Trial Outcomes & Findings for Safety and Efficacy Study of Sebelipase Alfa in Participants With Lysosomal Acid Lipase Deficiency (NCT NCT02112994)
NCT ID: NCT02112994
Last Updated: 2019-12-04
Results Overview
The number of participants experiencing severe TEAEs is presented for participants who received sebelipase alfa in this open-label study. Adverse events (AEs) information was obtained at each scheduled contact with the participant (or participant's parent or legal guardian). An AE was defined as any untoward medical occurrence that did not require a causal relationship with study drug administration. An AE could have been any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. Pre-existing conditions that worsened in severity during the study were reported as AEs. A summary of all serious and other non-serious AEs regardless of causality is located in the Reported AE module. Severity assessed using Clinical Data Interchange Standards Consortium Study Data Tabulation Model standard terminology v3.1.1. Data presented only according to age group, not dose of study drug received.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Screening, Week 144
Results posted on
2019-12-04
Participant Flow
A total of 21 study centers were initiated in 15 countries, including Australia, Belgium, Brazil, Canada, Croatia, Denmark, Germany, Italy, Mexico, Netherlands, Russia, Spain, Turkey, United Kingdom (UK), and the United States. Seventeen study centers screened at least 1 participant in all of these countries, except the UK and the Netherlands.
All participants began treatment with sebelipase alfa at a dose of 1 milligram/kilogram (mg/kg) every other week (qow). Individual participants could escalate/decrease their dose at any time during the study and only at the discretion of the Investigator and in consultation with the Sponsor. All 5 different doses are presented as Milestones below.
Participant milestones
| Measure |
2-<4 Years
This subgroup is part of the full analysis set and includes only participants between the ages of 2 and 4 years old who initiated intravenous (IV) treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg every week (qw) was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
4-18 Years
This subgroup is part of the full analysis set and includes only participants between the ages of 4 and 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
>18 Years
This subgroup is part of the full analysis set and includes only participants greater than 18 years old. This subgroup is part of the full analysis set and includes only participants greater than 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
16
|
9
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
6
|
16
|
9
|
|
Overall Study
Received 0.35 mg/kg QOW
|
0
|
0
|
1
|
|
Overall Study
Received 1 mg/kg QOW
|
6
|
16
|
9
|
|
Overall Study
Received 1 mg/kg QW
|
1
|
1
|
0
|
|
Overall Study
Received 3 mg/kg QOW
|
3
|
5
|
3
|
|
Overall Study
Received 3 mg/kg QW
|
2
|
1
|
1
|
|
Overall Study
Completed 96-week Treatment Period
|
6
|
14
|
8
|
|
Overall Study
COMPLETED
|
6
|
14
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
3
|
Reasons for withdrawal
| Measure |
2-<4 Years
This subgroup is part of the full analysis set and includes only participants between the ages of 2 and 4 years old who initiated intravenous (IV) treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg every week (qw) was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
4-18 Years
This subgroup is part of the full analysis set and includes only participants between the ages of 4 and 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
>18 Years
This subgroup is part of the full analysis set and includes only participants greater than 18 years old. This subgroup is part of the full analysis set and includes only participants greater than 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
|---|---|---|---|
|
Overall Study
Progressive Disease
|
0
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
1
|
1
|
|
Overall Study
Liver Transplant
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Sebelipase Alfa in Participants With Lysosomal Acid Lipase Deficiency
Baseline characteristics by cohort
| Measure |
Sebelipase Alfa
n=31 Participants
Pediatric and adult participants initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
|---|---|
|
Age, Continuous
|
16.82 years
STANDARD_DEVIATION 14.674 • n=39 Participants
|
|
Age, Customized
2 to <4 years
|
6 Participants
n=39 Participants
|
|
Age, Customized
4 to 18 years
|
16 Participants
n=39 Participants
|
|
Age, Customized
>18 years
|
9 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
White
|
27 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Screening, Week 144Population: Full Analysis Set: All participants who received at least 1 infusion of sebelipase alfa. The full analysis set was used for analysis of safety and efficacy.
The number of participants experiencing severe TEAEs is presented for participants who received sebelipase alfa in this open-label study. Adverse events (AEs) information was obtained at each scheduled contact with the participant (or participant's parent or legal guardian). An AE was defined as any untoward medical occurrence that did not require a causal relationship with study drug administration. An AE could have been any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. Pre-existing conditions that worsened in severity during the study were reported as AEs. A summary of all serious and other non-serious AEs regardless of causality is located in the Reported AE module. Severity assessed using Clinical Data Interchange Standards Consortium Study Data Tabulation Model standard terminology v3.1.1. Data presented only according to age group, not dose of study drug received.
Outcome measures
| Measure |
2-<4 Years
n=6 Participants
This subgroup is part of the full analysis set and includes only participants between the ages of 2 and 4 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
4-18 Years
n=16 Participants
This subgroup is part of the full analysis set and includes only participants between the ages of 4 and 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
>18 Years
n=9 Participants
This subgroup is part of the full analysis set and includes only participants greater than 18 years old. This subgroup is part of the full analysis set and includes only participants greater than 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
|---|---|---|---|
|
Participants Experiencing Severe Treatment-emergent Adverse Events (TEAEs)
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Full Analysis Set: All participants who received at least 1 infusion of sebelipase alfa. The full analysis set was used for analysis of safety and efficacy.
The effect of sebelipase alfa on lipid metabolism was evaluated by measuring the change from baseline to Week 144 in 4 serum lipids: low-density lipoprotein cholesterol (LDL-C); high-density lipoprotein cholesterol (HDL-C); non-HDL-C; triglycerides. Blood samples for these clinical laboratory tests were collected at scheduled time points and analyzed by a central laboratory.
Outcome measures
| Measure |
2-<4 Years
n=5 Participants
This subgroup is part of the full analysis set and includes only participants between the ages of 2 and 4 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
4-18 Years
n=12 Participants
This subgroup is part of the full analysis set and includes only participants between the ages of 4 and 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
>18 Years
n=2 Participants
This subgroup is part of the full analysis set and includes only participants greater than 18 years old. This subgroup is part of the full analysis set and includes only participants greater than 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
|---|---|---|---|
|
Percent Change In Serum Lipids From Baseline To Week 144
LDL-C
|
-37.5 Percent Change
Interval -52.0 to -25.0
|
-29.2 Percent Change
Interval -59.0 to 23.0
|
-22.5 Percent Change
Interval -37.0 to -8.0
|
|
Percent Change In Serum Lipids From Baseline To Week 144
HDL-C
|
76.5 Percent Change
Interval 30.0 to 132.0
|
24.2 Percent Change
Interval -4.0 to 90.0
|
6.1 Percent Change
Interval -10.0 to 22.0
|
|
Percent Change In Serum Lipids From Baseline To Week 144
Non-HDL-C
|
-39.1 Percent Change
Interval -53.0 to -29.0
|
-26.7 Percent Change
Interval -62.0 to 19.0
|
-22.1 Percent Change
Interval -33.0 to -11.0
|
|
Percent Change In Serum Lipids From Baseline To Week 144
Triglycerides
|
-48.3 Percent Change
Interval -61.0 to -11.0
|
-15.8 Percent Change
Interval -74.0 to 112.0
|
-22.0 Percent Change
Interval -25.0 to -19.0
|
SECONDARY outcome
Timeframe: Week 144Population: Full Analysis Set: All participants who received at least 1 infusion of sebelipase alfa. The full analysis set was used for analysis of safety and efficacy.
The impact of ADAs on the safety and immunogenicity of sebelipase alfa was evaluated by testing for ADAs in participants who received sebelipase alfa in this open-label study. Blood samples for assessment were collected prior to study infusions at Week 2, Week 4, Week 8, Week 12, and every 12 weeks thereafter. Participants testing positive for ADAs were also tested for the presence of neutralizing antibodies that inhibited sebelipase alfa enzyme activity and/or cellular uptake. Any participant experiencing a moderate or severe infusion-associated reaction (IAR) was to have an additional assessment of ADAs at the next study visit (prior to study drug infusion); these participants were to also have serum samples collected at 1 to 2 hours after IAR onset and at the next study visit (prior to study drug infusion) for analysis of serum tryptase. The count of participants who became ADA positive and who tested positive for neutralizing antibodies are presented.
Outcome measures
| Measure |
2-<4 Years
n=31 Participants
This subgroup is part of the full analysis set and includes only participants between the ages of 2 and 4 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
4-18 Years
This subgroup is part of the full analysis set and includes only participants between the ages of 4 and 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
>18 Years
This subgroup is part of the full analysis set and includes only participants greater than 18 years old. This subgroup is part of the full analysis set and includes only participants greater than 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
|---|---|---|---|
|
Participants Testing Positive For Anti-drug Antibodies (ADAs)
ADA Positive
|
2 Participants
|
—
|
—
|
|
Participants Testing Positive For Anti-drug Antibodies (ADAs)
Neutralizing Antibodies Positive
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Full Analysis Set: All pediatric participants who received at least 1 infusion of sebelipase alfa. The full analysis set was used for analysis of safety and efficacy.
To evaluate the effects of sebelipase alfa on growth parameters in pediatric participants (≤18 years old) presenting with evidence of growth delay, the percent change in the anthropometric parameter of BMI-for-age percentile from Baseline to Week 144 is reported. Anthropometric parameters were plotted on standard growth curves. When possible, historical data on growth parameters was also incorporated into the analyses. Percentiles and Z-scores for BMI-for-age were determined using standard growth charts appropriate to a participant's age on the date of the assessment: the World Health Organization standard growth chart for participants ≤2 years of age and the Centers for Disease Control standard growth chart for participants \>2 years of age.
Outcome measures
| Measure |
2-<4 Years
n=17 Participants
This subgroup is part of the full analysis set and includes only participants between the ages of 2 and 4 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
4-18 Years
This subgroup is part of the full analysis set and includes only participants between the ages of 4 and 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
>18 Years
This subgroup is part of the full analysis set and includes only participants greater than 18 years old. This subgroup is part of the full analysis set and includes only participants greater than 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
|---|---|---|---|
|
Percent Change In Body Mass Index (BMI)-For-Age Percentile From Baseline To Week 144 In Pediatric Participants
|
26.45 Percent Change
Standard Deviation 118.432
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 144Population: Full Analysis Set: All participants who received at least 1 infusion of sebelipase alfa. The full analysis set was used for analysis of safety and efficacy.
In order to evaluate the effects of sebelipase alfa on liver function, the number of participants with a shift in Child-Pugh status from Baseline to Week 144 is reported. The status is based on the Child-Pugh score, which is used in clinical practice to assess prognosis in individuals with chronic liver disease. Laboratory data were used in derivation of the score by summing individual scores (scored 1-3, with 3 indicating most severe) from clinical laboratory test results and physical examinations, including total serum bilirubin, serum albumin, prothrombin time, ascites, and hepatic encephalopathy. The total score was used to determine the Child-Pugh status, reported as Class A (score of 5 or 6), Class B (score of 7 to 9), or Class C (score of 10 to 15). Higher scores and higher categories represented a worse outcome. Data reported as 1 of 2 types of shifts in class: No Change from Baseline; Decline from Baseline.
Outcome measures
| Measure |
2-<4 Years
n=18 Participants
This subgroup is part of the full analysis set and includes only participants between the ages of 2 and 4 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
4-18 Years
This subgroup is part of the full analysis set and includes only participants between the ages of 4 and 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
>18 Years
This subgroup is part of the full analysis set and includes only participants greater than 18 years old. This subgroup is part of the full analysis set and includes only participants greater than 18 years old who initiated IV treatment with sebelipase alfa at a dose of 1 mg/kg qow. Participants were considered for a dose adjustment at the discretion of the Investigator and in consultation with the Sponsor. Dose escalation to 3 mg/kg qow was considered if pre-defined dose-escalation criteria were met. If these criteria continued to be met, a subsequent dose escalation to 3 mg/kg qw was considered. Dose decreases as low as 0.35 mg/kg qow were permitted based upon evidence of intolerance to sebelipase alfa treatment. Participants who completed the 96-week treatment period were permitted to continue receiving sebelipase alfa in an expanded treatment period for up to 48 weeks, pending local drug availability and study participation status.
|
|---|---|---|---|
|
Shift In Child-Pugh Status From Baseline To Week 144
No Change: A to A
|
16 Participants
|
—
|
—
|
|
Shift In Child-Pugh Status From Baseline To Week 144
No Change: B to B
|
1 Participants
|
—
|
—
|
|
Shift In Child-Pugh Status From Baseline To Week 144
Decline: A to B
|
1 Participants
|
—
|
—
|
Adverse Events
0.35 mg/kg QOW
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1.0 mg/kg QOW
Serious events: 8 serious events
Other events: 30 other events
Deaths: 0 deaths
1.0 mg/kg QW
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3.0 mg/kg QOW
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
3.0 mg/kg QW
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
0.35 mg/kg QOW
n=1 participants at risk
This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 0.35 mg/kg qow.
|
1.0 mg/kg QOW
n=31 participants at risk
This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 1.0 mg/kg qow.
|
1.0 mg/kg QW
n=2 participants at risk
This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 1.0 mg/kg qw.
|
3.0 mg/kg QOW
n=11 participants at risk
This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 3.0 mg/kg qow.
|
3.0 mg/kg QW
n=4 participants at risk
This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 3.0 mg/kg qw.
|
|---|---|---|---|---|---|
|
Product Issues
Device breakage
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Surgical and medical procedures
Liver transplant
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Vascular disorders
Shock
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.7%
3/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
Other adverse events
| Measure |
0.35 mg/kg QOW
n=1 participants at risk
This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 0.35 mg/kg qow.
|
1.0 mg/kg QOW
n=31 participants at risk
This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 1.0 mg/kg qow.
|
1.0 mg/kg QW
n=2 participants at risk
This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 1.0 mg/kg qw.
|
3.0 mg/kg QOW
n=11 participants at risk
This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 3.0 mg/kg qow.
|
3.0 mg/kg QW
n=4 participants at risk
This reporting group is based on the safety set and includes AEs with onset during the administration of IV treatment of sebelipase alfa at a dose of 3.0 mg/kg qw.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Blood and lymphatic system disorders
Macrocytosis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Cardiac disorders
Left ventricular dilatation
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Endocrine disorders
Delayed puberty
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
35.5%
11/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
18.2%
2/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
16.1%
5/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
18.2%
2/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.7%
3/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
38.7%
12/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
18.2%
2/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
18.2%
2/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.7%
3/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
18.2%
2/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Oral contusion
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Tongue eruption
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
29.0%
9/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
18.2%
2/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
48.4%
15/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
36.4%
4/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
General disorders
Vaccination site erythema
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.7%
3/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Ear infection
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.7%
3/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Eye infection
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
19.4%
6/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
50.0%
2/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.7%
3/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Molluscum contagiosum
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
41.9%
13/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
36.4%
4/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
75.0%
3/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
18.2%
2/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.7%
3/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
19.4%
6/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
22.6%
7/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.7%
3/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.7%
3/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
22.6%
7/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
18.2%
2/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
50.0%
2/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Viral infection
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
12.9%
4/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
27.3%
3/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Investigations
Body temperature increased
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.7%
3/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Investigations
Protein total decreased
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
12.9%
4/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
18.2%
2/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.7%
3/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
32.3%
10/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Nervous system disorders
Migraine
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
33.3%
1/3 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
22.6%
7/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
16.1%
5/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
27.3%
3/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.7%
3/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.7%
3/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
12.9%
4/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
18.2%
2/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
6.5%
2/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Vascular disorders
Haematoma
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
18.2%
2/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
3.2%
1/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
25.0%
1/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/1 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/31 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/2 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
9.1%
1/11 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
0.00%
0/4 • Screening (up to 45 days prior to start of treatment) to Week 144.
All serious and non-serious AE data are displayed by the study drug administered at the time of AE onset.
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Phone: 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place