Trial Outcomes & Findings for Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840 (NCT NCT04422431)
NCT ID: NCT04422431
Last Updated: 2024-10-18
Results Overview
Liver biopsy samples were taken for the assessment of liver Cu concentration. Multiple imputation was used to impute missing data at Week 48 due to any reason based on Baseline values.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Baseline, Week 48 (Treatment Period)
Results posted on
2024-10-18
Participant Flow
Participant milestones
| Measure |
ALXN1840
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
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|---|---|
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Treatment Period (48 Weeks)
STARTED
|
31
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|
Treatment Period (48 Weeks)
Received at Least 1 Dose of Study Drug
|
31
|
|
Treatment Period (48 Weeks)
COMPLETED
|
26
|
|
Treatment Period (48 Weeks)
NOT COMPLETED
|
5
|
|
Extension Period (48 Weeks)
STARTED
|
25
|
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Extension Period (48 Weeks)
Received at Least 1 Dose of Study Drug
|
25
|
|
Extension Period (48 Weeks)
COMPLETED
|
21
|
|
Extension Period (48 Weeks)
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
ALXN1840
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
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|---|---|
|
Treatment Period (48 Weeks)
Adverse Event
|
3
|
|
Treatment Period (48 Weeks)
Withdrawal by Subject
|
1
|
|
Treatment Period (48 Weeks)
Other than specified
|
1
|
|
Extension Period (48 Weeks)
Withdrawal by Subject
|
1
|
|
Extension Period (48 Weeks)
Lost to Follow-up
|
1
|
|
Extension Period (48 Weeks)
Other than specified
|
2
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Baseline Characteristics
Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840
Baseline characteristics by cohort
| Measure |
ALXN1840
n=29 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
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|---|---|
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Age, Continuous
|
37.9 years
STANDARD_DEVIATION 13.81 • n=99 Participants
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Sex: Female, Male
Female
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10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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23 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
Race · White
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19 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
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6 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
Race · Other
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3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
1 Participants
n=99 Participants
|
|
Liver Cu Concentration
|
511.2 micrograms (μg)/gram (g)
STANDARD_DEVIATION 361.85 • n=99 Participants
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|
Hepatic Collagen Content
|
10.2993 percentage of collagen
STANDARD_DEVIATION 6.81501 • n=99 Participants
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|
Alpha-Smooth Muscle Actin (a-SMA) Content
|
5.3134 percentage of a-SMA
STANDARD_DEVIATION 3.25982 • n=99 Participants
|
|
Hepatic Fat Content
|
1.5815 percentage of fat
STANDARD_DEVIATION 2.60491 • n=99 Participants
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Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) Total Score
|
1.2 units on a scale
STANDARD_DEVIATION 1.45 • n=99 Participants
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|
Molybdenum (Mo) in Liver Biopsy Specimen
|
4.1591 μg/g
STANDARD_DEVIATION 4.43552 • n=99 Participants
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|
Clinical Global Impression-Severity (CGI-S) Scale Score
|
2.3 units on a scale
STANDARD_DEVIATION 1.26 • n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 48 (Treatment Period)Population: The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver Cu value evaluable.
Liver biopsy samples were taken for the assessment of liver Cu concentration. Multiple imputation was used to impute missing data at Week 48 due to any reason based on Baseline values.
Outcome measures
| Measure |
ALXN1840
n=29 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
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|---|---|
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Change From Baseline in Liver Cu Concentration at Week 48 (Treatment Period)
|
92.8 μg/g
Standard Error 56.34
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (Treatment Period)Population: The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver Cu value evaluable. 'Number analyzed' signifies participants evaluable at specified timepoint.
Fibrosis from histology was evaluated by NASH CRN Fibrosis Stage, which was scaled from 0 to 4 stages where Score 0: None; Score 1: Perisinusoidal or periportal - 1a - mild, zone 3, perisinusoidal; Score 1: Perisinusoidal or periportal - 1b - moderate, zone 3, perisinusoidal; Score 1: Perisinusoidal or periportal - 1c - portal/periportal; Score 2: Both perisinusoidal and portal/periportal; Score 3: Bridging fibrosis; and Score 4: Cirrhosis. Higher scores indicated greater fibrosis.
