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Trial record 2 of 2 for:    BRAVO | Multiple Sclerosis | Italy

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01047319
Recruitment Status : Terminated (Sponsor terminated RRMS studies as sufficient long term clinical data was collected for the study drug in the relevant dose)
First Posted : January 12, 2010
Results First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
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
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
Hide 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
Arm/Group Title Early Laquinimod Switch From Placebo Switch From Avonex Total
Hide 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
Hide 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%
1.Primary Outcome
Title Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety
Arm/Group Title Early Laquinimod Switch From Placebo Switch From Avonex
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
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
Hide 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%)    
Hide 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
Hide 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
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research
Organization: Teva Pharmaceutical Industries, Ltd
Phone: 1-888-483-8279
EMail: USMedInfo@tevapharm.com
Layout table for additonal information
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