Trial Outcomes & Findings for An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema (NCT NCT04307381)
NCT ID: NCT04307381
Last Updated: 2026-05-08
Results Overview
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the AE is considered related to the medicinal (investigational) product. TEAEs were defined as those AEs that either started or worsened in severity on or after the date/time of first administration of study drug in this OLE Study. TEAEs included both serious and non-serious TEAEs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Up to Week 221
Results posted on
2026-05-08
Participant Flow
Participants took part in the study from 31 March 2020 to 24 January 2025.
A total of 20 subjects were enrolled to receive study drug ISIS 721744 in this study.
Participant milestones
| Measure |
HAE-1/HAE-2
Participants with hereditary angioedema Type I/Type II (HAE-1/HAE-2) who received placebo or donidalorsen, 80 milligrams (mg), SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 (Fixed Dosing Period). Starting From Week 17 (Flexible Dosing Period), participants had 3 different dosing options as: 80 mg every 4 weeks, 80 mg every 8 weeks for participants who were attack-free for ≥12 weeks, 100 mg every 4 weeks for participants who were not attack-free for ≥12 weeks up to Week 53 based on the investigator and sponsor medical monitor recommendation. Participants continued flexible dosing from Week 53 for up to approximately 209 weeks.
|
HAE-nC1-INH
Participants with hereditary angioedema with normal C1-inhibitor (HAE-nC1-INH) who received donidalorsen, 80 mg, SC, once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), continued to receive donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 (Fixed Dosing Period). Starting From Week 17 (Flexible Dosing Period), participants had 2 different dosing options as: 80 mg every 4 weeks, and 100 mg every 4 weeks for participants who were not attack-free for ≥12 weeks up to Week 53 based on the investigator and sponsor medical monitor recommendation. Participants continued flexible dosing from Week 53 for up to approximately 209 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
3
|
|
Overall Study
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 4 Weeks)
|
13
|
0
|
|
Overall Study
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 8 Weeks)
|
8
|
0
|
|
Overall Study
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 100 mg Every 4 Weeks)
|
1
|
0
|
|
Overall Study
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 80 mg Every 4 Weeks)
|
0
|
1
|
|
Overall Study
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 100 mg Every 4 Weeks)
|
0
|
2
|
|
Overall Study
COMPLETED
|
16
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
HAE-1/HAE-2
Participants with hereditary angioedema Type I/Type II (HAE-1/HAE-2) who received placebo or donidalorsen, 80 milligrams (mg), SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 (Fixed Dosing Period). Starting From Week 17 (Flexible Dosing Period), participants had 3 different dosing options as: 80 mg every 4 weeks, 80 mg every 8 weeks for participants who were attack-free for ≥12 weeks, 100 mg every 4 weeks for participants who were not attack-free for ≥12 weeks up to Week 53 based on the investigator and sponsor medical monitor recommendation. Participants continued flexible dosing from Week 53 for up to approximately 209 weeks.
|
HAE-nC1-INH
Participants with hereditary angioedema with normal C1-inhibitor (HAE-nC1-INH) who received donidalorsen, 80 mg, SC, once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), continued to receive donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 (Fixed Dosing Period). Starting From Week 17 (Flexible Dosing Period), participants had 2 different dosing options as: 80 mg every 4 weeks, and 100 mg every 4 weeks for participants who were not attack-free for ≥12 weeks up to Week 53 based on the investigator and sponsor medical monitor recommendation. Participants continued flexible dosing from Week 53 for up to approximately 209 weeks.
|
|---|---|---|
|
Overall Study
Voluntary Withdrawal
|
1
|
1
|
Baseline Characteristics
An Extension Study of Donidalorsen (IONIS-PKK-LRx) in Participants With Hereditary Angioedema
Baseline characteristics by cohort
| Measure |
HAE-1/HAE-2
n=17 Participants
Participants with HAE-1/HAE-2 who received placebo or donidalorsen, 80 mg, SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 (Fixed Dosing Period). Starting From Week 17 (Flexible Dosing Period), participants had 3 different dosing options as: 80 mg every 4 weeks, 80 mg every 8 weeks for participants who were attack-free for ≥12 weeks, 100 mg every 4 weeks for participants who were not attack-free for ≥12 weeks up to Week 53 based on the investigator and sponsor medical monitor recommendation. Participants continued flexible dosing from Week 53 for up to approximately 209 weeks.
|
HAE-nC1-INH
n=3 Participants
Participants with HAE-nC1-INH who received donidalorsen, 80 mg, SC, once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), continued to receive donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 (Fixed Dosing Period). Starting From Week 17 (Flexible Dosing Period), participants had 2 different dosing options as: 80 mg every 4 weeks, and 100 mg every 4 weeks for participants who were not attack-free for ≥12 weeks up to Week 53 based on the investigator and sponsor medical monitor recommendation. Participants continued flexible dosing from Week 53 for up to approximately 209 weeks.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.9 years
STANDARD_DEVIATION 14.68 • n=41 Participants
|
34.3 years
STANDARD_DEVIATION 8.33 • n=40 Participants
|
38.3 years
STANDARD_DEVIATION 13.84 • n=81 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=41 Participants
|
3 Participants
n=40 Participants
|
14 Participants
n=81 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
6 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=41 Participants
|
3 Participants
n=40 Participants
|
19 Participants
n=81 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=81 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=41 Participants
|
3 Participants
n=40 Participants
|
19 Participants
n=81 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=81 Participants
|
PRIMARY outcome
Timeframe: Up to Week 221Population: The safety population included all enrolled participants who received at least 1 dose in the OLE study.
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the AE is considered related to the medicinal (investigational) product. TEAEs were defined as those AEs that either started or worsened in severity on or after the date/time of first administration of study drug in this OLE Study. TEAEs included both serious and non-serious TEAEs.
Outcome measures
| Measure |
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 100 mg Every 4 Weeks)
n=2 Participants
Participants with HAE-nC1-INH who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen, 100 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
Fixed-dose Period: HAE-1/HAE-2
n=17 Participants
Participants with HAE-1/HAE-2 who received placebo or donidalorsen, 80 mg, SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Fixed-dose Period: HAE-nC1-INH
n=3 Participants
Participants with HAE-nC1-INH who received placebo in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 4 Weeks)
n=13 Participants
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 8 Weeks)
n=8 Participants
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 8 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 100 mg Every 4 Weeks)
n=1 Participants
Participants with HAE-1/HAE-2 who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen 100 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 80 mg Every 4 Weeks)
n=1 Participants
Participants with HAE-nC1-INH who were attack free for ≥12 weeks after entering the OLE study received donidalorsen, 80 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
|
100 percentage of participants
|
70.6 percentage of participants
|
66.7 percentage of participants
|
84.6 percentage of participants
|
62.5 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 221Population: The safety population included all enrolled participants who received at least 1 dose in the OLE study.
Clinical laboratory tests including clinical chemistry, hematology, coagulation, complement, inflammatory, urinalysis were performed. The percentage of participants with clinically meaningful changes were reported. Clinical meaningfulness was determined by the investigator.
Outcome measures
| Measure |
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 100 mg Every 4 Weeks)
n=2 Participants
Participants with HAE-nC1-INH who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen, 100 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
Fixed-dose Period: HAE-1/HAE-2
n=17 Participants
Participants with HAE-1/HAE-2 who received placebo or donidalorsen, 80 mg, SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Fixed-dose Period: HAE-nC1-INH
n=3 Participants
Participants with HAE-nC1-INH who received placebo in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 4 Weeks)
n=13 Participants
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 8 Weeks)
n=8 Participants
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 8 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 100 mg Every 4 Weeks)
n=1 Participants
Participants with HAE-1/HAE-2 who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen 100 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 80 mg Every 4 Weeks)
n=1 Participants
Participants with HAE-nC1-INH who were attack free for ≥12 weeks after entering the OLE study received donidalorsen, 80 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinically Meaningful Changes in Clinical Laboratory Assessments
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 221Population: The safety population included all enrolled participants who received at least 1 dose in the OLE study.
Vital sign measurements including heart rate, respiratory rate, body temperature, systolic and diastolic blood pressure and pulse pressure were assessed. Percentage of participants with clinically meaningful changes in the vital signs were reported. Clinically meaningfulness was determined by the investigator.
Outcome measures
| Measure |
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 100 mg Every 4 Weeks)
n=2 Participants
Participants with HAE-nC1-INH who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen, 100 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
Fixed-dose Period: HAE-1/HAE-2
n=17 Participants
Participants with HAE-1/HAE-2 who received placebo or donidalorsen, 80 mg, SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Fixed-dose Period: HAE-nC1-INH
n=3 Participants
Participants with HAE-nC1-INH who received placebo in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 4 Weeks)
n=13 Participants
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 8 Weeks)
n=8 Participants
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 8 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 100 mg Every 4 Weeks)
n=1 Participants
Participants with HAE-1/HAE-2 who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen 100 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 80 mg Every 4 Weeks)
n=1 Participants
Participants with HAE-nC1-INH who were attack free for ≥12 weeks after entering the OLE study received donidalorsen, 80 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinically Meaningful Changes in Vital Signs
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 221Population: The safety population included all enrolled participants who received at least 1 dose in the OLE study.
The ECG parameters included ventricular rate, PR interval, QRS duration, QTc, QT corrected using the Fridericia's formula (QTcF), QT corrected using the Bazett's formula (QTcB), and overall interpretation. Percentage of participants with clinically meaningful changes in the ECG parameters were reported. Clinical meaningfulness was determined by the investigator.
Outcome measures
| Measure |
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 100 mg Every 4 Weeks)
n=2 Participants
Participants with HAE-nC1-INH who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen, 100 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
Fixed-dose Period: HAE-1/HAE-2
n=17 Participants
Participants with HAE-1/HAE-2 who received placebo or donidalorsen, 80 mg, SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Fixed-dose Period: HAE-nC1-INH
n=3 Participants
Participants with HAE-nC1-INH who received placebo in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 4 Weeks)
n=13 Participants
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 8 Weeks)
n=8 Participants
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 8 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 100 mg Every 4 Weeks)
n=1 Participants
Participants with HAE-1/HAE-2 who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen 100 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 80 mg Every 4 Weeks)
n=1 Participants
Participants with HAE-nC1-INH who were attack free for ≥12 weeks after entering the OLE study received donidalorsen, 80 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Clinically Meaningful Changes in Electrocardiograms (ECGs) Parameters
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Week 221Population: The safety population included all enrolled participants who received at least 1 dose in the OLE study. As pre-specified in SAP, this outcome measure was planned to be reported by overall for HAE-1/ HAE-2 and HAE-nC1-INH groups.
Concomitant medications include medications that participants were exposed to on or after the first dose of ISIS 721744 in the OLE study. Percentage of participants who received at least one concomitant medication were reported.
Outcome measures
| Measure |
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 100 mg Every 4 Weeks)
Participants with HAE-nC1-INH who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen, 100 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
Fixed-dose Period: HAE-1/HAE-2
n=17 Participants
Participants with HAE-1/HAE-2 who received placebo or donidalorsen, 80 mg, SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Fixed-dose Period: HAE-nC1-INH
n=3 Participants
Participants with HAE-nC1-INH who received placebo in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 4 Weeks)
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 8 Weeks)
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 8 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 100 mg Every 4 Weeks)
Participants with HAE-1/HAE-2 who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen 100 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 80 mg Every 4 Weeks)
Participants with HAE-nC1-INH who were attack free for ≥12 weeks after entering the OLE study received donidalorsen, 80 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Received At Least One Concomitant Medication
|
—
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 221Population: The intent-to-treat (ITT) population included all enrolled participants in the OLE study.
HAE attack rate was calculated for each participant as the number of HAE attacks occurring during the respective period divided by the number of days the participant contributed to this period multiplied by 28 days. An HAE attack was defined as an event with signs or symptoms consistent with an attack in at least 1 of the locations: peripheral angioedema (cutaneous swelling involving an extremity, the face, neck, torso, and/or genitourinary region), abdominal angioedema (abdominal pain, with or without abdominal distention, nausea, vomiting, or diarrhea), laryngeal angioedema (stridor, dyspnea, difficulty speaking, difficulty swallowing, throat tightening, or swelling of the tongue, palate, uvula, or larynx). A negative change from baseline in HAE attacks indicates an improvement in HAE attacks.
Outcome measures
| Measure |
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 100 mg Every 4 Weeks)
n=2 Participants
Participants with HAE-nC1-INH who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen, 100 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
Fixed-dose Period: HAE-1/HAE-2
n=17 Participants
Participants with HAE-1/HAE-2 who received placebo or donidalorsen, 80 mg, SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Fixed-dose Period: HAE-nC1-INH
n=3 Participants
Participants with HAE-nC1-INH who received placebo in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 4 Weeks)
n=13 Participants
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 8 Weeks)
n=8 Participants
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 8 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 100 mg Every 4 Weeks)
n=1 Participants
Participants with HAE-1/HAE-2 who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen 100 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 80 mg Every 4 Weeks)
n=1 Participants
Participants with HAE-nC1-INH who were attack free for ≥12 weeks after entering the OLE study received donidalorsen, 80 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Time-normalized HAE Attack (Per 4 Weeks) Rate
|
-64.04 percent change
Standard Deviation 30.597
|
-94.41 percent change
Standard Deviation 10.260
|
-60.82 percent change
Standard Deviation 19.310
|
-97.21 percent change
Standard Deviation 5.672
|
-82.70 percent change
Standard Deviation 35.598
|
-95.16 percent change
Standard Deviation NA
The SD was not estimable as there was only 1 participant in this arm.
|
-87.21 percent change
Standard Deviation NA
The SD was not estimable as there was only 1 participant in this arm.
|
SECONDARY outcome
Timeframe: Up to Week 221Population: The ITT population included all enrolled participants in the OLE study. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis for this outcome measure at specified timepoint.
The most commonly used on-demand medications during the On-Treatment Period were C1 esterase inhibitors (human) and icatibant, which were allowed per-protocol for treatment of acute attacks.
Outcome measures
| Measure |
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 100 mg Every 4 Weeks)
n=2 Participants
Participants with HAE-nC1-INH who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen, 100 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
Fixed-dose Period: HAE-1/HAE-2
n=17 Participants
Participants with HAE-1/HAE-2 who received placebo or donidalorsen, 80 mg, SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Fixed-dose Period: HAE-nC1-INH
n=3 Participants
Participants with HAE-nC1-INH who received placebo in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 4 Weeks)
n=13 Participants
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 8 Weeks)
n=8 Participants
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 8 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 100 mg Every 4 Weeks)
n=1 Participants
Participants with HAE-1/HAE-2 who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen 100 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 80 mg Every 4 Weeks)
n=1 Participants
Participants with HAE-nC1-INH who were attack free for ≥12 weeks after entering the OLE study received donidalorsen, 80 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Used On-demand Medications
By the End of Flexible Dosing Period (Week 209)
|
100 percentage of participants
|
—
|
—
|
38.5 percentage of participants
|
62.5 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Used On-demand Medications
By the End of Fixed Dosing Period (Week 17)
|
—
|
11.8 percentage of participants
|
66.7 percentage of participants
|
—
|
—
|
—
|
—
|
Adverse Events
Fixed-dose Period: HAE-1/HAE-2
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Fixed-dose Period: HAE-nC1-INH
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 4 Weeks)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 8 Weeks)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 100 mg Every 4 Weeks)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 80 mg Every 4 Weeks)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 100 mg Every 4 Weeks)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fixed-dose Period: HAE-1/HAE-2
n=17 participants at risk
Participants with HAE-1/HAE-2 who received placebo or donidalorsen, 80 mg, SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Fixed-dose Period: HAE-nC1-INH
n=3 participants at risk
Participants with HAE-nC1-INH who received placebo in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 4 Weeks)
n=13 participants at risk
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 8 Weeks)
n=8 participants at risk
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 8 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 100 mg Every 4 Weeks)
n=1 participants at risk
Participants with HAE-1/HAE-2 who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen 100 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 80 mg Every 4 Weeks)
n=1 participants at risk
Participants with HAE-nC1-INH who were attack free for ≥12 weeks after entering the OLE study received donidalorsen, 80 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 100 mg Every 4 Weeks)
n=2 participants at risk
Participants with HAE-nC1-INH who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen, 100 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
|---|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
100.0%
1/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
Other adverse events
| Measure |
Fixed-dose Period: HAE-1/HAE-2
n=17 participants at risk
Participants with HAE-1/HAE-2 who received placebo or donidalorsen, 80 mg, SC once every 4 weeks, in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Fixed-dose Period: HAE-nC1-INH
n=3 participants at risk
Participants with HAE-nC1-INH who received placebo in the previous study ISIS 721744-CS2 (NCT04030598), received donidalorsen, 80 mg, SC once every 4 weeks, from Week 1 to Week 13 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 4 Weeks)
n=13 participants at risk
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 80 mg Every 8 Weeks)
n=8 participants at risk
Participants with HAE-1/HAE-2 who were attack free for ≥12 weeks after entering the OLE study received donidalorsen 80 mg, every 8 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-1/HAE-2 (Donidalorsen 100 mg Every 4 Weeks)
n=1 participants at risk
Participants with HAE-1/HAE-2 who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen 100 mg, every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 80 mg Every 4 Weeks)
n=1 participants at risk
Participants with HAE-nC1-INH who were attack free for ≥12 weeks after entering the OLE study received donidalorsen, 80 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
Flexible-dose Period: HAE-nC1-INH (Donidalorsen 100 mg Every 4 Weeks)
n=2 participants at risk
Participants with HAE-nC1-INH who were not attack free for ≥12 weeks after entering the OLE study received donidalorsen, 100 mg, SC every 4 weeks, from Week 17 to Week 209 in this study.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
11.8%
2/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
38.5%
5/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
37.5%
3/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
100.0%
1/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Influenza
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
25.0%
2/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
33.3%
1/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
100.0%
1/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Chlamydial infection
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
100.0%
1/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Psychiatric disorders
Emotional distress
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
100.0%
1/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Psychiatric disorders
Seasonal affective disorder
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Toung Disorder
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Fatigue
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Vascular disorders
Flushing
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
50.0%
1/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Pyrexia
|
11.8%
2/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Injection site erythema
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Injection site irritation
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Injection site pruritus
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Axillary pain
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
33.3%
1/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Injection site pain
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
33.3%
1/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Tenderness
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
33.3%
1/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
2/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
33.3%
1/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Nausea
|
11.8%
2/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
33.3%
1/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
100.0%
1/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
33.3%
1/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Investigations
Platelet count decreased
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Renal and urinary disorders
Bladder pain
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord inflammation
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.9%
1/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
33.3%
1/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
23.1%
3/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Abscess
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Groin infection
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Otitis media
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
25.0%
2/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Root canal infection
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
100.0%
1/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
100.0%
1/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Injection site reaction
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Chills
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Injection site discolouration
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
100.0%
1/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Injection site dryness
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Injection site haematoma
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Injection site swelling
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Pain
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Peripheral swelling
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
General disorders
Injection site induration
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
100.0%
1/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
100.0%
1/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
23.1%
3/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
15.4%
2/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
100.0%
1/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Psychiatric disorders
Stress
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Injury, poisoning and procedural complications
Osteochondral fracture
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Investigations
Weight decreased
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Investigations
Blood urea increased
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
7.7%
1/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/17 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/3 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/13 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
12.5%
1/8 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/1 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
0.00%
0/2 • Up to Week 221
The safety population included all enrolled participants who received at least 1 dose in the OLE study.
|
Additional Information
Ionis Pharmaceuticals, Inc.
Ionis Pharmaceuticals, Inc.
Phone: 760-603-2346
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER