Trial Outcomes & Findings for Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists) (NCT NCT02106156)
NCT ID: NCT02106156
Last Updated: 2016-09-23
Results Overview
RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.
Recruitment status
COMPLETED
Target enrollment
10228 participants
Primary outcome timeframe
At Week 4
Results posted on
2016-09-23
Participant Flow
Per protocol participants were not allocated to study arms. Separation of participants was performed post hoc for all analyses. Participants who underwent elastography were allocated to separate arms as another time schedule was used and also untreated participants were documented, who were analyzed separately from treated participants.
Participant milestones
| Measure |
Main Analysis Set
Participants with chronic hepatitis C (CHC) treated with pegylated interferon (peginterferon) alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding summary of product characteristics (SmPC).
|
Elastography Analysis Set: Treated
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with hepatitis C virus (HCV) treatment as indicated.
|
Elastography Analysis Set: Untreated
The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9620
|
90
|
518
|
|
Overall Study
COMPLETED
|
7071
|
50
|
518
|
|
Overall Study
NOT COMPLETED
|
2549
|
40
|
0
|
Reasons for withdrawal
| Measure |
Main Analysis Set
Participants with chronic hepatitis C (CHC) treated with pegylated interferon (peginterferon) alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding summary of product characteristics (SmPC).
|
Elastography Analysis Set: Treated
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with hepatitis C virus (HCV) treatment as indicated.
|
Elastography Analysis Set: Untreated
The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
|
|---|---|---|---|
|
Overall Study
Patient Died
|
19
|
0
|
0
|
|
Overall Study
Lack of Tolerability
|
305
|
3
|
0
|
|
Overall Study
Lack of Virological Response
|
1044
|
8
|
0
|
|
Overall Study
Concomitant Disease
|
74
|
2
|
0
|
|
Overall Study
Lack of Compliance
|
211
|
7
|
0
|
|
Overall Study
Patients Request
|
307
|
9
|
0
|
|
Overall Study
Lost to Follow-up
|
451
|
8
|
0
|
|
Overall Study
Unplanned Event
|
82
|
2
|
0
|
|
Overall Study
Change of Laboratory Parameter
|
10
|
0
|
0
|
|
Overall Study
Hospitalization/Surgical Intervention
|
6
|
0
|
0
|
|
Overall Study
Relocation/Change of Physician
|
40
|
1
|
0
|
Baseline Characteristics
Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)
Baseline characteristics by cohort
| Measure |
Main Analysis Set
n=9620 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
|
Elastography Analysis Set: Treated
n=90 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
|
Elastography Analysis Set: Untreated
n=518 Participants
The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
|
Total
n=10228 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
44.9 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3273 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
3513 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6347 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
6715 Participants
n=4 Participants
|
|
Number of Participants With Each Hepatitis C Viral Genotype
Genotype 1
|
5699 participants
n=5 Participants
|
51 participants
n=7 Participants
|
377 participants
n=5 Participants
|
6127 participants
n=4 Participants
|
|
Number of Participants With Each Hepatitis C Viral Genotype
Genotype 2
|
544 participants
n=5 Participants
|
3 participants
n=7 Participants
|
11 participants
n=5 Participants
|
558 participants
n=4 Participants
|
|
Number of Participants With Each Hepatitis C Viral Genotype
Genotype 3
|
2903 participants
n=5 Participants
|
30 participants
n=7 Participants
|
89 participants
n=5 Participants
|
3022 participants
n=4 Participants
|
|
Number of Participants With Each Hepatitis C Viral Genotype
Genotype 4
|
421 participants
n=5 Participants
|
6 participants
n=7 Participants
|
18 participants
n=5 Participants
|
445 participants
n=4 Participants
|
|
Number of Participants With Each Hepatitis C Viral Genotype
Genotype 5
|
17 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
19 participants
n=4 Participants
|
|
Number of Participants With Each Hepatitis C Viral Genotype
Genotype 6
|
15 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Number of Participants With Each Hepatitis C Viral Genotype
Genotype unknown
|
21 participants
n=5 Participants
|
0 participants
n=7 Participants
|
20 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Number of Participants With Low or High Viral Load
Low viral load
|
3769 participants
n=5 Participants
|
24 participants
n=7 Participants
|
139 participants
n=5 Participants
|
3932 participants
n=4 Participants
|
|
Number of Participants With Low or High Viral Load
High viral load
|
5771 participants
n=5 Participants
|
66 participants
n=7 Participants
|
356 participants
n=5 Participants
|
6193 participants
n=4 Participants
|
|
Number of Participants With Low or High Viral Load
Not determined/not assessable
|
80 participants
n=5 Participants
|
0 participants
n=7 Participants
|
23 participants
n=5 Participants
|
103 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Week 4Population: Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 4.
RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.
Outcome measures
| Measure |
Main Analysis Set
n=6442 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
|
Elastography Analysis Set: Treated
n=60 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
|
|---|---|---|
|
Percentage of Participants With Rapid Virologic Response (RVR)
|
40.0 percentage of participants
|
41.7 percentage of participants
|
PRIMARY outcome
Timeframe: At Week 12Population: Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 12.
EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.
Outcome measures
| Measure |
Main Analysis Set
n=7383 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
|
Elastography Analysis Set: Treated
n=54 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
|
|---|---|---|
|
Percentage of Participants With Early Virologic Response (EVR)
|
71.2 percentage of participants
|
77.8 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 72Population: Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.
EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.
Outcome measures
| Measure |
Main Analysis Set
n=9620 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
|
Elastography Analysis Set: Treated
n=90 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
|
|---|---|---|
|
Percentage of Participants With End of Treatment (EOT) Response
|
59.2 percentage of participants
|
51.1 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 96Population: Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.
SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.
Outcome measures
| Measure |
Main Analysis Set
n=9620 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
|
Elastography Analysis Set: Treated
n=90 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
|
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR)
|
41.4 percentage of participants
|
36.7 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 96Population: Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.
Outcome measures
| Measure |
Main Analysis Set
n=9620 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
|
Elastography Analysis Set: Treated
n=90 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Drug Reactions (SADR)
|
3.5 percentage of participants
|
3.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 96Population: Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.
Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.
Outcome measures
| Measure |
Main Analysis Set
n=9005 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
|
Elastography Analysis Set: Treated
n=90 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
|
|---|---|---|
|
Percentage Cumulative Dose of Peginterferon Alfa-2a Received
|
97.9 percentage of cumulated dose
Interval 1.04 to 400.0
|
94.8 percentage of cumulated dose
Interval 4.17 to 350.0
|
SECONDARY outcome
Timeframe: Up to Week 96Population: Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.
Data for the accumulation of the cumulative dose of ribavirin were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.
Outcome measures
| Measure |
Main Analysis Set
n=8971 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
|
Elastography Analysis Set: Treated
n=89 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
|
|---|---|---|
|
Percentage Cumulative Dose of Ribavirin Received
|
100.00 percentage of cumulated dose
Interval 0.0 to 500.0
|
97.92 percentage of cumulated dose
Interval 8.33 to 480.21
|
SECONDARY outcome
Timeframe: Up to Week 72Population: Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.
Treatment duration was evaluated for participants for whom dates of treatment start and end of therapy were documented.
Outcome measures
| Measure |
Main Analysis Set
n=8993 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
|
Elastography Analysis Set: Treated
n=90 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
|
|---|---|---|
|
Duration of Peginterferon Alfa-2a Therapy
|
27.3 weeks
Interval 1.0 to 106.1
|
29.3 weeks
Interval 1.1 to 84.1
|
SECONDARY outcome
Timeframe: At Baseline (Day 1)Population: Only main analysis set had evaluable data for this outcome measure.
Most frequent concomitant medications were defined as those, which were observed in \>1 % of participants.
Outcome measures
| Measure |
Main Analysis Set
n=9620 Participants
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
|
Elastography Analysis Set: Treated
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
|
|---|---|---|
|
Percentage of Participants With the Most Frequent Concomitant Medications
Anilides
|
10.6 percentage of participants
|
—
|
|
Percentage of Participants With the Most Frequent Concomitant Medications
Selective serotonin reuptake inhibitors
|
9.9 percentage of participants
|
—
|
|
Percentage of Participants With the Most Frequent Concomitant Medications
Proton pump inhibitors
|
5.3 percentage of participants
|
—
|
|
Percentage of Participants With the Most Frequent Concomitant Medications
Propionic acid derivatives
|
4.7 percentage of participants
|
—
|
|
Percentage of Participants With the Most Frequent Concomitant Medications
Propulsives
|
2.3 percentage of participants
|
—
|
|
Percentage of Participants With the Most Frequent Concomitant Medications
Other antidepressants
|
2.3 percentage of participants
|
—
|
|
Percentage of Participants With the Most Frequent Concomitant Medications
Angiotensin-converting-enzyme (ACE) inhibitors
|
2.0 percentage of participants
|
—
|
|
Percentage of Participants With the Most Frequent Concomitant Medications
Thyroid hormones
|
1.8 percentage of participants
|
—
|
|
Percentage of Participants With the Most Frequent Concomitant Medications
Corticosteroids, potent (group III)
|
1.7 percentage of participants
|
—
|
|
Percentage of Participants With the Most Frequent Concomitant Medications
Benzodiazepine related drugs
|
1.5 percentage of participants
|
—
|
|
Percentage of Participants With the Most Frequent Concomitant Medications
Pyrazolones
|
1.4 percentage of participants
|
—
|
|
Percentage of Participants With the Most Frequent Concomitant Medications
Beta blocking agents, selective
|
1.3 percentage of participants
|
—
|
|
Percentage of Participants With the Most Frequent Concomitant Medications
Non-selective monoamine reuptake inhibitors
|
1.2 percentage of participants
|
—
|
Adverse Events
Main Analysis Set
Serious events: 439 serious events
Other events: 5721 other events
Deaths: 0 deaths
Elastography Analysis Set: Treated
Serious events: 4 serious events
Other events: 82 other events
Deaths: 0 deaths
Elastography Analysis Set: Untreated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Main Analysis Set
n=9620 participants at risk
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
|
Elastography Analysis Set: Treated
n=90 participants at risk
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those, who were treated with HCV treatment as indicated.
|
Elastography Analysis Set: Untreated
n=518 participants at risk
Participants with CHC in the untreated elastography analysis set includes those participants, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.36%
35/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Blood and lymphatic system disorders
Autoimmune thrombocytopenia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Blood and lymphatic system disorders
Haematotoxicity
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.06%
6/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.15%
14/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.08%
8/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
1.1%
1/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.18%
17/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Angina pectoris
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Arrhythmia
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Arteriospasm coronary
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Atrial fibrillation
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Cardiac failure
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Cardiac perforation
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Cardiomyopathy
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Hemianopia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Coronary artery disease
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Myocardial infarction
|
0.05%
5/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Palpitations
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Pericarditis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Cardiac disorders
Tachycardia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Congenital, familial and genetic disorders
Factor VIII deficiency
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Congenital, familial and genetic disorders
Intestinal atresia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Ear and labyrinth disorders
Ossicle disorder
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Endocrine disorders
Basedow's disease
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Endocrine disorders
Hyperthyroidism
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Endocrine disorders
Hypothyroidism
|
0.04%
4/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Eye disorders
Eyelid oedema
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Eye disorders
Retinal disorder
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.05%
5/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Anal fistula
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Ascites
|
0.06%
6/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Haematemesis
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Haematochezia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Ileus
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Melaena
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Nausea
|
0.06%
6/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.04%
4/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Periodontitis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Teeth brittle
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Tooth loss
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Vomiting
|
0.04%
4/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Asthenia
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Chest pain
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Chills
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Death
|
0.04%
4/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Disease progression
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Drug ineffective
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Fatigue
|
0.05%
5/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
General physical health deterioration
|
0.05%
5/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Generalised oedema
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Granuloma
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Influenza like illness
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
No therapeutic response
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Pyrexia
|
0.08%
8/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Serositis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Sudden cardiac death
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Hepatobiliary disorders
Cholangitis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Hepatobiliary disorders
Hepatic artery occlusion
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Hepatobiliary disorders
Hepatic failure
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.04%
4/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Hepatobiliary disorders
Jaundice
|
0.05%
5/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Immune system disorders
Decreased immune responsiveness
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Immune system disorders
Sarcoidosis
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Abscess
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Abscess jaw
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Anal abscess
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Appendicitis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Bronchopneumonia
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Cellulitis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Device related infection
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Diverticulitis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Empyema
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Endocarditis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Enterocolitis infectious
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Febrile infection
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Furuncle
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Gastroenteritis
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Gastrointestinal infection
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Groin abscess
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Hepatitis C
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Herpes zoster
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
HIV infection
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Infection
|
0.06%
6/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Infectious pleural effusion
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Injection site abscess
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Intervertebral discitis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Laryngitis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Latent tuberculosis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Malaria
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Nasal vestibulitis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Otitis media
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Pilonidal cyst
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Pneumonia
|
0.28%
27/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
1.1%
1/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Pneumonia bacterial
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Pneumonia fungal
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Pyelonephritis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Sepsis
|
0.06%
6/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Septic shock
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Tuberculosis
|
0.05%
5/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Urinary tract infection
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Urosepsis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Accident
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Accident at home
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Fall
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Injury
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.06%
6/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.04%
4/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Hyperaesthesia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Alanine aminotransferase increased
|
0.05%
5/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Aspartate aminotransferase increased
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Bilirubin conjugated increased
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Biopsy liver
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Blood bilirubin increased
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Blood cholinesterase decreased
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Blood count abnormal
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Blood creatinine increased
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Blood glucose fluctuation
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Blood glucose increased
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Blood urea increased
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Electrocardiogram change
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.04%
4/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Haemoglobin decreased
|
0.18%
17/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Heart rate increased
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Hepatitis C RNA increased
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Lymphocyte count decreased
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Platelet count decreased
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Prothrombin time prolonged
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Renal function test abnormal
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Transaminases increased
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Viral load increased
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Waist circumference increased
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Weight decreased
|
0.04%
4/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
White blood cell count decreased
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Metabolism and nutrition disorders
Cachexia
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Vascular disorders
Hypertension
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Musculoskeletal and connective tissue disorders
Bursa disorder
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Musculoskeletal and connective tissue disorders
Muscle oedema
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Germ cell cancer
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.04%
4/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant recurrent
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant resectable
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Vascular disorders
Hypertensive crisis
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seminoma
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Altered state of consciousness
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Aphasia
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Brain stem infarction
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Carotid artery occlusion
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Cerebral ischaemia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.04%
4/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Coma
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Convulsion
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Dementia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Dizziness
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Dysarthria
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Encephalopathy
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Facial paresis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Headache
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Hypoaesthesia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Intercostal neuralgia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Loss of consciousness
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Multiple sclerosis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Nervous system disorder
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Paraesthesia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Polyneuropathy
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Syncope
|
0.04%
4/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Acute psychosis
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Aggression
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Alcohol abuse
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Alcohol problem
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Alcoholism
|
0.10%
10/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Anger
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Anxiety
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Completed suicide
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Confusional state
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Delirium
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Dependence
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Depressed mood
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Depression
|
0.21%
20/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Drug dependence
|
0.08%
8/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Psychotic disorder
|
0.18%
17/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
1.1%
1/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Schizophrenia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Sleep disorder
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Suicidal ideation
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Suicide attempt
|
0.05%
5/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Renal and urinary disorders
Calculus ureteric
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Renal and urinary disorders
Renal failure
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Renal and urinary disorders
Renal failure acute
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Renal and urinary disorders
Urinary retention
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Reproductive system and breast disorders
Breast induration
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Reproductive system and breast disorders
Breast pain
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Reproductive system and breast disorders
Endometriosis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Reproductive system and breast disorders
Scrotal ulcer
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.05%
5/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.05%
5/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.05%
5/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Skin and subcutaneous tissue disorders
Skin discomfort
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.05%
5/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Social circumstances
Drug abuse
|
0.03%
3/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Social circumstances
Drug abuser
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Social circumstances
Substance use
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Surgical and medical procedures
Abortion induced
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Surgical and medical procedures
Detoxification
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Surgical and medical procedures
Hospitalisation
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Surgical and medical procedures
Liver transplant
|
0.00%
0/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
1.1%
1/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Surgical and medical procedures
Oophorectomy
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Vascular disorders
Angiodysplasia
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Vascular disorders
Circulatory collapse
|
0.02%
2/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Vascular disorders
Deep vein thrombosis
|
0.04%
4/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Vascular disorders
Femoral artery embolism
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Vascular disorders
Haemorrhage
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Vascular disorders
Thrombosis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Vascular disorders
Venous thrombosis
|
0.01%
1/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
Other adverse events
| Measure |
Main Analysis Set
n=9620 participants at risk
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
|
Elastography Analysis Set: Treated
n=90 participants at risk
Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those, who were treated with HCV treatment as indicated.
|
Elastography Analysis Set: Untreated
n=518 participants at risk
Participants with CHC in the untreated elastography analysis set includes those participants, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.9%
471/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
41.1%
37/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.2%
311/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
33.3%
30/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
299/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
34.4%
31/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
187/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
7.8%
7/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Cheilitis
|
0.10%
10/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
6.7%
6/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Gastritis
|
0.29%
28/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
6.7%
6/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
1.3%
121/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
5.6%
5/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Nausea
|
8.5%
820/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
17.8%
16/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Gastrointestinal disorders
Vomiting
|
0.74%
71/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
5.6%
5/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Fatigue
|
35.1%
3380/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
54.4%
49/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Influenza like illness
|
4.5%
433/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
6.7%
6/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Irritability
|
6.6%
637/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
General disorders
Pyrexia
|
8.3%
801/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
6.7%
6/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Infections and infestations
Oral candidiasis
|
0.56%
54/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
6.7%
6/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Investigations
Weight decreased
|
9.3%
890/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
24.4%
22/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.1%
1258/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
7.8%
7/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
873/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
10.0%
9/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Dizziness
|
2.4%
232/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
6.7%
6/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Headache
|
14.0%
1348/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
16.7%
15/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Nervous system disorders
Visual field defect
|
0.04%
4/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
5.6%
5/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Depressed mood
|
9.0%
865/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
17.8%
16/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Depression
|
7.3%
705/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
20.0%
18/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Insomnia
|
8.9%
857/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
10.0%
9/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Psychiatric disorders
Sleep disorder
|
2.4%
234/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
7.8%
7/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
247/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
13.3%
12/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.8%
555/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
6.7%
6/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.64%
62/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
7.8%
7/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
569/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
11.1%
10/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
13.7%
1316/9620 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
21.1%
19/90 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
0.00%
0/518 • Up to Week 96
The assessment type for the Main analysis set and Elastography analysis set: treated was systematic (reported by the participants in response to questioning in the course of each study visit) whereas the assessment type for the Elastography analysis set: untreated was non-systematic (spontaneously reported by the participant).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER