Trial Outcomes & Findings for A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course (NCT NCT00988052)
NCT ID: NCT00988052
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
839 participants
Primary outcome timeframe
Day 1 up to 7.64 years
Results posted on
2021-12-09
Participant Flow
In the preceding double-blind, placebo-controlled ALLEGRO study (study MS-LAQ-301), 1106 subjects with RRMS were randomized to treatment, and 864 subjects completed the study according to the protocol (ie, by completing the ALLEGRO study termination visit procedures).
In this open-label extension study, 839 subjects with RRMS were enrolled to receive laquinimod 0.6 mg at 135 study sites in 22 countries by 135 investigators.
Participant milestones
| Measure |
Early Laquinimod
All participants in MS-LAQ-301E 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-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
All participants in MS-LAQ-301E 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-301 double-blind study who were administered placebo daily for 24 months.
|
|---|---|---|
|
Overall Study
STARTED
|
423
|
416
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
423
|
416
|
Reasons for withdrawal
| Measure |
Early Laquinimod
All participants in MS-LAQ-301E 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-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
All participants in MS-LAQ-301E 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-301 double-blind study who were administered placebo daily for 24 months.
|
|---|---|---|
|
Overall Study
Missing
|
1
|
0
|
|
Overall Study
Teva requested subject withdrawal
|
3
|
1
|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Protocol Violation
|
6
|
5
|
|
Overall Study
Pregnancy
|
6
|
6
|
|
Overall Study
Lack of Efficacy
|
8
|
7
|
|
Overall Study
Lost to Follow-up
|
6
|
11
|
|
Overall Study
Physician Decision
|
27
|
28
|
|
Overall Study
Adverse Event
|
35
|
28
|
|
Overall Study
Withdrawal by Subject
|
90
|
91
|
|
Overall Study
Study terminated by sponsor
|
240
|
236
|
Baseline Characteristics
A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course
Baseline characteristics by cohort
| Measure |
Early Laquinimod
n=423 Participants
All participants in MS-LAQ-301E 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-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=416 Participants
All participants in MS-LAQ-301E 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-301 double-blind study who were administered placebo daily for 24 months.
|
Total
n=839 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.1 years
STANDARD_DEVIATION 9.10 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 9.14 • n=7 Participants
|
40.8 years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
298 Participants
n=5 Participants
|
271 Participants
n=7 Participants
|
569 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian / Oriental
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black / African American
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
414 Participants
n=5 Participants
|
401 Participants
n=7 Participants
|
815 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 7.64 yearsPopulation: Safety analysis set
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=423 Participants
All participants in MS-LAQ-301E 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-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=416 Participants
All participants in MS-LAQ-301E 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-301 double-blind study who were administered placebo daily for 24 months.
|
|---|---|---|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 TEAE causing discontinuation
|
35 Participants
|
32 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 TEAE
|
375 Participants
|
374 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 Severe TEAE
|
76 Participants
|
69 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 TEAE of special interest
|
109 Participants
|
105 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 treatment-related TEAE
|
139 Participants
|
153 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 TEAE leading to death
|
3 Participants
|
3 Participants
|
|
Participants With Treatment-Emergent Adverse Events (TEAEs)
=>1 Serious TEAE
|
108 Participants
|
92 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to 7.64 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 low: \<=45 and decrease \>=30 beats/minute * Pulse rate high: \>=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
Outcome measures
| Measure |
Early Laquinimod
n=423 Participants
All participants in MS-LAQ-301E 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-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=416 Participants
All participants in MS-LAQ-301E 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-301 double-blind study who were administered placebo daily for 24 months.
|
|---|---|---|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs
Participants with at least one abnormality
|
36 Participants
|
34 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs
Pulse rate - low
|
1 Participants
|
1 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs
Diastolic blood pressure - low
|
7 Participants
|
7 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs
Pulse rate - high
|
2 Participants
|
1 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs
Systolic blood pressure - low
|
20 Participants
|
10 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs
Systolic blood pressure - high
|
1 Participants
|
2 Participants
|
|
Participants With Potentially Clinically Significant Abnormal Vital Signs
Diastolic blood pressure - high
|
8 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to 7.64 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=422 Participants
All participants in MS-LAQ-301E 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-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=415 Participants
All participants in MS-LAQ-301E 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-301 double-blind study who were administered placebo daily for 24 months.
|
|---|---|---|
|
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
|
14 Participants
|
15 Participants
|
|
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
|
8 Participants
|
14 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
|
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
|
3 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
|
2 Participants
|
6 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
|
4 Participants
|
5 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
|
41 Participants
|
51 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
|
4 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
|
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
|
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
CTN - change from Low / Non- PCS to High PCS
|
2 Participants
|
2 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
|
37 Participants
|
38 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
|
33 Participants
|
24 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
|
23 Participants
|
27 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
|
9 Participants
|
5 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
|
19 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
|
4 Participants
|
3 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
|
55 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
|
8 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
|
13 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
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to 7.64 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=422 Participants
All participants in MS-LAQ-301E 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-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=415 Participants
All participants in MS-LAQ-301E 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-301 double-blind study who were administered placebo daily 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
|
36 Participants
|
29 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
|
27 Participants
|
22 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 Low / Non-PCS to High PCS
|
0 Participants
|
1 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
|
1 Participants
|
1 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
|
3 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
|
15 Participants
|
12 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
|
4 Participants
|
7 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
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to 7.64 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=420 Participants
All participants in MS-LAQ-301E 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-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo
n=412 Participants
All participants in MS-LAQ-301E 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-301 double-blind study who were administered placebo daily for 24 months.
|
|---|---|---|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Abnormal, Not CS / Abnormal, Not CS
|
70 Participants
|
67 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Abnormal, Not CS / Abnormal, CS
|
2 Participants
|
4 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Abnormal, CS / Normal
|
0 Participants
|
0 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Abnormal, CS / Abnormal, CS
|
0 Participants
|
0 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Normal / Normal
|
189 Participants
|
198 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Normal / Abnormal, Not CS
|
145 Participants
|
126 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Normal / Abnormal, CS
|
2 Participants
|
3 Participants
|
|
Participants With Electrocardiogram (ECG) Fiindings That Shifted From Baseline to Any Time During the Study
Abnormal, Not CS / Normal
|
12 Participants
|
14 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
|
Adverse Events
Early Laquinimod 0.6 mg
Serious events: 108 serious events
Other events: 299 other events
Deaths: 3 deaths
Switch From Placebo to Laquinimod 0.6 mg
Serious events: 92 serious events
Other events: 300 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Early Laquinimod 0.6 mg
n=423 participants at risk
All participants in MS-LAQ-301E 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-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo to Laquinimod 0.6 mg
n=416 participants at risk
All participants in MS-LAQ-301E 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-301 double-blind study who were administered placebo daily for 24 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Blood and lymphatic system disorders
Bone marrow oedema
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Acute coronary syndrome
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Angina pectoris
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Angina unstable
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.48%
2/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.47%
2/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Cardiac failure chronic
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Cardiac failure congestive
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Mitral valve incompetence
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Myocardial infarction
|
0.47%
2/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.48%
2/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Myocardial ischaemia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Pericarditis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Ear and labyrinth disorders
Deafness
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Endocrine disorders
Goitre
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Endocrine disorders
Parathyroid gland enlargement
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Eye disorders
Eye haemorrhage
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Eye disorders
Uveitis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Gastritis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.48%
2/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.47%
2/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Omental infarction
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
General disorders
Asthenia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
General disorders
Chest discomfort
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
General disorders
Chest pain
|
0.47%
2/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
General disorders
Death
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
General disorders
Drowning
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
General disorders
Fatigue
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
General disorders
Gait disturbance
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
General disorders
Impaired healing
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
General disorders
Inflammation
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
General disorders
Influenza like illness
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
General disorders
Medical device pain
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
General disorders
Pyrexia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
General disorders
Systemic inflammatory response syndrome
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Hepatobiliary disorders
Biliary colic
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.47%
2/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Hepatobiliary disorders
Hepatitis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Immune system disorders
Drug hypersensitivity
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Abscess limb
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Acute sinusitis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Appendicitis
|
0.95%
4/423 • Number of events 4 • Day 1 up to 7.64 years
|
0.72%
3/416 • Number of events 3 • Day 1 up to 7.64 years
|
|
Infections and infestations
Appendicitis perforated
|
0.47%
2/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Bartholin's abscess
|
0.24%
1/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Breast abscess
|
0.24%
1/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Cellulitis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Cholecystitis infective
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Chronic tonsillitis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Furuncle
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Groin abscess
|
0.47%
2/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Hepatic echinococciasis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Infections and infestations
Influenza
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Latent syphilis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Latent tuberculosis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Infections and infestations
Mycotoxicosis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Otitis media chronic
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Ovarian abscess
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Peritonitis
|
0.95%
4/423 • Number of events 4 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Periumbilical abscess
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Pertussis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Pilonidal cyst
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Pneumonia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.72%
3/416 • Number of events 4 • Day 1 up to 7.64 years
|
|
Infections and infestations
Postoperative wound infection
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Pyelonephritis acute
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Salpingo-oophoritis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Staphylococcal infection
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Subcutaneous abscess
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Urinary tract infection
|
0.47%
2/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Infections and infestations
Urosepsis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
6/423 • Number of events 6 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.47%
2/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.48%
2/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Seroma
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Investigations
C-reactive protein increased
|
0.95%
4/423 • Number of events 4 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Investigations
Hepatic enzyme increased
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.24%
1/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Metabolism and nutrition disorders
Obesity
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.47%
2/423 • Number of events 3 • Day 1 up to 7.64 years
|
0.72%
3/416 • Number of events 3 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Joint hyperextension
|
0.24%
1/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.47%
2/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Knee impingement syndrome
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.48%
2/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.24%
1/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.24%
1/423 • Number of events 3 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Tendon calcification
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.47%
2/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia stage 1
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Langerhans' cell histiocytosis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.24%
1/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.24%
1/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncocytoma
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tubular breast carcinoma
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.71%
3/423 • Number of events 3 • Day 1 up to 7.64 years
|
0.96%
4/416 • Number of events 4 • Day 1 up to 7.64 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Epilepsy
|
0.71%
3/423 • Number of events 3 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Headache
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Ischaemic stroke
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Lethargy
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.71%
3/423 • Number of events 3 • Day 1 up to 7.64 years
|
0.48%
2/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Paraesthesia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Sciatica
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Simple partial seizures
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Syncope
|
0.71%
3/423 • Number of events 3 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.72%
3/416 • Number of events 3 • Day 1 up to 7.64 years
|
|
Psychiatric disorders
Agoraphobia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Psychiatric disorders
Anxiety
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Psychiatric disorders
Depression
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.48%
2/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Psychiatric disorders
Mood disorder due to a general medical condition
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Psychiatric disorders
Neurosis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Psychiatric disorders
Panic disorder
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Psychiatric disorders
Suicide attempt
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Renal and urinary disorders
Bladder dysfunction
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Renal and urinary disorders
Haematuria
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.48%
2/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Renal and urinary disorders
Ketonuria
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.47%
2/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Reproductive system and breast disorders
Endometriosis
|
0.24%
1/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.48%
2/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Reproductive system and breast disorders
Hydrosalpinx
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.47%
2/423 • Number of events 3 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.47%
2/423 • Number of events 2 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal polyp
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Surgical and medical procedures
Cholecystectomy
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Surgical and medical procedures
Nephrectomy
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.24%
1/423 • Number of events 1 • Day 1 up to 7.64 years
|
0.00%
0/416 • Day 1 up to 7.64 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.48%
2/416 • Number of events 2 • Day 1 up to 7.64 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/423 • Day 1 up to 7.64 years
|
0.24%
1/416 • Number of events 1 • Day 1 up to 7.64 years
|
Other adverse events
| Measure |
Early Laquinimod 0.6 mg
n=423 participants at risk
All participants in MS-LAQ-301E 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-301 double-blind study who were administered laquinimod 0.6 mg daily for 24 months.
|
Switch From Placebo to Laquinimod 0.6 mg
n=416 participants at risk
All participants in MS-LAQ-301E 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-301 double-blind study who were administered placebo daily for 24 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.2%
22/423 • Number of events 25 • Day 1 up to 7.64 years
|
3.8%
16/416 • Number of events 17 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
19/423 • Number of events 23 • Day 1 up to 7.64 years
|
7.5%
31/416 • Number of events 39 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Diarrhoea
|
5.7%
24/423 • Number of events 31 • Day 1 up to 7.64 years
|
5.0%
21/416 • Number of events 23 • Day 1 up to 7.64 years
|
|
Gastrointestinal disorders
Nausea
|
5.7%
24/423 • Number of events 27 • Day 1 up to 7.64 years
|
6.2%
26/416 • Number of events 37 • Day 1 up to 7.64 years
|
|
General disorders
Fatigue
|
5.9%
25/423 • Number of events 30 • Day 1 up to 7.64 years
|
7.5%
31/416 • Number of events 38 • Day 1 up to 7.64 years
|
|
Infections and infestations
Bronchitis
|
7.8%
33/423 • Number of events 44 • Day 1 up to 7.64 years
|
7.9%
33/416 • Number of events 46 • Day 1 up to 7.64 years
|
|
Infections and infestations
Influenza
|
6.6%
28/423 • Number of events 41 • Day 1 up to 7.64 years
|
8.2%
34/416 • Number of events 46 • Day 1 up to 7.64 years
|
|
Infections and infestations
Nasopharyngitis
|
25.1%
106/423 • Number of events 169 • Day 1 up to 7.64 years
|
26.9%
112/416 • Number of events 210 • Day 1 up to 7.64 years
|
|
Infections and infestations
Sinusitis
|
6.4%
27/423 • Number of events 36 • Day 1 up to 7.64 years
|
6.7%
28/416 • Number of events 47 • Day 1 up to 7.64 years
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
43/423 • Number of events 69 • Day 1 up to 7.64 years
|
9.9%
41/416 • Number of events 65 • Day 1 up to 7.64 years
|
|
Infections and infestations
Urinary tract infection
|
13.0%
55/423 • Number of events 110 • Day 1 up to 7.64 years
|
9.4%
39/416 • Number of events 76 • Day 1 up to 7.64 years
|
|
Injury, poisoning and procedural complications
Fall
|
4.7%
20/423 • Number of events 30 • Day 1 up to 7.64 years
|
5.5%
23/416 • Number of events 30 • Day 1 up to 7.64 years
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
13/423 • Number of events 16 • Day 1 up to 7.64 years
|
5.3%
22/416 • Number of events 27 • Day 1 up to 7.64 years
|
|
Investigations
C-reactive protein increased
|
6.1%
26/423 • Number of events 31 • Day 1 up to 7.64 years
|
7.5%
31/416 • Number of events 37 • Day 1 up to 7.64 years
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.2%
22/423 • Number of events 27 • Day 1 up to 7.64 years
|
3.8%
16/416 • Number of events 23 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
41/423 • Number of events 57 • Day 1 up to 7.64 years
|
11.3%
47/416 • Number of events 59 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.4%
78/423 • Number of events 127 • Day 1 up to 7.64 years
|
18.5%
77/416 • Number of events 124 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.6%
11/423 • Number of events 15 • Day 1 up to 7.64 years
|
6.0%
25/416 • Number of events 29 • Day 1 up to 7.64 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.6%
28/423 • Number of events 35 • Day 1 up to 7.64 years
|
7.9%
33/416 • Number of events 45 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Headache
|
13.5%
57/423 • Number of events 132 • Day 1 up to 7.64 years
|
20.7%
86/416 • Number of events 160 • Day 1 up to 7.64 years
|
|
Nervous system disorders
Multiple sclerosis relapse
|
4.0%
17/423 • Number of events 35 • Day 1 up to 7.64 years
|
7.0%
29/416 • Number of events 36 • Day 1 up to 7.64 years
|
|
Psychiatric disorders
Depression
|
8.3%
35/423 • Number of events 41 • Day 1 up to 7.64 years
|
6.7%
28/416 • Number of events 35 • Day 1 up to 7.64 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
24/423 • Number of events 26 • Day 1 up to 7.64 years
|
8.4%
35/416 • Number of events 40 • Day 1 up to 7.64 years
|
|
Vascular disorders
Hypertension
|
7.6%
32/423 • Number of events 32 • Day 1 up to 7.64 years
|
6.2%
26/416 • Number of events 26 • Day 1 up to 7.64 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