Trial Outcomes & Findings for Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD) (NCT NCT03385239)
NCT ID: NCT03385239
Last Updated: 2023-01-11
Results Overview
An analysis of covariance (ANCOVA) model was performed on the log ratio of TG value at the Primary Analysis Time Point to TG value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: (ratio of TG value at the Primary Analysis Time Point to TG value at Baseline - 1) × 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
114 participants
Primary outcome timeframe
Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)
Results posted on
2023-01-11
Participant Flow
Participants with a clinical diagnosis of hypertriglyceridemia and established cardiovascular disease (CVD) or at high risk for CVD were enrolled in 32 study sites in United States and Canada between 30 January 2018 to 25 February 2020.
114 participants were randomized in a 1:1:1:1 ratio to Cohorts A, B, C or D. In each cohort, participants were randomized in a 4:1 ratio to receive ISIS 678354 or placebo. Placebo participants from all cohorts were pooled for analysis and presented as the pooled placebo group.
Participant milestones
| Measure |
Pooled Placebo
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
|
Cohort A: ISIS 678354: 10 mg Q4W
Cohort A participants received 10 milligrams (mg) ISIS 678354, subcutaneous (SC) injection, once every 4 weeks (Q4W), for up to 49 weeks and a maximum of 13 doses.
|
Cohort C: ISIS 678354: 15 mg Q2W
Cohort C participants received 15 mg ISIS 678354, SC injection, once every 2 weeks (Q2W) for up to 51 weeks and a maximum of 26 doses.
|
Cohort D: ISIS 678354: 10 mg QW
Cohort D participants received 10 mg ISIS 678354, SC injection, once weekly (QW) for up to 52 weeks and a maximum of 52 doses.
|
Cohort B: ISIS 678354: 50 mg Q4W
Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
22
|
23
|
23
|
22
|
|
Overall Study
COMPLETED
|
22
|
19
|
20
|
19
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
4
|
0
|
Reasons for withdrawal
| Measure |
Pooled Placebo
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
|
Cohort A: ISIS 678354: 10 mg Q4W
Cohort A participants received 10 milligrams (mg) ISIS 678354, subcutaneous (SC) injection, once every 4 weeks (Q4W), for up to 49 weeks and a maximum of 13 doses.
|
Cohort C: ISIS 678354: 15 mg Q2W
Cohort C participants received 15 mg ISIS 678354, SC injection, once every 2 weeks (Q2W) for up to 51 weeks and a maximum of 26 doses.
|
Cohort D: ISIS 678354: 10 mg QW
Cohort D participants received 10 mg ISIS 678354, SC injection, once weekly (QW) for up to 52 weeks and a maximum of 52 doses.
|
Cohort B: ISIS 678354: 50 mg Q4W
Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses.
|
|---|---|---|---|---|---|
|
Overall Study
Voluntary Withdrawal
|
2
|
3
|
2
|
3
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)
Baseline characteristics by cohort
| Measure |
Pooled Placebo
n=24 Participants
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
|
Cohort A: ISIS 678354: 10 mg Q4W
n=22 Participants
Cohort A participants received 10 mg ISIS 678354, SC injection, Q4W, for up to 49 weeks and a maximum of 13 doses.
|
Cohort C: ISIS 678354: 15 mg Q2W
n=23 Participants
Cohort C participants received 15 mg ISIS 678354, SC injection, Q2W for up to 51 weeks and a maximum of 26 doses.
|
Cohort D: ISIS 678354: 10 mg QW
n=23 Participants
Cohort D participants received 10 mg ISIS 678354, SC injection, QW for up to 52 weeks and a maximum of 52 doses.
|
Cohort B: ISIS 678354: 50 mg Q4W
n=22 Participants
Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 7.93 • n=99 Participants
|
64.4 years
STANDARD_DEVIATION 9.13 • n=107 Participants
|
68.9 years
STANDARD_DEVIATION 6.82 • n=206 Participants
|
65.6 years
STANDARD_DEVIATION 8.48 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 7.40 • n=31 Participants
|
65.3 years
STANDARD_DEVIATION 8.10 • n=30 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
28 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
86 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
107 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
106 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Fasting Triglycerides (TG)
|
293.8 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 86.68 • n=99 Participants
|
281.6 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 73.43 • n=107 Participants
|
284.8 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 94.54 • n=206 Participants
|
292.3 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 89.29 • n=7 Participants
|
268.4 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 85.08 • n=31 Participants
|
284.4 milligrams per deciliter (mg/dL)
STANDARD_DEVIATION 85.16 • n=30 Participants
|
|
Apolipoprotein CIII (ApoC-III)
|
16.618 mg/dL
STANDARD_DEVIATION 4.4720 • n=99 Participants
|
16.030 mg/dL
STANDARD_DEVIATION 4.1482 • n=107 Participants
|
15.849 mg/dL
STANDARD_DEVIATION 4.2456 • n=206 Participants
|
16.810 mg/dL
STANDARD_DEVIATION 4.2021 • n=7 Participants
|
15.669 mg/dL
STANDARD_DEVIATION 3.2484 • n=31 Participants
|
16.205 mg/dL
STANDARD_DEVIATION 4.0466 • n=30 Participants
|
|
Total Cholesterol (TC)
|
144.8 mg/dL
STANDARD_DEVIATION 26.00 • n=99 Participants
|
149.2 mg/dL
STANDARD_DEVIATION 28.81 • n=107 Participants
|
163.1 mg/dL
STANDARD_DEVIATION 35.09 • n=206 Participants
|
160.0 mg/dL
STANDARD_DEVIATION 34.55 • n=7 Participants
|
166.8 mg/dL
STANDARD_DEVIATION 35.30 • n=31 Participants
|
156.7 mg/dL
STANDARD_DEVIATION 32.66 • n=30 Participants
|
|
LDL Cholesterol (LDL-C)
|
55.9 mg/dL
STANDARD_DEVIATION 26.06 • n=99 Participants
|
62.4 mg/dL
STANDARD_DEVIATION 22.57 • n=107 Participants
|
73.1 mg/dL
STANDARD_DEVIATION 29.73 • n=206 Participants
|
71.2 mg/dL
STANDARD_DEVIATION 30.24 • n=7 Participants
|
74.8 mg/dL
STANDARD_DEVIATION 22.47 • n=31 Participants
|
67.4 mg/dL
STANDARD_DEVIATION 27.02 • n=30 Participants
|
|
HDL Cholesterol (HDL-C)
|
34.6 mg/dL
STANDARD_DEVIATION 8.61 • n=99 Participants
|
34.1 mg/dL
STANDARD_DEVIATION 9.07 • n=107 Participants
|
33.9 mg/dL
STANDARD_DEVIATION 9.48 • n=206 Participants
|
34.8 mg/dL
STANDARD_DEVIATION 8.61 • n=7 Participants
|
36.8 mg/dL
STANDARD_DEVIATION 10.54 • n=31 Participants
|
34.8 mg/dL
STANDARD_DEVIATION 9.16 • n=30 Participants
|
|
Non-HDL Cholesterol (Non-HDL-C)
|
110.3 mg/dL
STANDARD_DEVIATION 23.96 • n=99 Participants
|
115.1 mg/dL
STANDARD_DEVIATION 28.93 • n=107 Participants
|
129.2 mg/dL
STANDARD_DEVIATION 33.32 • n=206 Participants
|
125.3 mg/dL
STANDARD_DEVIATION 32.09 • n=7 Participants
|
130.1 mg/dL
STANDARD_DEVIATION 31.02 • n=31 Participants
|
121.9 mg/dL
STANDARD_DEVIATION 30.52 • n=30 Participants
|
|
VLDL Cholesterol (VLDL-C)
|
54.9 mg/dL
STANDARD_DEVIATION 12.71 • n=99 Participants
|
54.0 mg/dL
STANDARD_DEVIATION 10.99 • n=107 Participants
|
56.1 mg/dL
STANDARD_DEVIATION 21.45 • n=206 Participants
|
54.1 mg/dL
STANDARD_DEVIATION 11.80 • n=7 Participants
|
55.2 mg/dL
STANDARD_DEVIATION 26.84 • n=31 Participants
|
54.9 mg/dL
STANDARD_DEVIATION 17.51 • n=30 Participants
|
|
Apolipoprotein B (ApoB)
|
77.1 mg/dL
STANDARD_DEVIATION 19.71 • n=99 Participants
|
79.6 mg/dL
STANDARD_DEVIATION 16.55 • n=107 Participants
|
87.9 mg/dL
STANDARD_DEVIATION 20.60 • n=206 Participants
|
86.8 mg/dL
STANDARD_DEVIATION 19.62 • n=7 Participants
|
88.5 mg/dL
STANDARD_DEVIATION 14.29 • n=31 Participants
|
83.9 mg/dL
STANDARD_DEVIATION 18.65 • n=30 Participants
|
|
Apolipoprotein A1 (ApoA-I)
|
131.4 mg/dL
STANDARD_DEVIATION 19.28 • n=99 Participants
|
130.2 mg/dL
STANDARD_DEVIATION 19.15 • n=107 Participants
|
129.0 mg/dL
STANDARD_DEVIATION 16.69 • n=206 Participants
|
132.5 mg/dL
STANDARD_DEVIATION 22.95 • n=7 Participants
|
136.3 mg/dL
STANDARD_DEVIATION 23.07 • n=31 Participants
|
131.9 mg/dL
STANDARD_DEVIATION 20.14 • n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)Population: FAS included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo). Here, 'Number analyzed' ('n') = Participants evaluable for this outcome measure at the specified timepoint.
An analysis of covariance (ANCOVA) model was performed on the log ratio of TG value at the Primary Analysis Time Point to TG value at Baseline. The estimate of the log ratio was converted back to the original scale and percent change was calculated using formula: (ratio of TG value at the Primary Analysis Time Point to TG value at Baseline - 1) × 100.
Outcome measures
| Measure |
Pooled Placebo
n=24 Participants
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
|
Cohort A: ISIS 678354: 10 mg Q4W
n=22 Participants
Cohort A participants received 10 mg ISIS 678354, SC injection, Q4W, for up to 49 weeks and a maximum of 13 doses.
|
Cohort C: ISIS 678354: 15 mg Q2W
n=23 Participants
Cohort C participants received 15 mg ISIS 678354, SC injection, Q2W for up to 51 weeks and a maximum of 26 doses.
|
Cohort D: ISIS 678354: 10 mg QW
n=23 Participants
Cohort D participants received 10 mg ISIS 678354, SC injection, QW for up to 52 weeks and a maximum of 52 doses.
|
Cohort B: ISIS 678354: 50 mg Q4W
n=22 Participants
Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides (TG) at the Primary Analysis Time Point
|
6 percent change
Interval -9.0 to 23.0
|
-23 percent change
Interval -34.0 to -10.0
|
-56 percent change
Interval -62.0 to -49.0
|
-60 percent change
Interval -66.0 to -54.0
|
-60 percent change
Interval -65.0 to -53.0
|
PRIMARY outcome
Timeframe: Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)Population: Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
An adverse event (AE) was defined as any unfavorable and unintended sign (including a clinically-significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE was considered to be related to the investigational drug product. A TEAE was defined as any AE starting on or after the first dose of the study drug.
Outcome measures
| Measure |
Pooled Placebo
n=24 Participants
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
|
Cohort A: ISIS 678354: 10 mg Q4W
n=22 Participants
Cohort A participants received 10 mg ISIS 678354, SC injection, Q4W, for up to 49 weeks and a maximum of 13 doses.
|
Cohort C: ISIS 678354: 15 mg Q2W
n=23 Participants
Cohort C participants received 15 mg ISIS 678354, SC injection, Q2W for up to 51 weeks and a maximum of 26 doses.
|
Cohort D: ISIS 678354: 10 mg QW
n=23 Participants
Cohort D participants received 10 mg ISIS 678354, SC injection, QW for up to 52 weeks and a maximum of 52 doses.
|
Cohort B: ISIS 678354: 50 mg Q4W
n=22 Participants
Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
20 Participants
|
17 Participants
|
20 Participants
|
22 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)Population: FAS included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo). Here, 'Number analyzed' ('n') = Participants evaluable for this outcome measure for each specified category.
An ANCOVA model was performed on the log ratio of Primary Analysis Time Point value to Baseline value for ApoC-III, TC, LDL-C, HDL-C, Non-HDL-C, VLDL-C, ApoB, and ApoA-I. The estimate of the log ratio was converted back to the original scale and percent change for each lipid parameter was calculated using formula: (ratio of Primary Analysis Time Point value to Baseline value - 1) × 100.
Outcome measures
| Measure |
Pooled Placebo
n=24 Participants
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
|
Cohort A: ISIS 678354: 10 mg Q4W
n=22 Participants
Cohort A participants received 10 mg ISIS 678354, SC injection, Q4W, for up to 49 weeks and a maximum of 13 doses.
|
Cohort C: ISIS 678354: 15 mg Q2W
n=23 Participants
Cohort C participants received 15 mg ISIS 678354, SC injection, Q2W for up to 51 weeks and a maximum of 26 doses.
|
Cohort D: ISIS 678354: 10 mg QW
n=23 Participants
Cohort D participants received 10 mg ISIS 678354, SC injection, QW for up to 52 weeks and a maximum of 52 doses.
|
Cohort B: ISIS 678354: 50 mg Q4W
n=22 Participants
Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in ApoC-III, TC, LDL-C, HDL-C, Non-HDL-C, VLDL-C, ApoB, and ApoA-I at the Primary Analysis Time Point
Apo-C III
|
2 percent change
Interval -16.0 to 23.0
|
-29 percent change
Interval -42.0 to -13.0
|
-68 percent change
Interval -74.0 to -61.0
|
-73 percent change
Interval -78.0 to -67.0
|
-74 percent change
Interval -78.0 to -69.0
|
|
Percent Change From Baseline in ApoC-III, TC, LDL-C, HDL-C, Non-HDL-C, VLDL-C, ApoB, and ApoA-I at the Primary Analysis Time Point
TC
|
1 percent change
Interval -6.0 to 7.0
|
-2 percent change
Interval -8.0 to 5.0
|
-12 percent change
Interval -17.0 to -5.0
|
-3 percent change
Interval -9.0 to 4.0
|
-8 percent change
Interval -13.0 to -2.0
|
|
Percent Change From Baseline in ApoC-III, TC, LDL-C, HDL-C, Non-HDL-C, VLDL-C, ApoB, and ApoA-I at the Primary Analysis Time Point
LDL-C
|
-2 percent change
Interval -13.0 to 11.0
|
5 percent change
Interval -7.0 to 19.0
|
2 percent change
Interval -10.0 to 15.0
|
27 percent change
Interval 13.0 to 44.0
|
10 percent change
Interval -2.0 to 23.0
|
|
Percent Change From Baseline in ApoC-III, TC, LDL-C, HDL-C, Non-HDL-C, VLDL-C, ApoB, and ApoA-I at the Primary Analysis Time Point
HDL-C
|
-1 percent change
Interval -8.0 to 6.0
|
11 percent change
Interval 3.0 to 19.0
|
33 percent change
Interval 24.0 to 43.0
|
40 percent change
Interval 30.0 to 51.0
|
29 percent change
Interval 20.0 to 39.0
|
|
Percent Change From Baseline in ApoC-III, TC, LDL-C, HDL-C, Non-HDL-C, VLDL-C, ApoB, and ApoA-I at the Primary Analysis Time Point
Non-HDL-C
|
1 percent change
Interval -8.0 to 10.0
|
-6 percent change
Interval -15.0 to 3.0
|
-24 percent change
Interval -31.0 to -17.0
|
-15 percent change
Interval -23.0 to -7.0
|
-19 percent change
Interval -26.0 to -12.0
|
|
Percent Change From Baseline in ApoC-III, TC, LDL-C, HDL-C, Non-HDL-C, VLDL-C, ApoB, and ApoA-I at the Primary Analysis Time Point
VLDL-C
|
-2 percent change
Interval -13.0 to 11.0
|
-22 percent change
Interval -32.0 to -12.0
|
-54 percent change
Interval -59.0 to -48.0
|
-59 percent change
Interval -63.0 to -53.0
|
-60 percent change
Interval -65.0 to -55.0
|
|
Percent Change From Baseline in ApoC-III, TC, LDL-C, HDL-C, Non-HDL-C, VLDL-C, ApoB, and ApoA-I at the Primary Analysis Time Point
ApoB
|
-2 percent change
Interval -8.0 to 5.0
|
0 percent change
Interval -7.0 to 8.0
|
-17 percent change
Interval -23.0 to -12.0
|
-7 percent change
Interval -13.0 to 0.0
|
-12 percent change
Interval -18.0 to -6.0
|
|
Percent Change From Baseline in ApoC-III, TC, LDL-C, HDL-C, Non-HDL-C, VLDL-C, ApoB, and ApoA-I at the Primary Analysis Time Point
ApoA-1
|
0 percent change
Interval -4.0 to 4.0
|
5 percent change
Interval 1.0 to 10.0
|
14 percent change
Interval 9.0 to 19.0
|
18 percent change
Interval 13.0 to 23.0
|
14 percent change
Interval 9.0 to 18.0
|
SECONDARY outcome
Timeframe: Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)Population: FAS included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
The percentage of participants who achieved \<= 150 mg/dL or \<= 1.7 mmol/L of fasting TG levels at the primary analysis time point were compared between each ISIS 678354 treatment group and pooled placebo group using a logistic regression model with log-transformed baseline TG value as a covariate.
Outcome measures
| Measure |
Pooled Placebo
n=24 Participants
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
|
Cohort A: ISIS 678354: 10 mg Q4W
n=22 Participants
Cohort A participants received 10 mg ISIS 678354, SC injection, Q4W, for up to 49 weeks and a maximum of 13 doses.
|
Cohort C: ISIS 678354: 15 mg Q2W
n=23 Participants
Cohort C participants received 15 mg ISIS 678354, SC injection, Q2W for up to 51 weeks and a maximum of 26 doses.
|
Cohort D: ISIS 678354: 10 mg QW
n=23 Participants
Cohort D participants received 10 mg ISIS 678354, SC injection, QW for up to 52 weeks and a maximum of 52 doses.
|
Cohort B: ISIS 678354: 50 mg Q4W
n=22 Participants
Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Fasting Triglycerides (TG) <= 150 mg/dL (<= 1.7 Millimoles Per Liter [mmol/L])
|
4.2 percentage of participants
|
13.6 percentage of participants
|
65.2 percentage of participants
|
73.9 percentage of participants
|
90.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 6 (Week 25 for Cohorts A and B and Week 27 for Cohorts C and D)Population: FAS included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
The percentage of participants who achieved \<= 100 mg/dL or \<= 1.13 mmol/L of fasting TG levels at the primary analysis time point were compared between each ISIS 678354 treatment group and pooled placebo group using a logistic regression model with log-transformed baseline TG value as a covariate.
Outcome measures
| Measure |
Pooled Placebo
n=24 Participants
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
|
Cohort A: ISIS 678354: 10 mg Q4W
n=22 Participants
Cohort A participants received 10 mg ISIS 678354, SC injection, Q4W, for up to 49 weeks and a maximum of 13 doses.
|
Cohort C: ISIS 678354: 15 mg Q2W
n=23 Participants
Cohort C participants received 15 mg ISIS 678354, SC injection, Q2W for up to 51 weeks and a maximum of 26 doses.
|
Cohort D: ISIS 678354: 10 mg QW
n=23 Participants
Cohort D participants received 10 mg ISIS 678354, SC injection, QW for up to 52 weeks and a maximum of 52 doses.
|
Cohort B: ISIS 678354: 50 mg Q4W
n=22 Participants
Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses.
|
|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Fasting Triglycerides (TG) <= 100 mg/dL (<= 1.13 mmol/L)
|
0 percentage of participants
|
0 percentage of participants
|
30.4 percentage of participants
|
26.1 percentage of participants
|
45.5 percentage of participants
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 8, 24 hours post the first dose (Day 1), Week 21 (for Cohorts A and B) and Week 25 (for Cohorts C and D)Population: Pharmacokinetic (PK) subgroup: Subset of participants who were randomized, received at least (\>=) 1 dose of ISIS 678354, had \>= 1 evaluable concentration result post first dose and had additional PK sampling after dose administration on Day 1 and Week 21 (Cohorts A and B) or Week 25 (Cohorts C and D). 'Number analyzed' = participants evaluable for this outcome measure at specified time points.
Outcome measures
| Measure |
Pooled Placebo
n=5 Participants
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
|
Cohort A: ISIS 678354: 10 mg Q4W
n=8 Participants
Cohort A participants received 10 mg ISIS 678354, SC injection, Q4W, for up to 49 weeks and a maximum of 13 doses.
|
Cohort C: ISIS 678354: 15 mg Q2W
n=4 Participants
Cohort C participants received 15 mg ISIS 678354, SC injection, Q2W for up to 51 weeks and a maximum of 26 doses.
|
Cohort D: ISIS 678354: 10 mg QW
n=2 Participants
Cohort D participants received 10 mg ISIS 678354, SC injection, QW for up to 52 weeks and a maximum of 52 doses.
|
Cohort B: ISIS 678354: 50 mg Q4W
Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses.
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of ISIS 678354
Day 1
|
53.7 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 181.2
|
45.9 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 36.2
|
35.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 71.1
|
48.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 333.3
|
—
|
|
Maximum Plasma Concentration (Cmax) of ISIS 678354
Week 21 (for Cohorts A and B) and Week 25 (for Cohorts C and D)
|
41.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 324.1
|
48.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 29.9
|
45.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 47.4
|
127 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 29.9
|
—
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 8, 24 hours post the first dose (Day 1), Week 21 (for Cohorts A and B) and Week 25 (for Cohorts C and D)Population: PK subgroup: Subset of participants who were randomized, received \>= 1 dose of ISIS 678354, had \>= 1 evaluable concentration result post first dose and had additional PK sampling after dose administration on Day 1 and Week 21 (Cohorts A and B) or Week 25 (Cohorts C and D). 'Number analyzed' = participants evaluable for this outcome measure at specified time points.
Outcome measures
| Measure |
Pooled Placebo
n=5 Participants
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
|
Cohort A: ISIS 678354: 10 mg Q4W
n=8 Participants
Cohort A participants received 10 mg ISIS 678354, SC injection, Q4W, for up to 49 weeks and a maximum of 13 doses.
|
Cohort C: ISIS 678354: 15 mg Q2W
n=4 Participants
Cohort C participants received 15 mg ISIS 678354, SC injection, Q2W for up to 51 weeks and a maximum of 26 doses.
|
Cohort D: ISIS 678354: 10 mg QW
n=2 Participants
Cohort D participants received 10 mg ISIS 678354, SC injection, QW for up to 52 weeks and a maximum of 52 doses.
|
Cohort B: ISIS 678354: 50 mg Q4W
Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of ISIS 678354
Day 1
|
1.08 hours (h)
Interval 1.0 to 2.0
|
2.00 hours (h)
Interval 1.98 to 4.0
|
3.03 hours (h)
Interval 2.0 to 4.0
|
1.50 hours (h)
Interval 1.05 to 1.95
|
—
|
|
Time to Reach Maximum Plasma Concentration (Tmax) of ISIS 678354
Week 21 (for Cohorts A and B) and Week 25 (for Cohorts C and D)
|
2.00 hours (h)
Interval 0.917 to 8.0
|
2.08 hours (h)
Interval 1.0 to 4.0
|
2.50 hours (h)
Interval 1.0 to 4.0
|
4.04 hours (h)
Interval 4.02 to 4.07
|
—
|
SECONDARY outcome
Timeframe: Predose, 1, 2, 4, 8, 24 hours post the first dose (Day 1), Week 21 (for Cohorts A and B) and Week 25 (for Cohorts C and D)Population: PK subgroup: Subset of participants who were randomized, received \>= 1 dose of ISIS 678354, had \>= 1 evaluable concentration result post first dose and had additional PK sampling after dose administration on Day 1 and Week 21 (Cohorts A and B) or Week 25 (Cohorts C and D). 'Number analyzed' = participants evaluable for this outcome measure at specified time points.
Outcome measures
| Measure |
Pooled Placebo
n=5 Participants
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
|
Cohort A: ISIS 678354: 10 mg Q4W
n=8 Participants
Cohort A participants received 10 mg ISIS 678354, SC injection, Q4W, for up to 49 weeks and a maximum of 13 doses.
|
Cohort C: ISIS 678354: 15 mg Q2W
n=4 Participants
Cohort C participants received 15 mg ISIS 678354, SC injection, Q2W for up to 51 weeks and a maximum of 26 doses.
|
Cohort D: ISIS 678354: 10 mg QW
n=2 Participants
Cohort D participants received 10 mg ISIS 678354, SC injection, QW for up to 52 weeks and a maximum of 52 doses.
|
Cohort B: ISIS 678354: 50 mg Q4W
Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses.
|
|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of ISIS 678354
Day 1
|
618 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 115.6
|
499 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 31.1
|
411 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 59.0
|
563 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 334.6
|
—
|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC0-24) of ISIS 678354
Week 21 (for Cohorts A and B) and Week 25 (for Cohorts C and D)
|
468 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 258.4
|
499 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 11.2
|
454 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 26.3
|
1460 nanograms*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 13.6
|
—
|
Adverse Events
Pooled Placebo
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Cohort A: ISIS 678354: 10 mg Q4W
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort C: ISIS 678354: 15 mg Q2W
Serious events: 4 serious events
Other events: 19 other events
Deaths: 1 deaths
Cohort D: ISIS 678354: 10 mg QW
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Cohort B: ISIS 678354: 50 mg Q4W
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pooled Placebo
n=24 participants at risk
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
|
Cohort A: ISIS 678354: 10 mg Q4W
n=22 participants at risk
Cohort A participants received 10 mg ISIS 678354, SC injection, Q4W, for up to 49 weeks and a maximum of 13 doses.
|
Cohort C: ISIS 678354: 15 mg Q2W
n=23 participants at risk
Cohort C participants received 15 mg ISIS 678354, SC injection, Q2W for up to 51 weeks and a maximum of 26 doses.
|
Cohort D: ISIS 678354: 10 mg QW
n=23 participants at risk
Cohort D participants received 10 mg ISIS 678354, SC injection, QW for up to 52 weeks and a maximum of 52 doses.
|
Cohort B: ISIS 678354: 50 mg Q4W
n=22 participants at risk
Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Infections and infestations
Influenza
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
General disorders
Asthenia
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Nervous system disorders
Post polio syndrome
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Nervous system disorders
Cerebral ischaemia
|
4.2%
1/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
4.2%
1/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
Other adverse events
| Measure |
Pooled Placebo
n=24 participants at risk
Participants in each cohort were randomized to receive placebo at a dose-matched volume of study drug (ISIS 678354).
|
Cohort A: ISIS 678354: 10 mg Q4W
n=22 participants at risk
Cohort A participants received 10 mg ISIS 678354, SC injection, Q4W, for up to 49 weeks and a maximum of 13 doses.
|
Cohort C: ISIS 678354: 15 mg Q2W
n=23 participants at risk
Cohort C participants received 15 mg ISIS 678354, SC injection, Q2W for up to 51 weeks and a maximum of 26 doses.
|
Cohort D: ISIS 678354: 10 mg QW
n=23 participants at risk
Cohort D participants received 10 mg ISIS 678354, SC injection, QW for up to 52 weeks and a maximum of 52 doses.
|
Cohort B: ISIS 678354: 50 mg Q4W
n=22 participants at risk
Cohort B participants received 50 mg ISIS 678354, SC injection, once Q4W for up to 49 weeks and a maximum of 13 doses.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
12.5%
3/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.6%
3/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
17.4%
4/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
21.7%
5/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
18.2%
4/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
3/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.0%
3/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
17.4%
4/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.6%
3/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Infections and infestations
Urinary tract infection
|
4.2%
1/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
18.2%
4/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Infections and infestations
Bronchitis
|
8.3%
2/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Infections and infestations
Sinusitis
|
4.2%
1/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.6%
3/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Infections and infestations
Ear infection
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.6%
3/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.0%
3/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.0%
3/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
1/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.6%
3/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.0%
3/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.6%
3/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
1/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
18.2%
4/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.3%
2/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.6%
3/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
4/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.0%
3/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
4.2%
1/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
General disorders
Injection site erythema
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.0%
3/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
21.7%
5/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
18.2%
4/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
General disorders
Fatigue
|
4.2%
1/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
General disorders
Non-cardiac chest pain
|
8.3%
2/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
General disorders
Injection site pruritus
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
General disorders
Oedema peripheral
|
8.3%
2/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
General disorders
Injection site haemorrhage
|
4.2%
1/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
General disorders
Injection site pain
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
General disorders
Influenza like illness
|
8.3%
2/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
General disorders
Pain
|
8.3%
2/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.6%
3/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
18.2%
4/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
2/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.6%
3/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.0%
3/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Vascular disorders
Hypertension
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.6%
3/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Vascular disorders
Hypotension
|
4.2%
1/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Investigations
Glomerular filtration rate decreased
|
8.3%
2/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Investigations
Haemoglobin decreased
|
8.3%
2/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
2/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.6%
3/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
8.3%
2/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
13.6%
3/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.5%
1/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Eye disorders
Cataract
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Eye disorders
Vision blurred
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Injury, poisoning and procedural complications
Contusion
|
4.2%
1/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
4.3%
1/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
9.1%
2/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/24 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
8.7%
2/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/23 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
0.00%
0/22 • Up to the 13-week post-treatment follow-up period (Up to approximately 15 months)
Safety set included all participants who were randomized and received at least 1 dose of study drug (ISIS 678354 or placebo).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60