Trial Outcomes & Findings for An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the Disease (NCT NCT00745615)
NCT ID: NCT00745615
Last Updated: 2019-03-27
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
257 participants
Primary outcome timeframe
Baseline (Week 0) to Week 36
Results posted on
2019-03-27
Participant Flow
This study is LAQ/5063 (i.e., double-blind extension) and LAQ/5063OL (i.e., subsequent open-label extension). Participants who completed double-blind core study LAQ/5062 (NCT00349193) and agreed to continue in active extension study were enrolled in this study.
Double-blind extension: Participants treated with placebo in LAQ/5062 study were equally randomized to one of 2 groups: Laquinimod 0.6 mg or Laquinimod 0.3 mg. Participants previously treated with laquinimod 0.6 mg or laquinimod 0.3 mg continued on their original treatment. Open-label extension: All participants received laquinimod 0.6 mg.
Participant milestones
| Measure |
Double-Blind: Laquinimod 0.3 mg
Participants who were receiving laquinimod 0.3 milligram (mg) tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg
Participants who were receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for relapsing-remitting multiple sclerosis \[RRMS\]) or early discontinuation (up to approximately 10.5 years).
|
Open Label: Laquinimod 0.6 mg
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
|
|---|---|---|---|---|---|---|
|
Double-Blind Extension (36 Weeks)
STARTED
|
80
|
94
|
39
|
44
|
0
|
0
|
|
Double-Blind Extension (36 Weeks)
COMPLETED
|
75
|
87
|
38
|
39
|
0
|
0
|
|
Double-Blind Extension (36 Weeks)
NOT COMPLETED
|
5
|
7
|
1
|
5
|
0
|
0
|
|
Open-Label (up to Approx 10.5 Years)
STARTED
|
0
|
0
|
0
|
0
|
96
|
113
|
|
Open-Label (up to Approx 10.5 Years)
COMPLETED
|
0
|
0
|
0
|
0
|
5
|
5
|
|
Open-Label (up to Approx 10.5 Years)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
91
|
108
|
Reasons for withdrawal
| Measure |
Double-Blind: Laquinimod 0.3 mg
Participants who were receiving laquinimod 0.3 milligram (mg) tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg
Participants who were receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for relapsing-remitting multiple sclerosis \[RRMS\]) or early discontinuation (up to approximately 10.5 years).
|
Open Label: Laquinimod 0.6 mg
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
|
|---|---|---|---|---|---|---|
|
Double-Blind Extension (36 Weeks)
Withdrawal by Subject
|
3
|
1
|
0
|
4
|
0
|
0
|
|
Double-Blind Extension (36 Weeks)
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Double-Blind Extension (36 Weeks)
Adverse Event
|
2
|
3
|
1
|
1
|
0
|
0
|
|
Double-Blind Extension (36 Weeks)
Pregnancy
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Double-Blind Extension (36 Weeks)
Other Than Specified
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Open-Label (up to Approx 10.5 Years)
Study Terminated by Sponsor
|
0
|
0
|
0
|
0
|
50
|
50
|
|
Open-Label (up to Approx 10.5 Years)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
19
|
19
|
|
Open-Label (up to Approx 10.5 Years)
Physician Decision
|
0
|
0
|
0
|
0
|
9
|
11
|
|
Open-Label (up to Approx 10.5 Years)
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
8
|
|
Open-Label (up to Approx 10.5 Years)
Pregnancy
|
0
|
0
|
0
|
0
|
2
|
5
|
|
Open-Label (up to Approx 10.5 Years)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
3
|
|
Open-Label (up to Approx 10.5 Years)
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label (up to Approx 10.5 Years)
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Open-Label (up to Approx 10.5 Years)
Other Than Specified
|
0
|
0
|
0
|
0
|
8
|
10
|
Baseline Characteristics
An Extension Study of LAQ/5062 Exploring the Long Term Safety, Tolerability and Clinical Effect Parameters During the Disease
Baseline characteristics by cohort
| Measure |
Double-Blind: Laquinimod 0.3 mg
n=80 Participants
Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
n=94 Participants
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
n=39 Participants
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
n=44 Participants
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
34.4 years
STANDARD_DEVIATION 8.3 • n=99 Participants
|
33.4 years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
34.5 years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
31.0 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
33.5 years
STANDARD_DEVIATION 8.3 • n=31 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
154 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
103 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black of African Heritage
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
79 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
44 Participants
n=7 Participants
|
255 Participants
n=31 Participants
|
|
Region of Enrollment
Czech Republic
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
|
Region of Enrollment
Germany
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Region of Enrollment
Hungary
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Region of Enrollment
Israel
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Region of Enrollment
Italy
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Region of Enrollment
Poland
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
60 Participants
n=31 Participants
|
|
Region of Enrollment
Russia
|
18 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
69 Participants
n=31 Participants
|
|
Region of Enrollment
Spain
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to Week 36Population: ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Outcome measures
| Measure |
Double-Blind: Laquinimod 0.3 mg
n=80 Participants
Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
n=94 Participants
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
n=39 Participants
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
n=44 Participants
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
|---|---|---|---|---|
|
Double-Blind Extension Period: Number of Participants With Adverse Events (AEs)
|
57 Participants
|
66 Participants
|
23 Participants
|
32 Participants
|
PRIMARY outcome
Timeframe: Baseline (Month 0/termination visit of double-blind extension phase [completion of full 36 weeks] until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years)Population: Safety analysis set included all participants who had received at least 1 dose of study drug during the open-label extension period LAQ/5063OL.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Outcome measures
| Measure |
Double-Blind: Laquinimod 0.3 mg
n=96 Participants
Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
n=113 Participants
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
|---|---|---|---|---|
|
Open-label Extension Period: Number of Participants With AEs
|
86 Participants
|
100 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Week 0) to Week 36Population: ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
Outcome measures
| Measure |
Double-Blind: Laquinimod 0.3 mg
n=80 Participants
Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
n=94 Participants
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
n=39 Participants
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
n=44 Participants
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
|---|---|---|---|---|
|
Double-Blind Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs
Due to any reason
|
5 Participants
|
7 Participants
|
1 Participants
|
5 Participants
|
|
Double-Blind Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs
Due to AEs
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (Month 0/termination visit of double-blind extension phase [completion of full 36 weeks] until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years)Population: Safety analysis set included all participants who had received at least 1 dose of study drug during the open-label extension period LAQ/5063OL.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.
Outcome measures
| Measure |
Double-Blind: Laquinimod 0.3 mg
n=96 Participants
Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
n=113 Participants
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
|---|---|---|---|---|
|
Open-Label Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs
Due to AEs
|
1 Participants
|
9 Participants
|
—
|
—
|
|
Open-Label Period: Number of Participants Who Prematurely Discontinued From the Study Due to Any Reason and Due to AEs
Due to any reason
|
91 Participants
|
108 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36)Population: ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase.
Relapse was defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in the absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in the Expanded disability status scale (EDSS); or one grade in the score of 2 or more of the 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in the score of one of the FS as compared to the previous evaluation. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis \[MS\]).
Outcome measures
| Measure |
Double-Blind: Laquinimod 0.3 mg
n=80 Participants
Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
n=94 Participants
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
n=39 Participants
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
n=44 Participants
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
|---|---|---|---|---|
|
Double-Blind Period: Relapse Rate: Total Number of Confirmed Relapses
|
0.39 relapses
Standard Deviation 0.68
|
0.36 relapses
Standard Deviation 0.58
|
0.38 relapses
Standard Deviation 0.54
|
0.39 relapses
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Baseline (Week 0) up to end of active double-blind phase or termination/early termination visit (up to Week 36)Population: ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase.
Relapse was defined as the appearance of one or more new neurological abnormalities or the reappearance of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in the absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in the EDSS; or one grade in the score of 2 or more of the 7 FS (excluding changes in bowel or bladder function or cognition); or 2 grades in the score of one of the FS as compared to the previous evaluation. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS).
Outcome measures
| Measure |
Double-Blind: Laquinimod 0.3 mg
n=80 Participants
Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
n=94 Participants
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
n=39 Participants
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
n=44 Participants
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
|---|---|---|---|---|
|
Double-Blind Period: Percentage of Relapse-Free Participants
|
70.0 percentage of participants
|
68.1 percentage of participants
|
64.1 percentage of participants
|
72.7 percentage of participants
|
SECONDARY outcome
Timeframe: At the end of active double-blind phase or termination/early termination visit (up to Week 36)Population: ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.
Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions. T1-weighted scan was taken after administration of gadolinium-gadopentetic acid (Gd-DTPA).
Outcome measures
| Measure |
Double-Blind: Laquinimod 0.3 mg
n=66 Participants
Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
n=82 Participants
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
n=36 Participants
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
n=38 Participants
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
|---|---|---|---|---|
|
Double-Blind Period: Number of Enhancing Lesions on T1-Weighted Images
|
2.50 lesions
Standard Deviation 4.77
|
2.18 lesions
Standard Deviation 5.67
|
2.64 lesions
Standard Deviation 4.32
|
1.63 lesions
Standard Deviation 3.04
|
SECONDARY outcome
Timeframe: At the end of active double-blind phase or termination/early termination visit (up to Week 36)Population: ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.
Inflammatory disease activity was assessed by MRI measurement of the number of new T2 lesions.
Outcome measures
| Measure |
Double-Blind: Laquinimod 0.3 mg
n=66 Participants
Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
n=82 Participants
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
n=36 Participants
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
n=38 Participants
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
|---|---|---|---|---|
|
Double-Blind Period: Number of New T2 Lesions
|
4.58 lesions
Standard Deviation 8.36
|
3.55 lesions
Standard Deviation 6.76
|
4.47 lesions
Standard Deviation 6.23
|
2.42 lesions
Standard Deviation 3.45
|
SECONDARY outcome
Timeframe: At the end of active double-blind phase or termination/early termination visit (up to Week 36)Population: ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.
Volume of T2 lesion was assessed by magnetic MRI.
Outcome measures
| Measure |
Double-Blind: Laquinimod 0.3 mg
n=66 Participants
Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
n=82 Participants
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
n=36 Participants
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
n=38 Participants
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
|---|---|---|---|---|
|
Double-Blind Period: Volume of T2 Lesions
|
16930 cubic millimeters (mm^3)
Standard Deviation 12816
|
17015 cubic millimeters (mm^3)
Standard Deviation 15298
|
17436 cubic millimeters (mm^3)
Standard Deviation 16808
|
15816 cubic millimeters (mm^3)
Standard Deviation 14274
|
SECONDARY outcome
Timeframe: At the end of active double-blind phase or termination/early termination visit (up to Week 36)Population: ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.
Inflammatory disease activity was assessed by MRI measurement of the number of new hypointense T1 lesions.
Outcome measures
| Measure |
Double-Blind: Laquinimod 0.3 mg
n=66 Participants
Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
n=82 Participants
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
n=36 Participants
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
n=38 Participants
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
|---|---|---|---|---|
|
Double-Blind Period: Number of New Hypointense T1 Lesion on Enhanced T1 Scans
|
1.23 lesions
Standard Deviation 2.69
|
0.70 lesions
Standard Deviation 2.01
|
1.11 lesions
Standard Deviation 2.11
|
1.24 lesions
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: At the end of active double-blind phase or termination/early termination visit (up to Week 36)Population: ITT analysis set included all participants who entered in extension study LAQ/5063 (after completion of the entire treatment period in LAQ/5062) and received at least one dose of laquinimod (either 0.3 mg or 0.6 mg) during the active double-blind phase. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure.
EDSS (developed by John F. Kurtzke) is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel and bladder, cerebral, and other functions). Each functional system score and an overall score ranges from 0 to 10, where 0 = Normal; 1-1.5 = No disability, but some abnormal neurological signs; 2-2.5 = Minimal disability; 3-4.5 = Moderate disability, affecting daily activities, but can still walk; 5-8 = More severe disability, impairing daily activities and requiring assistance with walking; 8.5-9.5 = Very severe disability, restricting to bed; 10 = Death due to MS. A lower score indicated less disability.
Outcome measures
| Measure |
Double-Blind: Laquinimod 0.3 mg
n=78 Participants
Participants who were receiving laquinimod 0.3 mg tablet once daily orally in double-blind core study, were continued to receive laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg
n=92 Participants
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally in double-blind core study, were continued to receive laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.3 mg
n=39 Participants
Participants who were receiving placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Placebo/Laquinimod 0.6 mg
n=43 Participants
Participants who were receiving placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
|---|---|---|---|---|
|
Double-Blind Period: Kurtzke's Expanded Disability Status Scale (EDSS) Score
|
2.53 units on a scale
Standard Deviation 1.60
|
2.44 units on a scale
Standard Deviation 1.21
|
2.51 units on a scale
Standard Deviation 1.40
|
2.27 units on a scale
Standard Deviation 1.35
|
Adverse Events
Double-Blind: Laquinimod 0.3 mg/Placebo to Laquinimod 0.3 mg
Serious events: 6 serious events
Other events: 68 other events
Deaths: 0 deaths
Double-Blind: Laquinimod 0.6 mg/Placebo to Laquinimod 0.6 mg
Serious events: 6 serious events
Other events: 74 other events
Deaths: 0 deaths
Open Label: Laquinimod 0.6 mg
Serious events: 30 serious events
Other events: 95 other events
Deaths: 2 deaths
Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg
Serious events: 19 serious events
Other events: 82 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-Blind: Laquinimod 0.3 mg/Placebo to Laquinimod 0.3 mg
n=119 participants at risk
Participants who were receiving either laquinimod 0.3 mg or placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg/Placebo to Laquinimod 0.6 mg
n=138 participants at risk
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) or placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Open Label: Laquinimod 0.6 mg
n=113 participants at risk
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
|
Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg
n=96 participants at risk
Participants who were receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
General disorders
Gait disturbance
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
General disorders
Oedema peripheral
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.8%
2/113 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.1%
2/96 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Endometritis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Salpingo-oophoritis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Investigations
Borrelia test positive
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Investigations
Cardiovascular evaluation
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Investigations
HIV test positive
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.8%
2/113 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Surgical and medical procedures
Cervical conisation
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Surgical and medical procedures
Meniscus operation
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Surgical and medical procedures
Tricuspid valve repair
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Surgical and medical procedures
Uterine dilation and curettage
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Sepsis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Subacute endocarditis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Investigations
Weight decreased
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/113 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
Other adverse events
| Measure |
Double-Blind: Laquinimod 0.3 mg/Placebo to Laquinimod 0.3 mg
n=119 participants at risk
Participants who were receiving either laquinimod 0.3 mg or placebo matched to laquinimod 0.3 mg tablet once daily orally in double-blind core study, received laquinimod 0.3 mg tablet once daily orally in double-blind extension period of this study for up to Week 36.
|
Double-Blind: Laquinimod 0.6 mg/Placebo to Laquinimod 0.6 mg
n=138 participants at risk
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) or placebo matched to laquinimod 0.6 mg (2 tablets of placebo) once daily orally in double-blind core study, received laquinimod 0.6 mg once daily orally in double-blind extension period of this study for up to Week 36.
|
Open Label: Laquinimod 0.6 mg
n=113 participants at risk
Participants who were receiving laquinimod 0.6 mg (2 tablets of 0.3 mg each) once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
|
Open-Label: Laquinimod 0.3 mg/Laquinimod 0.6 mg
n=96 participants at risk
Participants who were receiving laquinimod 0.3 mg tablet once daily orally either in double-blind core study or double-blind extension period, received laquinimod 0.6 mg capsule once daily orally in open-label extension period of this study until termination (as long as the Sponsor continued the development of laquinimod 0.6 mg for RRMS) or early discontinuation (up to approximately 10.5 years).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
2/119 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.3%
6/113 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
4.2%
4/96 • Number of events 7 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
6.2%
7/113 • Number of events 8 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
8.3%
8/96 • Number of events 13 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Cardiac disorders
Tachycardia
|
2.5%
3/119 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
4.3%
6/138 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
3.5%
4/113 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
9.7%
11/113 • Number of events 13 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
3.6%
5/138 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
6.2%
7/113 • Number of events 9 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.1%
2/96 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
2/119 • Number of events 4 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.2%
3/138 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
3.5%
4/113 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
8.3%
8/96 • Number of events 10 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
2/119 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.8%
2/113 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Gastrointestinal disorders
Toothache
|
1.7%
2/119 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.3%
6/113 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.1%
2/96 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/119 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.7%
3/113 • Number of events 4 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
General disorders
Asthenia
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
4.4%
5/113 • Number of events 8 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
6.2%
6/96 • Number of events 8 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
General disorders
Fatigue
|
2.5%
3/119 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.9%
4/138 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
10.6%
12/113 • Number of events 15 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.1%
2/96 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
General disorders
Pyrexia
|
0.84%
1/119 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.9%
4/138 • Number of events 4 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.3%
6/113 • Number of events 15 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Immune system disorders
Seasonal allergy
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Bronchitis
|
2.5%
3/119 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
8.8%
10/113 • Number of events 13 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
11.5%
11/96 • Number of events 14 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Cystitis
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
7.1%
8/113 • Number of events 21 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
6.2%
6/96 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Influenza
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
7.1%
8/113 • Number of events 9 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
8.3%
8/96 • Number of events 9 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Nasopharyngitis
|
15.1%
18/119 • Number of events 25 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
16.7%
23/138 • Number of events 30 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
33.6%
