruritus generalised ^† 1	2/199 (1.01%)	0/209 (0.00%)
Rash pruritic ^† 1	0/199 (0.00%)	1/209 (0.48%)
Psoriasis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Ecchymosis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Rash ^† 1	4/199 (2.01%)	12/209 (5.74%)
Subcutaneous nodule ^† 1	1/199 (0.50%)	0/209 (0.00%)
Scar ^† 1	1/199 (0.50%)	1/209 (0.48%)
Urticaria ^† 1	4/199 (2.01%)	2/209 (0.96%)
Social circumstances
Alcohol use ^† 1	0/199 (0.00%)	1/209 (0.48%)
Surgical and medical procedures
Tooth extraction ^† 1	2/199 (1.01%)	1/209 (0.48%)
Inguinal hernia repair ^† 1	1/199 (0.50%)	0/209 (0.00%)
Thyroid operation ^† 1	1/199 (0.50%)	0/209 (0.00%)
Uterine dilation and curettage ^† 1	0/199 (0.00%)	1/209 (0.48%)
Uterine prolapse repair ^† 1	1/199 (0.50%)	0/209 (0.00%)
Vascular disorders
Aortic arteriosclerosis ^† 1	0/199 (0.00%)	1/209 (0.48%)
Haematoma ^† 1	1/199 (0.50%)	0/209 (0.00%)
Flushing ^† 1	3/199 (1.51%)	15/209 (7.18%)
Hot flush ^† 1	0/199 (0.00%)	1/209 (0.48%)
Femoral arterial stenosis ^† 1	1/199 (0.50%)	0/209 (0.00%)
Hypertension ^† 1	4/199 (2.01%)	5/209 (2.39%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA (9.0)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Director, Clinical Research
Organization:	Teva Branded Pharmaceutical Products, R&D Inc.
Phone:	215-591-3000
EMail:	ustevatrials@tevapharm.com

Publications of Results:

Milo R, Panitch H. Combination therapy in multiple sclerosis. J Neuroimmunol. 2011 Feb;231(1-2):23-31. doi: 10.1016/j.jneuroim.2010.10.021. Epub 2010 Dec 15.

Layout table for additonal information

Responsible Party:	Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier:	NCT00203047
Other Study ID Numbers:	TNC GA MS 2004_01
First Submitted:	September 13, 2005
First Posted:	September 20, 2005
Results First Submitted:	August 29, 2013
Results First Posted:	January 6, 2014
Last Update Posted:	January 6, 2014

To Top