A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis

• ClinicalTrials.gov Identifier: NCT01047319
• Recruitment Status: Terminated
• First Posted: January 12, 2010
• Results First Posted: January 9, 2019
• Last Update Posted: January 9, 2019
• Sponsor: Teva Pharmaceutical Industries, Ltd.
• Information provided by (Responsible Party): Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Relapsing Multiple Sclerosis
• Intervention: Drug: Laquinimod
• Enrollment: 1047

Participant Flow

Recruitment Details	All participants who completed the full duration of the double-blind BRAVO study (study MS-LAQ-302) were eligible to enter into Study MS-LAQ-302E. Of the 1090 participants who completed MS-LAQ-302, 1047 opted to continue into the open-label extension study.
Pre-assignment Details	1047 subjects with RRMS were enrolled to receive laquinimod 0.6 mg daily at 144 study sites in 18 countries by 144 investigators.

Arm/Group Title	Early Laquinimod	Switch From Placebo	Switch From Avonex
Arm/Group Description	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
Period Title: Overall Study
Started	345	350	352
Completed	0	0	0
Not Completed	345	350	352
Reason Not Completed
Teva requested participant withdrawal	3	0	1
Protocol Violation	3	2	4
Lack of Efficacy	4	3	3
Death	5	1	5
Pregnancy	13	8	8
Physician Decision	12	9	10
Lost to Follow-up	14	10	10
Adverse Event	16	27	21
Withdrawal by Subject	77	75	87
Study terminated by Sponsor	198	215	203

Baseline Characteristics

Arm/Group Title		Early Laquinimod	Switch From Placebo	Switch From Avonex	Total
Arm/Group Description		All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.	Total of all reporting groups
Overall Number of Baseline Participants		345	350	352	1047
Baseline Analysis Population Description		Participants enrolled in the MS-LAQ-302 extension study.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	345 participants	350 participants	352 participants	1047 participants
		39.2 (9.16)	40.1 (9.23)	40.1 (9.34)	39.8 (9.24)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	345 participants	350 participants	352 participants	1047 participants
	Female	228 66.1%	245 70.0%	234 66.5%	707 67.5%
	Male	117 33.9%	105 30.0%	118 33.5%	340 32.5%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	345 participants	350 participants	352 participants	1047 participants
	Asian/Oriental	1 0.3%	0 0.0%	1 0.3%	2 0.2%
	Black/African American	2 0.6%	2 0.6%	2 0.6%	6 0.6%
	White	338 98.0%	346 98.9%	348 98.9%	1032 98.6%
	Unknown	2 0.6%	2 0.6%	0 0.0%	4 0.4%
	Other	2 0.6%	0 0.0%	1 0.3%	3 0.3%

Outcome Measures

1. Primary Outcome

Title	Participants With Treatment-Emergent Adverse Events (TEAEs)
Description	A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. TEAEs associated with cancer, ischemic heart disease, cerebrovascular events, and arthritis were considered to be of special interest.
Time Frame	Day 1 up to 7.13 years

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Early Laquinimod	Switch From Placebo	Switch From Avonex
Arm/Group Description:	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
Overall Number of Participants Analyzed	345	350	352
Measure Type: Count of Participants; Unit of Measure: Participants
=>1 TEAE	290 84.1%	303 86.6%	279 79.3%
=>1 Serious TEAE	54 15.7%	65 18.6%	51 14.5%
=>1 Severe TEAE	36 10.4%	54 15.4%	44 12.5%
=>1 TEAE causing discontinuation	20 5.8%	28 8.0%	23 6.5%
=>1 TEAE of special interest	66 19.1%	64 18.3%	73 20.7%
=>1 treatment-related TEAE	66 19.1%	76 21.7%	96 27.3%
=>1 TEAE leading to death	5 1.4%	3 0.9%	5 1.4%

2. Secondary Outcome

Title	Participants With Potentially Clinically Significant Abnormal Vital Signs
Description	Vital signs with potentially clinically significant abnormal results were evaluated using the following significance criteria: Pulse rate: >=120 and increase >=30 beats/minute; Systolic blood pressure low: <=90 and decrease >=30 mmHg; Systolic blood pressure high: >=180 and increase >=30 mmHg; Diastolic blood pressure low: <=50 and decrease >=20 mmHg; Diastolic blood pressure high: >=100 and increase >=20 mmHg Note that the change is compared to baseline,
Time Frame	Baseline (Day 0 for extension), Day 1 up to 7.13 years

Outcome Measure Data

Analysis Population Description

Safety analysis set of participants with a baseline and post-baseline value for that vital sign,

Arm/Group Title	Early Laquinimod	Switch From Placebo	Switch From Avonex
Arm/Group Description:	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
Overall Number of Participants Analyzed	345	350	352
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with at least one abnormality	19 5.5%	23 6.6%	19 5.4%
Pulse rate - high	2 0.6%	0 0.0%	0 0.0%
Systolic blood pressure - low	4 1.2%	7 2.0%	9 2.6%
Systolic blood pressure - high	0 0.0%	2 0.6%	0 0.0%
Diastolic blood pressure - low	4 1.2%	5 1.4%	4 1.1%
Diastolic blood pressure - high	9 2.6%	10 2.9%	7 2.0%

3. Secondary Outcome

Title	Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Description	Counts include two conditions: a change from High / Non-PCS at baseline to Low PCS at any point during the study; a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non-PCS value are included in the population count. ALT=alanine aminotransferase ALP=alkaline phosphatase P-amylase=amylase, pancreatic AST=aspartate aminotransferase CRP=C reactive protein CK=creatine kinase CTN=creatinine FIB=fibrinogen GGT=gamma glutamyl transferase K=potassium
Time Frame	Baseline (Day 0), Day 1 to 7.13 years

Outcome Measure Data

Analysis Population Description

Safety analysis set of participants with both a baseline and a post-baseline value for the test.

Arm/Group Title	Early Laquinimod	Switch From Placebo	Switch From Avonex
Arm/Group Description:	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
Overall Number of Participants Analyzed	344	349	347
Measure Type: Count of Participants; Unit of Measure: Participants
ALT - change from Low / Non-PCS to High PCS	5 1.5%	8 2.3%	10 2.9%
Albumen - change from High / Non-PCS to Low PCS	0 0.0%	1 0.3%	0 0.0%
ALP - change from Low / Non-PCS to High PCS	0 0.0%	2 0.6%	0 0.0%
p-Amylase - change from Low / Non-PCS to High PCS	5 1.5%	1 0.3%	2 0.6%
AST - change from Low / Non-PCS to High PCS	3 0.9%	2 0.6%	5 1.4%
Bilirubin - change from Low / Non-PCS to High PCS	2 0.6%	3 0.9%	2 0.6%
CRP - change from Low / Non-PCS to High PCS	36 10.5%	32 9.2%	31 8.9%
Calcium - change from High / Non-PCS to Low PCS	1 0.3%	1 0.3%	1 0.3%
Calcium - change from Low / Non-PCS to High PCS	1 0.3%	1 0.3%	2 0.6%
CK - change from Low / Non-PCS to High PCS	11 3.2%	12 3.4%	10 2.9%
CTN - change from Low / Non-PCS to High PCS	1 0.3%	1 0.3%	0 0.0%
FIB - change from Low / Non-PCS to High PCS	22 6.4%	24 6.9%	25 7.2%
GGT - change from Low / Non-PCS to High PCS	16 4.7%	22 6.3%	18 5.2%
Glucose - change from High / Non-PCS to Low PCS	12 3.5%	16 4.6%	11 3.2%
Glucose - change from Low / Non-PCS to High PCS	4 1.2%	5 1.4%	2 0.6%
Phosphate-change from High / Non-PCS to Low PCS	12 3.5%	12 3.4%	6 1.7%
Phosphate-change from Low / Non-PCS to High PCS	17 4.9%	18 5.2%	16 4.6%
K - change from High / Non-PCS to Low PCS	2 0.6%	4 1.1%	2 0.6%
K - change from Low / Non-PCS to High PCS	46 13.4%	39 11.2%	38 11.0%
Sodium - change from High / Non-PCS to Low PCS	4 1.2%	2 0.6%	3 0.9%
Sodium - change from Low / Non-PCS to High PCS	21 6.1%	16 4.6%	17 4.9%
Urea - change from Low / Non-PCS to High PCS	4 1.2%	4 1.1%	3 0.9%

4. Secondary Outcome

Title	Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Description	Counts include two conditions: a change from High / Non-PCS at baseline to Low PCS at any point during the study; a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non-PCS value are included in the population count.
Time Frame	Baseline (Day 0), Day 1 to 7.13 years

Outcome Measure Data

Analysis Population Description

Safety analysis set of participants with both a baseline and a post-baseline value for the test.

Arm/Group Title	Early Laquinimod	Switch From Placebo	Switch From Avonex
Arm/Group Description:	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
Overall Number of Participants Analyzed	344	349	347
Measure Type: Count of Participants; Unit of Measure: Participants
Hematocrit - change from High / Non-PCS to Low PCS	30 8.7%	25 7.2%	21 6.1%
Hemoglobin -change from High / Non-PCS to Low PCS	21 6.1%	24 6.9%	15 4.3%
Leukocytes - change from High / Non-PCS to Low PCS	2 0.6%	4 1.1%	2 0.6%
Leukocytes - change from Low / Non-PCS to High PCS	4 1.2%	1 0.3%	5 1.4%
Neutrophils - change from High/Non-PCS to Low PCS	25 7.3%	12 3.4%	14 4.0%
Platelets - change from High / Non-PCS to Low PCS	5 1.5%	3 0.9%	2 0.6%
Platelets - change from Low / Non-PCS to High PCS	4 1.2%	4 1.1%	4 1.2%

5. Secondary Outcome

Title	Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Description	Shifts are presented as Baseline finding / Worse finding at anytime during the study. Categories for findings are: normal; abnormal, not clinically significant (Not CS); abnormal, clinically significant (CS)
Time Frame	Baseline (Day 0), Day 1 to 7.13 years

Outcome Measure Data

Analysis Population Description

Safety analysis set of participants with both a baseline and a post-baseline ECG.

Arm/Group Title	Early Laquinimod	Switch From Placebo	Switch From Avonex
Arm/Group Description:	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.	All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
Overall Number of Participants Analyzed	340	346	345
Measure Type: Count of Participants; Unit of Measure: Participants
Normal / Normal	150 44.1%	148 42.8%	134 38.8%
Normal / Abnormal, Not CS	109 32.1%	125 36.1%	119 34.5%
Normal / Abnormal, CS	5 1.5%	3 0.9%	5 1.4%
Abnormal, Not CS / Normal	5 1.5%	7 2.0%	20 5.8%
Abnormal, Not CS / Abnormal, Not CS	67 19.7%	62 17.9%	64 18.6%
Abnormal, Not CS / Abnormal, CS	4 1.2%	0 0.0%	2 0.6%
Abnormal, CS / Normal	0 0.0%	0 0.0%	0 0.0%
Abnormal, CS / Abnormal, Not CS	0 0.0%	0 0.0%	1 0.3%
Abnormal, CS / Abnormal, CS	0 0.0%	1 0.3%	0 0.0%

Adverse Events

Time Frame	Day 1 up to 7.13 years
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Early Laquinimod		Switch From Placebo		Switch From Avonex
Arm/Group Description	All participants in MS-LAQ- 302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.		All participants in MS-LAQ- 302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from Placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.		All participants in MS-LAQ- 302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
All-Cause Mortality
	Early Laquinimod		Switch From Placebo		Switch From Avonex
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	5/345 (1.45%)		3/350 (0.86%)		5/352 (1.42%)
Serious Adverse Events
	Early Laquinimod		Switch From Placebo		Switch From Avonex
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	54/345 (15.65%)		65/350 (18.57%)		51/352 (14.49%)
Blood and lymphatic system disorders
Iron deficiency anaemia † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Thrombocytopenia † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Cardiac disorders
Acute left ventricular failure † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Acute myocardial infarction † 1	2/345 (0.58%)	2	0/350 (0.00%)	0	2/352 (0.57%)	2
Arrhythmia † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Atrial flutter † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Cardiac failure † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Cardiac failure acute † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Cardiac failure congestive † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Cardiopulmonary failure † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Cardiovascular insufficiency † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Coronary artery dissection † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Coronary artery stenosis † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Left ventricular failure † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Myocardial infarction † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	3/352 (0.85%)	3
Stress cardiomyopathy † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Supraventricular tachycardia † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	1/352 (0.28%)	1
Ventricular extrasystoles † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Ventricular fibrillation † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Congenital, familial and genetic disorders
Hydrocele † 1	1/345 (0.29%)	1	1/350 (0.29%)	1	0/352 (0.00%)	0
Ear and labyrinth disorders
Vertigo † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Endocrine disorders
Adrenal mass † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Goitre † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Hyperthyroidism † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Eye disorders
Blepharitis † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Cataract nuclear † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Iridocyclitis † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Ocular hypertension † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Gastrointestinal disorders
Abdominal hernia † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Abdominal pain † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Anal fissure † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Faecaloma † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Inflammatory bowel disease † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Inguinal hernia † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Irritable bowel syndrome † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	2
Large intestinal obstruction † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Large intestine perforation † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Pancreatitis † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Pancreatitis acute † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Pancreatitis chronic † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Proctitis † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Vomiting † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
General disorders
Pyrexia † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Hepatobiliary disorders
Cholangitis † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Cholecystitis † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	1/352 (0.28%)	1
Cholecystitis chronic † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Cholelithiasis † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	1/352 (0.28%)	1
Hepatitis toxic † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Immune system disorders
Allergy to metals † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Food allergy † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Infections and infestations
Abdominal wall abscess † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Acute hepatitis C † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Appendicitis † 1	2/345 (0.58%)	2	0/350 (0.00%)	0	1/352 (0.28%)	1
Bronchitis † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	1/352 (0.28%)	1
Carbuncle † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Cellulitis † 1	1/345 (0.29%)	1	1/350 (0.29%)	1	0/352 (0.00%)	0
Chorioretinitis † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Cystitis † 1	2/345 (0.58%)	2	0/350 (0.00%)	0	0/352 (0.00%)	0
Diverticulitis † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	1/352 (0.28%)	1
Escherichia sepsis † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
HIV infection † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Herpes zoster † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Incision site abscess † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Infectious pleural effusion † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Lung abscess † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Meningitis viral † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Orchitis † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Papilloma viral infection † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Peritonitis † 1	2/345 (0.58%)	2	1/350 (0.29%)	1	1/352 (0.28%)	1
Pilonidal cyst † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	2/352 (0.57%)	2
Pneumonia † 1	1/345 (0.29%)	1	1/350 (0.29%)	1	2/352 (0.57%)	2
Pulmonary tuberculosis † 1	1/345 (0.29%)	1	1/350 (0.29%)	1	2/352 (0.57%)	2
Pyelonephritis † 1	1/345 (0.29%)	1	1/350 (0.29%)	1	0/352 (0.00%)	0
Salpingo-oophoritis † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Tuberculosis † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	2/352 (0.57%)	2
Urinary tract infection † 1	3/345 (0.87%)	3	1/350 (0.29%)	1	2/352 (0.57%)	2
Viral pharyngitis † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Viral upper respiratory tract infection † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Wound infection staphylococcal † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Injury, poisoning and procedural complications
Accident † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Animal bite † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Ankle fracture † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Cervical vertebral fracture † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Concussion † 1	1/345 (0.29%)	1	1/350 (0.29%)	1	0/352 (0.00%)	0
Contusion † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Craniocerebral injury † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Epiphyseal fracture † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Facial bones fracture † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Fall † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	1/352 (0.28%)	1
Femur fracture † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Humerus fracture † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	1/352 (0.28%)	1
Joint dislocation † 1	0/345 (0.00%)	0	2/350 (0.57%)	2	0/352 (0.00%)	0
Ligament sprain † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Meniscus injury † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Pneumothorax traumatic † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Radius fracture † 1	0/345 (0.00%)	0	2/350 (0.57%)	2	0/352 (0.00%)	0
Road traffic accident † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	1/352 (0.28%)	1
Skeletal injury † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Splenic rupture † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Subdural haematoma † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Tibia fracture † 1	1/345 (0.29%)	1	1/350 (0.29%)	1	0/352 (0.00%)	0
Ulna fracture † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Upper limb fracture † 1	1/345 (0.29%)	1	1/350 (0.29%)	1	0/352 (0.00%)	0
Ureteric injury † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Wound † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Investigations
Hepatic enzyme increased † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Metabolism and nutrition disorders
Lactose intolerance † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Musculoskeletal and connective tissue disorders
Back pain † 1	2/345 (0.58%)	2	1/350 (0.29%)	1	0/352 (0.00%)	0
Bursitis † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Intervertebral disc protrusion † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	1/352 (0.28%)	1
Jaw cyst † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Myalgia † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Osteoarthritis † 1	2/345 (0.58%)	2	2/350 (0.57%)	2	0/352 (0.00%)	0
Pain in extremity † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Spinal osteoarthritis † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Adenocarcinoma † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Adenocarcinoma of colon † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Basal cell carcinoma † 1	1/345 (0.29%)	1	1/350 (0.29%)	1	0/352 (0.00%)	0
Breast cancer † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Breast cancer stage II † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Cervix carcinoma stage II † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Fibrous histiocytoma † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Intraductal proliferative breast lesion † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Invasive ductal breast carcinoma † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	1/352 (0.28%)	1
Keratoacanthoma † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Malignant melanoma † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Malignant melanoma in situ † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Malignant neoplasm of renal pelvis † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Metastases to liver † 1	0/345 (0.00%)	0	2/350 (0.57%)	2	0/352 (0.00%)	0
Neuroma † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Non-small cell lung cancer metastatic † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Papillary thyroid cancer † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Rectal adenocarcinoma † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Rectal cancer † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	1/352 (0.28%)	1
Squamous cell carcinoma of the cervix † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Uterine cancer † 1	0/345 (0.00%)	0	2/350 (0.57%)	2	0/352 (0.00%)	0
Uterine leiomyoma † 1	3/345 (0.87%)	4	4/350 (1.14%)	4	3/352 (0.85%)	3
Nervous system disorders
Altered state of consciousness † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Brain oedema † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Cerebral haemorrhage † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Dizziness † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Epilepsy † 1	1/345 (0.29%)	1	1/350 (0.29%)	2	1/352 (0.28%)	1
Hemiparesis † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	1/352 (0.28%)	1
Hypoaesthesia † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Ischaemic stroke † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Lumbar radiculopathy † 1	0/345 (0.00%)	0	2/350 (0.57%)	2	0/352 (0.00%)	0
Multiple sclerosis relapse † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	1/352 (0.28%)	1
Muscle spasticity † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Radiculopathy † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Sciatica † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Thrombotic stroke † 1	0/345 (0.00%)	0	1/350 (0.29%)	2	0/352 (0.00%)	0
Trigeminal neuralgia † 1	0/345 (0.00%)	0	3/350 (0.86%)	3	1/352 (0.28%)	1
Pregnancy, puerperium and perinatal conditions
Abortion missed † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Abortion spontaneous † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	1/352 (0.28%)	1
Product Issues
Device loosening † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Psychiatric disorders
Alcohol withdrawal syndrome † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Completed suicide † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Depression † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Disorientation † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Mood disorder due to a general medical condition † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Panic attack † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Renal and urinary disorders
Calculus urinary † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Crush syndrome † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Hydronephrosis † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	1/352 (0.28%)	1
Hypertonic bladder † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Micturition disorder † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Nephrolithiasis † 1	0/345 (0.00%)	0	1/350 (0.29%)	4	1/352 (0.28%)	1
Ureterolithiasis † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Urinary incontinence † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Reproductive system and breast disorders
Bartholin's cyst † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Cervical dysplasia † 1	0/345 (0.00%)	0	3/350 (0.86%)	3	0/352 (0.00%)	0
Cervical polyp † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Cervix disorder † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Endometriosis † 1	0/345 (0.00%)	0	4/350 (1.14%)	5	0/352 (0.00%)	0
Menorrhagia † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	1/352 (0.28%)	1
Menstrual disorder † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Metrorrhagia † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Ovarian cyst ruptured † 1	0/345 (0.00%)	0	2/350 (0.57%)	2	0/352 (0.00%)	0
Ovarian haemorrhage † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Pelvic adhesions † 1	1/345 (0.29%)	2	0/350 (0.00%)	0	0/352 (0.00%)	0
Postmenopausal haemorrhage † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Uterine polyp † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Vaginal cyst † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	1/352 (0.28%)	1
Chronic respiratory failure † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Paranasal cyst † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Pleural effusion † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	1/352 (0.28%)	1
Pleurisy † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Pulmonary oedema † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Surgical and medical procedures
Bartholin's cyst removal † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Cholecystectomy † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Fracture reduction † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Hysterectomy † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Inguinal hernia repair † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Osteosynthesis † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Radical hysterectomy † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Skin lesion excision † 1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/352 (0.00%)	0
Splenectomy † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Thyroidectomy † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Vascular disorders
Aortic rupture † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Circulatory collapse † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Deep vein thrombosis † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	2/352 (0.57%)	2
Hypovolaemic shock † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Internal haemorrhage † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
Jugular vein thrombosis † 1	0/345 (0.00%)	0	1/350 (0.29%)	1	0/352 (0.00%)	0
Thrombophlebitis superficial † 1	0/345 (0.00%)	0	0/350 (0.00%)	0	1/352 (0.28%)	1
1 Term from vocabulary, MedDRA 19.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Early Laquinimod		Switch From Placebo		Switch From Avonex
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	215/345 (62.32%)		205/350 (58.57%)		194/352 (55.11%)
Blood and lymphatic system disorders
Anaemia † 1	22/345 (6.38%)	34	20/350 (5.71%)	24	15/352 (4.26%)	18
Infections and infestations
Bronchitis † 1	24/345 (6.96%)	26	23/350 (6.57%)	29	16/352 (4.55%)	27
Influenza † 1	27/345 (7.83%)	34	25/350 (7.14%)	38	22/352 (6.25%)	32
Nasopharyngitis † 1	52/345 (15.07%)	96	46/350 (13.14%)	77	37/352 (10.51%)	58
Pharyngitis † 1	11/345 (3.19%)	18	18/350 (5.14%)	24	11/352 (3.13%)	15
Respiratory tract infection viral † 1	20/345 (5.80%)	25	15/350 (4.29%)	24	16/352 (4.55%)	20
Upper respiratory tract infection † 1	36/345 (10.43%)	62	36/350 (10.29%)	63	28/352 (7.95%)	59
Urinary tract infection † 1	22/345 (6.38%)	30	18/350 (5.14%)	22	17/352 (4.83%)	22
Investigations
C-reactive protein increased † 1	19/345 (5.51%)	25	17/350 (4.86%)	23	14/352 (3.98%)	16
Weight increased † 1	19/345 (5.51%)	23	11/350 (3.14%)	11	9/352 (2.56%)	10
Musculoskeletal and connective tissue disorders
Arthralgia † 1	21/345 (6.09%)	27	23/350 (6.57%)	27	28/352 (7.95%)	38
Back pain † 1	49/345 (14.20%)	74	49/350 (14.00%)	72	50/352 (14.20%)	73
Nervous system disorders
Headache † 1	44/345 (12.75%)	84	60/350 (17.14%)	121	74/352 (21.02%)	128
Psychiatric disorders
Depression † 1	26/345 (7.54%)	26	20/350 (5.71%)	21	17/352 (4.83%)	21
Vascular disorders
Hypertension † 1	18/345 (5.22%)	22	21/350 (6.00%)	23	18/352 (5.11%)	18
1 Term from vocabulary, MedDRA 19.0; † Indicates events were collected by systematic assessment

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

• Name/Title: Director, Clinical Research
• Organization: Teva Pharmaceutical Industries, Ltd
• Phone: 1-888-483-8279
• EMail: USMedInfo@tevapharm.com

• Responsible Party: Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
• ClinicalTrials.gov Identifier: NCT01047319
• Other Study ID Numbers: MS-LAQ-302E; 2009-015815-42 ( EudraCT Number )
• First Submitted: January 8, 2010
• First Posted: January 12, 2010
• Results First Submitted: November 28, 2018
• Results First Posted: January 9, 2019
• Last Update Posted: January 9, 2019