38/113 • Number of events 96 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
40.6%
39/96 • Number of events 80 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Oral herpes
|
2.5%
3/119 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
6.2%
7/113 • Number of events 15 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
7.3%
7/96 • Number of events 9 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Pharyngitis
|
4.2%
5/119 • Number of events 8 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.2%
3/138 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
10.6%
12/113 • Number of events 18 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
10.4%
10/96 • Number of events 21 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
8.8%
10/113 • Number of events 15 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
10.4%
10/96 • Number of events 15 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Rhinitis
|
1.7%
2/119 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.9%
4/138 • Number of events 4 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
6.2%
7/113 • Number of events 8 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
11.5%
11/96 • Number of events 14 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Tonsillitis
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.3%
6/113 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
8.3%
8/96 • Number of events 15 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.2%
5/119 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.2%
3/138 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
10.6%
12/113 • Number of events 22 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
14.6%
14/96 • Number of events 33 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Urinary tract infection
|
5.0%
6/119 • Number of events 8 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.2%
3/138 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
8.0%
9/113 • Number of events 11 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
8.3%
8/96 • Number of events 15 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Viral infection
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.8%
2/113 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
8.0%
9/113 • Number of events 9 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.3%
6/113 • Number of events 8 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.3%
6/113 • Number of events 8 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Investigations
Blood fibrinogen increased
|
2.5%
3/119 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
4.3%
6/138 • Number of events 7 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
6.2%
7/113 • Number of events 7 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Investigations
C-reactive protein increased
|
2.5%
3/119 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
7.1%
8/113 • Number of events 10 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Investigations
Haematocrit decreased
|
1.7%
2/119 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.7%
3/113 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 7 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Investigations
Neutrophil count increased
|
2.5%
3/119 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.3%
6/113 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.1%
2/96 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Investigations
White blood cell count increased
|
2.5%
3/119 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.2%
3/138 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.3%
6/113 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
3.1%
3/96 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
4.4%
5/113 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
6.2%
6/96 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
5/119 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.2%
3/138 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
15.0%
17/113 • Number of events 22 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
10.4%
10/96 • Number of events 18 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
4/119 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
8.7%
12/138 • Number of events 15 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
27.4%
31/113 • Number of events 54 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
22.9%
22/96 • Number of events 32 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
6.2%
7/113 • Number of events 7 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.1%
2/96 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
6.2%
7/113 • Number of events 9 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.1%
2/96 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.4%
4/119 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
3.5%
4/113 • Number of events 4 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.7%
3/113 • Number of events 3 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
6.2%
6/96 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Nervous system disorders
Dizziness
|
5.0%
6/119 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
3.6%
5/138 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
4.2%
4/96 • Number of events 4 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Nervous system disorders
Headache
|
13.4%
16/119 • Number of events 19 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
11.6%
16/138 • Number of events 20 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
15.0%
17/113 • Number of events 23 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
21.9%
21/96 • Number of events 29 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 7 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Psychiatric disorders
Depression
|
1.7%
2/119 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
9.7%
11/113 • Number of events 16 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
9.4%
9/96 • Number of events 10 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.88%
1/113 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 7 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
4.4%
5/113 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
2/119 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
4.3%
6/138 • Number of events 7 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
3.5%
4/113 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Vascular disorders
Hypertension
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.72%
1/138 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
4.4%
5/113 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
7.3%
7/96 • Number of events 9 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.8%
2/113 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Furuncle
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.3%
6/113 • Number of events 9 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.1%
2/96 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.4%
2/138 • Number of events 2 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
6.2%
7/113 • Number of events 9 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
4.2%
4/96 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.3%
6/113 • Number of events 6 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
1.0%
1/96 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Psychiatric disorders
Insomnia
|
0.84%
1/119 • Number of events 1 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
4.4%
5/113 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/119 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
0.00%
0/138 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
2.7%
3/113 • Number of events 4 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
5.2%
5/96 • Number of events 5 • Double-Blind (DB) Extension Period (Week 0 to Week 36):defined for DB treatment as start and end dates of events provided in clinical study database. Open-Label (OL) Extension Period (Month 0/termination of DB extension phase [completion of full 36 weeks] until termination [as long as Sponsor continued development of laquinimod 0.6 mg for RRMS] or early discontinuation [up to approximately 10.5 years]):defined for OL treatment as start and end dates of events provided in clinical study database.
AEs that occurred after the DB end date and before OL start date are reported only once in the DB phase. AEs that occurred after the DB end date for participants who did not switch to the OL treatment are reported only once in the DB phase.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc
Phone: 215-591-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER