Trial Outcomes & Findings for A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN) (NCT NCT03841448)
NCT ID: NCT03841448
Last Updated: 2024-08-09
Results Overview
UPCR is a way of assessing the amount of protein in the urine. The primary analysis for UPCR was performed using Mixed-Effect Model Repeated Measures (MMRM) approach. Geometric mean (GM)ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed 24h UPCR. Standard error of the mean (SEM) was calculated as exponential (mean of change in log-transformed data) \* (standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% confidence interval (CIs) were calculated by exponentially back-transforming the model-based least square (LS) mean and the corresponding 90% CI.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Baseline to Week 32
Results posted on
2024-08-09
Participant Flow
Participants were enrolled in the study at 19 investigative centers in Canada, France, Malaysia, Philippines, Singapore, Spain, Sweden, Taiwan, and the United Kingdom from 30 Sept 2019 to 27 June 2023.
A total of 31 participants were enrolled in this study to receive cemdisiran or placebo. This study has two parts: Double Blind Treatment (DBT) Period and Open-Label Extension (OLE) Period.
Participant milestones
| Measure |
DBT Period: Placebo
Participants received cemdisiran matching placebo, subcutaneous (SC) injection, once every 4 weeks (Q4W) in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Cemdisiran
Participants received cemdisiran, 600 milligrams (mg), SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Placebo to OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period.
|
DBT Period: Cemdisiran to OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period.
|
|---|---|---|---|---|
|
Double-blind Treatment (DBT) Period
STARTED
|
9
|
22
|
0
|
0
|
|
Double-blind Treatment (DBT) Period
Modified Intent-to-treat (mITT) Analysis Set
|
9
|
22
|
0
|
0
|
|
Double-blind Treatment (DBT) Period
COMPLETED
|
8
|
21
|
0
|
0
|
|
Double-blind Treatment (DBT) Period
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Open-Label Extension (OLE) Period
STARTED
|
0
|
0
|
8
|
20
|
|
Open-Label Extension (OLE) Period
COMPLETED
|
0
|
0
|
0
|
0
|
|
Open-Label Extension (OLE) Period
NOT COMPLETED
|
0
|
0
|
8
|
20
|
Reasons for withdrawal
| Measure |
DBT Period: Placebo
Participants received cemdisiran matching placebo, subcutaneous (SC) injection, once every 4 weeks (Q4W) in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Cemdisiran
Participants received cemdisiran, 600 milligrams (mg), SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Placebo to OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period.
|
DBT Period: Cemdisiran to OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period.
|
|---|---|---|---|---|
|
Double-blind Treatment (DBT) Period
Death
|
1
|
1
|
0
|
0
|
|
Open-Label Extension (OLE) Period
Adverse Event
|
0
|
0
|
1
|
2
|
|
Open-Label Extension (OLE) Period
Death
|
0
|
0
|
0
|
1
|
|
Open-Label Extension (OLE) Period
Physician Decision
|
0
|
0
|
1
|
3
|
|
Open-Label Extension (OLE) Period
Study termination by Sponsor
|
0
|
0
|
4
|
9
|
|
Open-Label Extension (OLE) Period
Other Reason Not Specified
|
0
|
0
|
2
|
5
|
Baseline Characteristics
A Study of Cemdisiran in Adults With Immunoglobulin A Nephropathy (IgAN)
Baseline characteristics by cohort
| Measure |
DBT Period: Placebo
n=9 Participants
Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Cemdisiran
n=22 Participants
Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Urine Protein to Creatinine Ratio
|
1.972 g/g
STANDARD_DEVIATION 0.815 • n=5 Participants
|
1.554 g/g
STANDARD_DEVIATION 1.032 • n=7 Participants
|
1.676 g/g
STANDARD_DEVIATION 0.979 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 32Population: mITT Analysis Set included all participants who received any amount of study drug and had at least one post baseline 24-hour UPCR assessment. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
UPCR is a way of assessing the amount of protein in the urine. The primary analysis for UPCR was performed using Mixed-Effect Model Repeated Measures (MMRM) approach. Geometric mean (GM)ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed 24h UPCR. Standard error of the mean (SEM) was calculated as exponential (mean of change in log-transformed data) \* (standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% confidence interval (CIs) were calculated by exponentially back-transforming the model-based least square (LS) mean and the corresponding 90% CI.
Outcome measures
| Measure |
DBT Period: Placebo
n=9 Participants
Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Cemdisiran
n=22 Participants
Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Placebo + OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the OLE Period only, in which all participants were receiving treatment with cemdisiran.
|
DBT Period: Cemdisiran + OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the DBT and OLE Periods inclusively, in which all participants were receiving treatment with cemdisiran.
|
All Cemdisiran
All participants who received at least one dose of cemdisiran, including participants who received cemdisiran during the DB Period and participants who first received placebo during the DB Period and switched to cemdisiran during the OLE Period.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in UPCR as Measured in 24-hour Urine at Week 32
|
1.095 percent change
Standard Error 0.258
|
0.686 percent change
Standard Error 0.098
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 32Population: mITT Analysis Set included all participants who received any amount of study drug and had at least one post baseline 24-hour UPCR assessment. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Proteinuria is high levels of protein in the urine. 24-hour proteinuria assessment included 24-hour urine collections to assess total protein excretion per 24 hours. Analysis was performed using the MMRM model. GM ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed 24h urine protein (UP). SEM was calculated as exp (mean of change in log-transformed data) \*(standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% CIs are calculated by exponentially back-transforming the model-based LS Means and the corresponding 90% CI.
Outcome measures
| Measure |
DBT Period: Placebo
n=9 Participants
Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Cemdisiran
n=22 Participants
Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Placebo + OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the OLE Period only, in which all participants were receiving treatment with cemdisiran.
|
DBT Period: Cemdisiran + OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the DBT and OLE Periods inclusively, in which all participants were receiving treatment with cemdisiran.
|
All Cemdisiran
All participants who received at least one dose of cemdisiran, including participants who received cemdisiran during the DB Period and participants who first received placebo during the DB Period and switched to cemdisiran during the OLE Period.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in 24-hour Proteinuria at Week 32
|
1.051 percent change
Standard Error 0.266
|
0.671 percent change
Standard Error 0.104
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 32Population: mITT Analysis Set included all participants who received any amount of study drug and had at least one post baseline 24-hour UPCR assessment.
Partial clinical remission was defined as having UP \<1.0 g/24-hours.
Outcome measures
| Measure |
DBT Period: Placebo
n=9 Participants
Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Cemdisiran
n=22 Participants
Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Placebo + OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the OLE Period only, in which all participants were receiving treatment with cemdisiran.
|
DBT Period: Cemdisiran + OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the DBT and OLE Periods inclusively, in which all participants were receiving treatment with cemdisiran.
|
All Cemdisiran
All participants who received at least one dose of cemdisiran, including participants who received cemdisiran during the DB Period and participants who first received placebo during the DB Period and switched to cemdisiran during the OLE Period.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Partial Clinical Remission at Week 32
|
0 percentage of participants
|
22.7 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 32Population: mITT Analysis Set included all participants who received any amount of study drug and had at least one post baseline 24-hour UPCR assessment. Percentages are rounded off to the nearest decimal point.
Outcome measures
| Measure |
DBT Period: Placebo
n=9 Participants
Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Cemdisiran
n=22 Participants
Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Placebo + OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the OLE Period only, in which all participants were receiving treatment with cemdisiran.
|
DBT Period: Cemdisiran + OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the DBT and OLE Periods inclusively, in which all participants were receiving treatment with cemdisiran.
|
All Cemdisiran
All participants who received at least one dose of cemdisiran, including participants who received cemdisiran during the DB Period and participants who first received placebo during the DB Period and switched to cemdisiran during the OLE Period.
|
|---|---|---|---|---|---|
|
Percentage of Participants With >50% Reduction in 24-hour Proteinuria at Week 32
|
0 percentage of participants
|
22.7 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 32Population: mITT Analysis Set included all participants who received any amount of study drug and had at least one post baseline 24-hour UPCR assessment. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
UPCR was calculated by dividing the level of protein in a spot urine test by the creatinine level. Analysis was performed using MMRM model. GM ratios were obtained by exponentially back-transforming the arithmetic mean of change in log-transformed spot UPCR. SEM was calculated as exp (mean of change in log-transformed data) \*(standard error of change in log-transformed data). Adjusted GM ratio to baseline and 90% CIs are calculated by exponentially back-transforming the model-based LS Means and the corresponding 90% CI.
Outcome measures
| Measure |
DBT Period: Placebo
n=9 Participants
Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Cemdisiran
n=22 Participants
Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Placebo + OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the OLE Period only, in which all participants were receiving treatment with cemdisiran.
|
DBT Period: Cemdisiran + OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the DBT and OLE Periods inclusively, in which all participants were receiving treatment with cemdisiran.
|
All Cemdisiran
All participants who received at least one dose of cemdisiran, including participants who received cemdisiran during the DB Period and participants who first received placebo during the DB Period and switched to cemdisiran during the OLE Period.
|
|---|---|---|---|---|---|
|
Change From Baseline in UPCR as Measured in a Spot Urine at Week 32
|
1.344 gram per gram (g/g)
Standard Error 0.139
|
0.729 gram per gram (g/g)
Standard Error 0.109
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 32Population: mITT Analysis Set included all participants who received any amount of study drug and had at least one post-baseline 24-hour UPCR assessment. Overall number of participants analyzed is the number of participants with data available for analysis.
Hematuria is the presence of blood in the urine. Hematuria from spot urine collections was evaluated to assess the effect of cemdisiran on disease course in participants. The degree of hematuria was assessed by microscopic examination of the spun urine sediment (red blood cell (RBC)/ high power field \[hpf\]) and by urine dipstick.
Outcome measures
| Measure |
DBT Period: Placebo
n=8 Participants
Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Cemdisiran
n=20 Participants
Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Placebo + OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the OLE Period only, in which all participants were receiving treatment with cemdisiran.
|
DBT Period: Cemdisiran + OLE Period: Cemdisiran
Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the DBT and OLE Periods inclusively, in which all participants were receiving treatment with cemdisiran.
|
All Cemdisiran
All participants who received at least one dose of cemdisiran, including participants who received cemdisiran during the DB Period and participants who first received placebo during the DB Period and switched to cemdisiran during the OLE Period.
|
|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline in Hematuria at Week 32
Post-Baseline Category: Negative
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Change From Baseline in Hematuria at Week 32
Post-Baseline Category: Small
|
2 Participants
|
11 Participants
|
—
|
—
|
—
|
|
Number of Participants With Change From Baseline in Hematuria at Week 32
Post-Baseline Category: Moderate
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Change From Baseline in Hematuria at Week 32
Post-Baseline Category: Large
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 126 weeksPopulation: DBT Period: Safety Analysis Set: All participants who received any amount of study drug. DBT + OLE and All Cemdisiran: All Cemdisiran Treated Set: All participants who received at least one dose of cemdisiran, including participants who received cemdisiran during the DB Period and participants who first take placebo during the DB Period and switch to cemdisiran during the OLE Period.
An AE is any untoward medical occurrence in a participant or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
DBT Period: Placebo
n=9 Participants
Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Cemdisiran
n=22 Participants
Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Placebo + OLE Period: Cemdisiran
n=8 Participants
Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the OLE Period only, in which all participants were receiving treatment with cemdisiran.
|
DBT Period: Cemdisiran + OLE Period: Cemdisiran
n=22 Participants
Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the DBT and OLE Periods inclusively, in which all participants were receiving treatment with cemdisiran.
|
All Cemdisiran
n=30 Participants
All participants who received at least one dose of cemdisiran, including participants who received cemdisiran during the DB Period and participants who first received placebo during the DB Period and switched to cemdisiran during the OLE Period.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
8 Participants
|
19 Participants
|
8 Participants
|
22 Participants
|
30 Participants
|
Adverse Events
DBT Period: Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 1 deaths
DBT Period: Cemdisiran
Serious events: 1 serious events
Other events: 19 other events
Deaths: 1 deaths
DBT Period: Placebo + OLE Period: Cemdisiran
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
DBT Period: Cemdisiran + OLE Period: Cemdisiran
Serious events: 2 serious events
Other events: 22 other events
Deaths: 1 deaths
All Cemdisiran
Serious events: 5 serious events
Other events: 30 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
DBT Period: Placebo
n=9 participants at risk
Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Cemdisiran
n=22 participants at risk
Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Placebo + OLE Period: Cemdisiran
n=8 participants at risk
Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the OLE Period only, in which all participants were receiving treatment with cemdisiran.
|
DBT Period: Cemdisiran + OLE Period: Cemdisiran
n=22 participants at risk
Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the DBT and OLE Periods inclusively, in which all participants were receiving treatment with cemdisiran.
|
All Cemdisiran
n=30 participants at risk
All participants who received at least one dose of cemdisiran, including participants who received cemdisiran during the DB Period and participants who first received placebo during the DB Period and switched to cemdisiran during the OLE Period.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardiopulmonary failure
|
—
0/0 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
100.0%
1/1 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/1 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
Other adverse events
| Measure |
DBT Period: Placebo
n=9 participants at risk
Participants received cemdisiran matching placebo, SC injection, Q4W in combination with standard of care up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Cemdisiran
n=22 participants at risk
Participants received cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 38 weeks in the DBT period.
|
DBT Period: Placebo + OLE Period: Cemdisiran
n=8 participants at risk
Participants who were randomized to receive cemdisiran matching placebo in the DBT period started receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the OLE Period only, in which all participants were receiving treatment with cemdisiran.
|
DBT Period: Cemdisiran + OLE Period: Cemdisiran
n=22 participants at risk
Participants who were randomized to receive cemdisiran in the DBT period continued receiving cemdisiran, 600 mg, SC injection, Q4W in combination with standard of care treatment up to a maximum of 88 weeks in the OLE treatment period. The data reported for this group is for the DBT and OLE Periods inclusively, in which all participants were receiving treatment with cemdisiran.
|
All Cemdisiran
n=30 participants at risk
All participants who received at least one dose of cemdisiran, including participants who received cemdisiran during the DB Period and participants who first received placebo during the DB Period and switched to cemdisiran during the OLE Period.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
10.0%
3/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
10.0%
3/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Asthenia
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
2/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Investigations
Blood pressure increased
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
62.5%
5/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
40.9%
9/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
46.7%
14/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic eczema
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Vascular disorders
Hot flush
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
25.0%
2/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
25.0%
2/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
10.0%
3/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Influenza
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Injection site bruising
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Injection site reaction
|
22.2%
2/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
40.9%
9/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
62.5%
5/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
40.9%
9/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
46.7%
14/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Injection site recall reaction
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
37.5%
3/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
16.7%
5/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Ear and labyrinth disorders
Keratosis obturans
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Nervous system disorders
Migraine
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
3/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
25.0%
2/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
10.0%
3/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
13.6%
3/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
13.6%
3/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
13.3%
4/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Pain
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
25.0%
2/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
13.6%
3/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
16.7%
5/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
13.6%
3/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
13.3%
4/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Nervous system disorders
Restless legs syndrome
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Suprapubic pain
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
18.2%
4/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
13.3%
4/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
13.6%
3/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
10.0%
3/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Vaccination site reaction
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
11.1%
1/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Investigations
Weight increased
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Chest pain
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Feeling cold
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Influenza like illness
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Malaise
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
General disorders
Swelling face
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Immune system disorders
Milk allergy
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Cystitis
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Superinfection
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Viral infection
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Infections and infestations
Viral rash
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
9.1%
2/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Investigations
Gamma-glutamyltransferase abnormal
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Investigations
Liver function test increased
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Investigations
Urine sodium increased
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Psychiatric disorders
insomnia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
12.5%
1/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
25.0%
2/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
6.7%
2/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
0.00%
0/8 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
4.5%
1/22 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
3.3%
1/30 • DBT Period: from the first dose of study drug up to 38 weeks. OLE Period: from Week 38 up to 88 weeks (up to 126 weeks for both periods combined). All Cemdisiran: from the first dose of study drug up to 126 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place