Trial Outcomes & Findings for A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis (NCT NCT01047319)
NCT ID: NCT01047319
Last Updated: 2021-12-09
Results Overview
A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. TEAEs associated with cancer, ischemic heart disease, cerebrovascular events, and arthritis were considered to be of special interest.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1047 participants
Primary outcome timeframe
Day 1 up to 7.13 years
Results posted on
2021-12-09
Participant Flow
All participants who completed the full duration of the double-blind BRAVO study (study MS-LAQ-302) were eligible to enter into Study MS-LAQ-302E. Of the 1090 participants who completed MS-LAQ-302, 1047 opted to continue into the open-label extension study.
1047 subjects with RRMS were enrolled to receive laquinimod 0.6 mg daily at 144 study sites in 18 countries by 144 investigators.
Participant milestones
| Measure |
Early Laquinimod
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.
|
Switch From Avonex
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
345
|
350
|
352
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
345
|
350
|
352
|
Reasons for withdrawal
| Measure |
Early Laquinimod
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.
|
Switch From Avonex
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
|
|---|---|---|---|
|
Overall Study
Teva requested participant withdrawal
|
3
|
0
|
1
|
|
Overall Study
Protocol Violation
|
3
|
2
|
4
|
|
Overall Study
Lack of Efficacy
|
4
|
3
|
3
|
|
Overall Study
Death
|
5
|
1
|
5
|
|
Overall Study
Pregnancy
|
13
|
8
|
8
|
|
Overall Study
Physician Decision
|
12
|
9
|
10
|
|
Overall Study
Lost to Follow-up
|
14
|
10
|
10
|
|
Overall Study
Adverse Event
|
16
|
27
|
21
|
|
Overall Study
Withdrawal by Subject
|
77
|
75
|
87
|
|
Overall Study
Study terminated by Sponsor
|
198
|
215
|
203
|
Baseline Characteristics
A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Early Laquinimod
n=345 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=350 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.
|
Switch From Avonex
n=352 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
|
Total
n=1047 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 9.16 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 9.23 • n=7 Participants
|
40.1 years
STANDARD_DEVIATION 9.34 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 9.24 • n=4 Participants
|
|
Sex: Female, Male
Female
|
228 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
234 Participants
n=5 Participants
|
707 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
340 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian/Oriental
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
338 Participants
n=5 Participants
|
346 Participants
n=7 Participants
|
348 Participants
n=5 Participants
|
1032 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 7.13 yearsPopulation: Safety
A treatment-emergent adverse event was defined as any untoward medical occurrence that develops or worsens in severity following start of treatment and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs (SAE) include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. TEAEs associated with cancer, ischemic heart disease, cerebrovascular events, and arthritis were considered to be of special interest.
Outcome measures
| Measure |
Early Laquinimod
n=345 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=350 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.
|
Switch From Avonex
n=352 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
|
|---|---|---|---|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 TEAE
|
290 Participants
|
303 Participants
|
279 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 Serious TEAE
|
54 Participants
|
65 Participants
|
51 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 Severe TEAE
|
36 Participants
|
54 Participants
|
44 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 TEAE causing discontinuation
|
20 Participants
|
28 Participants
|
23 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 TEAE of special interest
|
66 Participants
|
64 Participants
|
73 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 treatment-related TEAE
|
66 Participants
|
76 Participants
|
96 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 TEAE leading to death
|
5 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0 for extension), Day 1 up to 7.13 yearsPopulation: Safety analysis set of participants with a baseline and post-baseline value for that vital sign,
Vital signs with potentially clinically significant abnormal results were evaluated using the following significance criteria: * Pulse rate: \>=120 and increase \>=30 beats/minute * Systolic blood pressure low: \<=90 and decrease \>=30 mmHg * Systolic blood pressure high: \>=180 and increase \>=30 mmHg * Diastolic blood pressure low: \<=50 and decrease \>=20 mmHg * Diastolic blood pressure high: \>=100 and increase \>=20 mmHg Note that the change is compared to baseline,
Outcome measures
| Measure |
Early Laquinimod
n=345 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=350 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.
|
Switch From Avonex
n=352 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
|
|---|---|---|---|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs
Diastolic blood pressure - low
|
4 Participants
|
5 Participants
|
4 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs
Participants with at least one abnormality
|
19 Participants
|
23 Participants
|
19 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs
Pulse rate - high
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs
Systolic blood pressure - low
|
4 Participants
|
7 Participants
|
9 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs
Systolic blood pressure - high
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs
Diastolic blood pressure - high
|
9 Participants
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 1 to 7.13 yearsPopulation: Safety analysis set of participants with both a baseline and a post-baseline value for the test.
Counts include two conditions: * a change from High / Non-PCS at baseline to Low PCS at any point during the study * a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non-PCS value are included in the population count. ALT=alanine aminotransferase ALP=alkaline phosphatase P-amylase=amylase, pancreatic AST=aspartate aminotransferase CRP=C reactive protein CK=creatine kinase CTN=creatinine FIB=fibrinogen GGT=gamma glutamyl transferase K=potassium
Outcome measures
| Measure |
Early Laquinimod
n=344 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=349 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.
|
Switch From Avonex
n=347 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
|
|---|---|---|---|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
ALT - change from Low / Non-PCS to High PCS
|
5 Participants
|
8 Participants
|
10 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Albumen - change from High / Non-PCS to Low PCS
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
ALP - change from Low / Non-PCS to High PCS
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
p-Amylase - change from Low / Non-PCS to High PCS
|
5 Participants
|
1 Participants
|
2 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
AST - change from Low / Non-PCS to High PCS
|
3 Participants
|
2 Participants
|
5 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Bilirubin - change from Low / Non-PCS to High PCS
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
CRP - change from Low / Non-PCS to High PCS
|
36 Participants
|
32 Participants
|
31 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Calcium - change from High / Non-PCS to Low PCS
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Calcium - change from Low / Non-PCS to High PCS
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
CK - change from Low / Non-PCS to High PCS
|
11 Participants
|
12 Participants
|
10 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
CTN - change from Low / Non-PCS to High PCS
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
FIB - change from Low / Non-PCS to High PCS
|
22 Participants
|
24 Participants
|
25 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
GGT - change from Low / Non-PCS to High PCS
|
16 Participants
|
22 Participants
|
18 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Glucose - change from High / Non-PCS to Low PCS
|
12 Participants
|
16 Participants
|
11 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Glucose - change from Low / Non-PCS to High PCS
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Phosphate-change from High / Non-PCS to Low PCS
|
12 Participants
|
12 Participants
|
6 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Phosphate-change from Low / Non-PCS to High PCS
|
17 Participants
|
18 Participants
|
16 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
K - change from High / Non-PCS to Low PCS
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
K - change from Low / Non-PCS to High PCS
|
46 Participants
|
39 Participants
|
38 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Sodium - change from High / Non-PCS to Low PCS
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Sodium - change from Low / Non-PCS to High PCS
|
21 Participants
|
16 Participants
|
17 Participants
|
|
Participants With Serum Chemistry Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Urea - change from Low / Non-PCS to High PCS
|
4 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 1 to 7.13 yearsPopulation: Safety analysis set of participants with both a baseline and a post-baseline value for the test.
Counts include two conditions: * a change from High / Non-PCS at baseline to Low PCS at any point during the study * a change from Low / Non-PCS at baseline to High PCS at any point during the study Participants whose condition was not changed from baseline or was changed to a non-PCS value are included in the population count.
Outcome measures
| Measure |
Early Laquinimod
n=344 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=349 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.
|
Switch From Avonex
n=347 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
|
|---|---|---|---|
|
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Hematocrit - change from High / Non-PCS to Low PCS
|
30 Participants
|
25 Participants
|
21 Participants
|
|
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Hemoglobin -change from High / Non-PCS to Low PCS
|
21 Participants
|
24 Participants
|
15 Participants
|
|
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Leukocytes - change from High / Non-PCS to Low PCS
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Leukocytes - change from Low / Non-PCS to High PCS
|
4 Participants
|
1 Participants
|
5 Participants
|
|
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Neutrophils - change from High/Non-PCS to Low PCS
|
25 Participants
|
12 Participants
|
14 Participants
|
|
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Platelets - change from High / Non-PCS to Low PCS
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Participants With Serum Hematology Laboratory Tests That Were Potentially Clinically Significant (PCS) Abnormal Comparing Baseline to Any Time During the Study
Platelets - change from Low / Non-PCS to High PCS
|
4 Participants
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0), Day 1 to 7.13 yearsPopulation: Safety analysis set of participants with both a baseline and a post-baseline ECG.
Shifts are presented as Baseline finding / Worse finding at anytime during the study. Categories for findings are: * normal * abnormal, not clinically significant (Not CS) * abnormal, clinically significant (CS)
Outcome measures
| Measure |
Early Laquinimod
n=340 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=346 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.
|
Switch From Avonex
n=345 Participants
All participants in MS-LAQ-302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
|
|---|---|---|---|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Normal / Normal
|
150 Participants
|
148 Participants
|
134 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Normal / Abnormal, Not CS
|
109 Participants
|
125 Participants
|
119 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Normal / Abnormal, CS
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Abnormal, Not CS / Normal
|
5 Participants
|
7 Participants
|
20 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Abnormal, Not CS / Abnormal, Not CS
|
67 Participants
|
62 Participants
|
64 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Abnormal, Not CS / Abnormal, CS
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Abnormal, CS / Normal
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Abnormal, CS / Abnormal, Not CS
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Abnormal, CS / Abnormal, CS
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Early Laquinimod
Serious events: 54 serious events
Other events: 215 other events
Deaths: 5 deaths
Switch From Placebo
Serious events: 65 serious events
Other events: 205 other events
Deaths: 3 deaths
Switch From Avonex
Serious events: 51 serious events
Other events: 194 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Early Laquinimod
n=345 participants at risk
All participants in MS-LAQ- 302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=350 participants at risk
All participants in MS-LAQ- 302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from Placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.
|
Switch From Avonex
n=352 participants at risk
All participants in MS-LAQ- 302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
|
|---|---|---|---|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.58%
2/345 • Number of events 2 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.57%
2/352 • Number of events 2 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Cardiac failure
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Cardiac failure congestive
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Coronary artery dissection
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.85%
3/352 • Number of events 3 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Cardiac disorders
Ventricular fibrillation
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Endocrine disorders
Adrenal mass
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Endocrine disorders
Goitre
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Eye disorders
Blepharitis
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Eye disorders
Cataract nuclear
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 2 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
General disorders
Pyrexia
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Immune system disorders
Allergy to metals
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Immune system disorders
Food allergy
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Infections and infestations
Acute hepatitis C
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Appendicitis
|
0.58%
2/345 • Number of events 2 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Infections and infestations
Bronchitis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Infections and infestations
Carbuncle
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Cellulitis
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Chorioretinitis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Infections and infestations
Cystitis
|
0.58%
2/345 • Number of events 2 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Infections and infestations
HIV infection
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Herpes zoster
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Incision site abscess
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Lung abscess
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Infections and infestations
Orchitis
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Peritonitis
|
0.58%
2/345 • Number of events 2 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.57%
2/352 • Number of events 2 • Day 1 up to 7.13 years
|
|
Infections and infestations
Pneumonia
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.57%
2/352 • Number of events 2 • Day 1 up to 7.13 years
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.57%
2/352 • Number of events 2 • Day 1 up to 7.13 years
|
|
Infections and infestations
Pyelonephritis
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Salpingo-oophoritis
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.57%
2/352 • Number of events 2 • Day 1 up to 7.13 years
|
|
Infections and infestations
Urinary tract infection
|
0.87%
3/345 • Number of events 3 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.57%
2/352 • Number of events 2 • Day 1 up to 7.13 years
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Concussion
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Contusion
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Epiphyseal fracture
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.57%
2/350 • Number of events 2 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.57%
2/350 • Number of events 2 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Ureteric injury
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Injury, poisoning and procedural complications
Wound
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Investigations
Hepatic enzyme increased
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.58%
2/345 • Number of events 2 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.58%
2/345 • Number of events 2 • Day 1 up to 7.13 years
|
0.57%
2/350 • Number of events 2 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage II
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.57%
2/350 • Number of events 2 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroma
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.57%
2/350 • Number of events 2 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.87%
3/345 • Number of events 4 • Day 1 up to 7.13 years
|
1.1%
4/350 • Number of events 4 • Day 1 up to 7.13 years
|
0.85%
3/352 • Number of events 3 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Altered state of consciousness
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Epilepsy
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 2 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.57%
2/350 • Number of events 2 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Muscle spasticity
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Sciatica
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 2 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.86%
3/350 • Number of events 3 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Product Issues
Device loosening
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Psychiatric disorders
Completed suicide
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Psychiatric disorders
Mood disorder due to a general medical condition
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Renal and urinary disorders
Calculus urinary
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Renal and urinary disorders
Crush syndrome
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Renal and urinary disorders
Hydronephrosis
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Renal and urinary disorders
Micturition disorder
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 4 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Reproductive system and breast disorders
Bartholin's cyst
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.86%
3/350 • Number of events 3 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Reproductive system and breast disorders
Cervix disorder
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
1.1%
4/350 • Number of events 5 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.57%
2/350 • Number of events 2 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Reproductive system and breast disorders
Ovarian haemorrhage
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Reproductive system and breast disorders
Pelvic adhesions
|
0.29%
1/345 • Number of events 2 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Reproductive system and breast disorders
Vaginal cyst
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Surgical and medical procedures
Bartholin's cyst removal
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Surgical and medical procedures
Fracture reduction
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Surgical and medical procedures
Osteosynthesis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Surgical and medical procedures
Radical hysterectomy
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Surgical and medical procedures
Skin lesion excision
|
0.29%
1/345 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Surgical and medical procedures
Splenectomy
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.57%
2/352 • Number of events 2 • Day 1 up to 7.13 years
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Vascular disorders
Internal haemorrhage
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.29%
1/350 • Number of events 1 • Day 1 up to 7.13 years
|
0.00%
0/352 • Day 1 up to 7.13 years
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/345 • Day 1 up to 7.13 years
|
0.00%
0/350 • Day 1 up to 7.13 years
|
0.28%
1/352 • Number of events 1 • Day 1 up to 7.13 years
|
Other adverse events
| Measure |
Early Laquinimod
n=345 participants at risk
All participants in MS-LAQ- 302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Early laquinimod subgroup included participants in MS-LAQ-302 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=350 participants at risk
All participants in MS-LAQ- 302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped.
The Switch from Placebo subgroup included participants in MS-LAQ-302 double-blind study who were administered placebo daily for 24 months.
|
Switch From Avonex
n=352 participants at risk
All participants in MS-LAQ- 302E were administered 1 capsule containing laquinimod 0.6 mg taken orally at the same hour every day until the product was commercially available or development stopped. The Switch from Avonex subgroup included participants in MS-LAQ-302 rater-blind study who were administered Avonex 30 mcg IM once weekly for 24 months.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.4%
22/345 • Number of events 34 • Day 1 up to 7.13 years
|
5.7%
20/350 • Number of events 24 • Day 1 up to 7.13 years
|
4.3%
15/352 • Number of events 18 • Day 1 up to 7.13 years
|
|
Infections and infestations
Bronchitis
|
7.0%
24/345 • Number of events 26 • Day 1 up to 7.13 years
|
6.6%
23/350 • Number of events 29 • Day 1 up to 7.13 years
|
4.5%
16/352 • Number of events 27 • Day 1 up to 7.13 years
|
|
Infections and infestations
Influenza
|
7.8%
27/345 • Number of events 34 • Day 1 up to 7.13 years
|
7.1%
25/350 • Number of events 38 • Day 1 up to 7.13 years
|
6.2%
22/352 • Number of events 32 • Day 1 up to 7.13 years
|
|
Infections and infestations
Nasopharyngitis
|
15.1%
52/345 • Number of events 96 • Day 1 up to 7.13 years
|
13.1%
46/350 • Number of events 77 • Day 1 up to 7.13 years
|
10.5%
37/352 • Number of events 58 • Day 1 up to 7.13 years
|
|
Infections and infestations
Pharyngitis
|
3.2%
11/345 • Number of events 18 • Day 1 up to 7.13 years
|
5.1%
18/350 • Number of events 24 • Day 1 up to 7.13 years
|
3.1%
11/352 • Number of events 15 • Day 1 up to 7.13 years
|
|
Infections and infestations
Respiratory tract infection viral
|
5.8%
20/345 • Number of events 25 • Day 1 up to 7.13 years
|
4.3%
15/350 • Number of events 24 • Day 1 up to 7.13 years
|
4.5%
16/352 • Number of events 20 • Day 1 up to 7.13 years
|
|
Infections and infestations
Upper respiratory tract infection
|
10.4%
36/345 • Number of events 62 • Day 1 up to 7.13 years
|
10.3%
36/350 • Number of events 63 • Day 1 up to 7.13 years
|
8.0%
28/352 • Number of events 59 • Day 1 up to 7.13 years
|
|
Infections and infestations
Urinary tract infection
|
6.4%
22/345 • Number of events 30 • Day 1 up to 7.13 years
|
5.1%
18/350 • Number of events 22 • Day 1 up to 7.13 years
|
4.8%
17/352 • Number of events 22 • Day 1 up to 7.13 years
|
|
Investigations
C-reactive protein increased
|
5.5%
19/345 • Number of events 25 • Day 1 up to 7.13 years
|
4.9%
17/350 • Number of events 23 • Day 1 up to 7.13 years
|
4.0%
14/352 • Number of events 16 • Day 1 up to 7.13 years
|
|
Investigations
Weight increased
|
5.5%
19/345 • Number of events 23 • Day 1 up to 7.13 years
|
3.1%
11/350 • Number of events 11 • Day 1 up to 7.13 years
|
2.6%
9/352 • Number of events 10 • Day 1 up to 7.13 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
21/345 • Number of events 27 • Day 1 up to 7.13 years
|
6.6%
23/350 • Number of events 27 • Day 1 up to 7.13 years
|
8.0%
28/352 • Number of events 38 • Day 1 up to 7.13 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.2%
49/345 • Number of events 74 • Day 1 up to 7.13 years
|
14.0%
49/350 • Number of events 72 • Day 1 up to 7.13 years
|
14.2%
50/352 • Number of events 73 • Day 1 up to 7.13 years
|
|
Nervous system disorders
Headache
|
12.8%
44/345 • Number of events 84 • Day 1 up to 7.13 years
|
17.1%
60/350 • Number of events 121 • Day 1 up to 7.13 years
|
21.0%
74/352 • Number of events 128 • Day 1 up to 7.13 years
|
|
Psychiatric disorders
Depression
|
7.5%
26/345 • Number of events 26 • Day 1 up to 7.13 years
|
5.7%
20/350 • Number of events 21 • Day 1 up to 7.13 years
|
4.8%
17/352 • Number of events 21 • Day 1 up to 7.13 years
|
|
Vascular disorders
Hypertension
|
5.2%
18/345 • Number of events 22 • Day 1 up to 7.13 years
|
6.0%
21/350 • Number of events 23 • Day 1 up to 7.13 years
|
5.1%
18/352 • Number of events 18 • Day 1 up to 7.13 years
|
Additional Information
Director, Clinical Research
Teva Pharmaceutical Industries, Ltd
Phone: 1-888-483-8279
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