Trial Outcomes & Findings for Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis (NCT NCT01058005)

NCT ID: NCT01058005

Last Updated: 2014-09-03

Results Overview

An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also have been any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above. See Adverse Events section below for further details.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 84 participants
• Primary outcome timeframe: up to 108 Weeks
• Results posted on: 2014-09-03

Participant Flow

Participant milestones

Measure	Natalizumab 300 mg intravenous injection every 4 weeks	Interferon Beta-1a 44 mcg subcutaneous injection 3 times per week	Glatiramer Acetate 20 mg subcutaneous injection once daily
Overall Study STARTED	38	25	21
Overall Study Dosed With Study Treatment	36	22	17
Overall Study COMPLETED	0	0	1
Overall Study NOT COMPLETED	38	25	20

Reasons for withdrawal

Measure	Natalizumab 300 mg intravenous injection every 4 weeks	Interferon Beta-1a 44 mcg subcutaneous injection 3 times per week	Glatiramer Acetate 20 mg subcutaneous injection once daily
Overall Study Adverse Event	0	2	1
Overall Study Physician Decision	2	2	0
Overall Study Withdrawal by Subject	4	5	11
Overall Study Withdrawn Due to Study Termination	27	13	7
Overall Study Reason Missing	5	3	1

Baseline Characteristics

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

Baseline characteristics by cohort

Measure	Natalizumab n=36 Participants 300 mg intravenous injection every 4 weeks	Interferon Beta-1a n=22 Participants 44 mcg subcutaneous injection 3 times per week	Glatiramer Acetate n=17 Participants 20 mg subcutaneous injection once daily	Total n=75 Participants Total of all reporting groups
Age, Continuous	35.8 years STANDARD_DEVIATION 9.51 • n=5 Participants	39.0 years STANDARD_DEVIATION 10.0 • n=7 Participants	37.6 years STANDARD_DEVIATION 13.16 • n=5 Participants	37.1 years STANDARD_DEVIATION 10.52 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	59 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants

PRIMARY outcome

Timeframe: up to 108 Weeks

Population: Participants who received at least 1 dose of study medication.

An SAE was defined as any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the subject at immediate risk of death (a life-threatening event; however, this does not include an event that, had it occurred in a more severe form, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; or results in a congenital anomaly/birth defect. An SAE may also have been any other medically important event that, in the opinion of the Investigator, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above. See Adverse Events section below for further details.

Outcome measures

Measure	Natalizumab n=36 Participants 300 mg intravenous injection every 4 weeks	Interferon Beta-1a n=22 Participants 44 mcg subcutaneous injection 3 times per week	Glatiramer Acetate n=17 Participants 20 mg subcutaneous injection once daily
Incidence of Treatment-emergent Serious Adverse Events (SAEs)	1 participants	1 participants	0 participants

Adverse Events

Natalizumab

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Interferon Beta-1a

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Glatiramer Acetate

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Natalizumab n=36 participants at risk 300 mg intravenous injection every 4 weeks	Interferon Beta-1a n=22 participants at risk 44 mcg subcutaneous injection 3 times per week	Glatiramer Acetate n=17 participants at risk 20 mg subcutaneous injection once daily
Infections and infestations Meningitis Herpes	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	4.5% 1/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Cancer	2.8% 1/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Nervous system disorders Cerebral Venous Thrombosis	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	4.5% 1/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).

Other adverse events

Measure	Natalizumab n=36 participants at risk 300 mg intravenous injection every 4 weeks	Interferon Beta-1a n=22 participants at risk 44 mcg subcutaneous injection 3 times per week	Glatiramer Acetate n=17 participants at risk 20 mg subcutaneous injection once daily
Infections and infestations Urinary Tract Infection	13.9% 5/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Infections and infestations Bronchitis	5.6% 2/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	4.5% 1/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Infections and infestations Nasopharyngitis	8.3% 3/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	4.5% 1/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Infections and infestations Sinusitis	8.3% 3/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Infections and infestations Upper Respiratory Tract Infection	5.6% 2/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	4.5% 1/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Infections and infestations Vulvovaginal Mycotic Infection	2.8% 1/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Infections and infestations Cystitis	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Infections and infestations Gastritis Viral	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Infections and infestations Gastroenteritis	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Infections and infestations Herpes Zoster	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Infections and infestations Hordeolum	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Infections and infestations Influenza	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Infections and infestations Tooth Infection	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Blood and lymphatic system disorders Lymphadenopathy	2.8% 1/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Blood and lymphatic system disorders Anaemia Macrocytic	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Metabolism and nutrition disorders Fluid Retention	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Metabolism and nutrition disorders Vitamin B12 Deficiency	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Psychiatric disorders Anxiety	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	9.1% 2/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Psychiatric disorders Insomnia	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Psychiatric disorders Stress	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Nervous system disorders Multiple Sclerosis Relapse	2.8% 1/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	13.6% 3/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	29.4% 5/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Nervous system disorders Headache	13.9% 5/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	9.1% 2/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Nervous system disorders Paraesthesia	8.3% 3/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	13.6% 3/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Nervous system disorders Hypoaesthesia	2.8% 1/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	13.6% 3/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Nervous system disorders Migraine	5.6% 2/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	4.5% 1/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Nervous system disorders Dizziness	5.6% 2/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	4.5% 1/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Nervous system disorders Loss Of Proprioception	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	11.8% 2/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Nervous system disorders Neuralgia	5.6% 2/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Nervous system disorders Hyperaesthesia	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Nervous system disorders Hypertonia	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Nervous system disorders Memory Impairment	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Nervous system disorders Orthostatic Tremor	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Eye disorders Vision Blurred	2.8% 1/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Eye disorders Vitreous Floaters	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Ear and labyrinth disorders Vertigo	2.8% 1/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	9.1% 2/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Respiratory, thoracic and mediastinal disorders Cough	5.6% 2/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	5.6% 2/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Congestion	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Gastrointestinal disorders Nausea	16.7% 6/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	9.1% 2/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Gastrointestinal disorders Vomiting	8.3% 3/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	13.6% 3/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Gastrointestinal disorders Constipation	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	11.8% 2/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Gastrointestinal disorders Diarrhoea	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	4.5% 1/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Gastrointestinal disorders Dysphagia	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	4.5% 1/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Gastrointestinal disorders Gastrointestinal Disorder	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Gastrointestinal disorders Periodontal Disease	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Skin and subcutaneous tissue disorders Alopecia	5.6% 2/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Skin and subcutaneous tissue disorders Subcutaneous Nodule	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Musculoskeletal and connective tissue disorders Pain In Extremity	2.8% 1/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	4.5% 1/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	11.8% 2/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Musculoskeletal and connective tissue disorders Myalgia	2.8% 1/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	9.1% 2/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	11.8% 2/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Musculoskeletal and connective tissue disorders Muscle Fatigue	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Renal and urinary disorders Urinary Incontinence	2.8% 1/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Renal and urinary disorders Micturition Urgency	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
General disorders Fatigue	11.1% 4/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	9.1% 2/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	17.6% 3/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
General disorders Gait Disturbance	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	9.1% 2/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
General disorders Pyrexia	5.6% 2/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	4.5% 1/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
General disorders Injection Site Reaction	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	11.8% 2/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
General disorders Influenza Like Illness	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
General disorders Injection Site Mass	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
General disorders Injection Site Pruritus	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
General disorders Injection Site Swelling	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Investigations Heart Rate Increased	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Investigations Vitamin D Decreased	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Injury, poisoning and procedural complications Fall	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	9.1% 2/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Injury, poisoning and procedural complications Contusion	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Injury, poisoning and procedural complications Exposure To Toxic Agent	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).
Injury, poisoning and procedural complications Tibia Fracture	0.00% 0/36 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	0.00% 0/22 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).	5.9% 1/17 • Adverse events (AEs) were collected from the time of first dose of study treatment until the final clinic visit (96 weeks); serious adverse events (SAEs) were collected from the time of signed consent to 12 weeks after the last study visit (108 weeks).

Additional Information

Biogen Idec Study Medical Director

Biogen Idec

Email: clinicaltrials@biogenidec.com

Results disclosure agreements

• Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
• Publication restrictions are in place

Restriction type: OTHER