Outcome measures
| Measure |
ALXN1840
n=29 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
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|---|---|
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Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Baseline · Score 0
|
7 Participants
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|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Baseline · Score 3
|
8 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Week 48 · Score 1c
|
6 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Baseline · Score 1a
|
1 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Baseline · Score 1b
|
0 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Baseline · Score 1c
|
7 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Baseline · Score 2
|
3 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Baseline · Score 4
|
2 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Baseline · Not evaluable
|
1 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Week 48 · Score 0
|
5 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Week 48 · Score 1a
|
0 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Week 48 · Score 1b
|
0 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Week 48 · Score 2
|
6 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Week 48 · Score 3
|
7 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Week 48 · Score 4
|
0 Participants
|
|
Number of Participants With Change From Baseline in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Stage at Week 48 (Treatment Period)
Week 48 · Not evaluable
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (Treatment Period)Population: The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver Cu value evaluable. 'Number analyzed' signifies participants evaluable at specified timepoint.
Fibrosis from histology was evaluated by Metavir Fibrosis Score, which was ranged from 0 to 4 where Score 0: No fibrosis; Score 1: Stellate enlargement of portal tract but without septa formation; Score 2: Enlargement of portal tract with rare septa formation; Score 3: Numerous septa without cirrhosis; and Score 4: Cirrhosis. Higher scores indicated greater fibrosis.
Outcome measures
| Measure |
ALXN1840
n=29 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
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|---|---|
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Number of Participants With Change From Baseline in Metavir Fibrosis Score at Week 48 (Treatment Period)
Baseline · Score 0
|
8 Participants
|
|
Number of Participants With Change From Baseline in Metavir Fibrosis Score at Week 48 (Treatment Period)
Baseline · Not evaluable
|
1 Participants
|
|
Number of Participants With Change From Baseline in Metavir Fibrosis Score at Week 48 (Treatment Period)
Baseline · Score 1
|
7 Participants
|
|
Number of Participants With Change From Baseline in Metavir Fibrosis Score at Week 48 (Treatment Period)
Baseline · Score 2
|
4 Participants
|
|
Number of Participants With Change From Baseline in Metavir Fibrosis Score at Week 48 (Treatment Period)
Baseline · Score 3
|
7 Participants
|
|
Number of Participants With Change From Baseline in Metavir Fibrosis Score at Week 48 (Treatment Period)
Baseline · Score 4
|
2 Participants
|
|
Number of Participants With Change From Baseline in Metavir Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Score 0
|
5 Participants
|
|
Number of Participants With Change From Baseline in Metavir Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Score 1
|
4 Participants
|
|
Number of Participants With Change From Baseline in Metavir Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Score 2
|
8 Participants
|
|
Number of Participants With Change From Baseline in Metavir Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Score 3
|
7 Participants
|
|
Number of Participants With Change From Baseline in Metavir Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Score 4
|
0 Participants
|
|
Number of Participants With Change From Baseline in Metavir Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Not evaluable
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (Treatment Period)Population: The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver Cu value evaluable. 'Number analyzed' signifies participants evaluable at specified timepoint.
Fibrosis from histology was evaluated by Ishak Fibrosis Score, which was ranged from 0 to 6 where Score 0: No fibrosis; Score 1: Fibrous expansion of some portal areas, with or without short fibrous septa; Score 2: Fibrous expansion of most portal areas, with or without short fibrous septa; Score 3: Fibrous expansion of most portal areas with occasional portal to portal (P-P) bridging; and Score 4: Fibrous expansion of portal areas with marked bridging (P-P) as well as portal central (P-C); Score 5: Marked bridging (P-P and/or P-C) with occasional nodules (incomplete cirrhosis); and Score 6: Cirrhosis, probable or definite. Higher scores indicated greater fibrosis.
Outcome measures
| Measure |
ALXN1840
n=29 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
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|---|---|
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Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Baseline · Score 0
|
8 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Baseline · Score 1
|
6 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Baseline · Score 2
|
2 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Baseline · Score 3
|
9 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Baseline · Score 4
|
1 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Baseline · Score 5
|
1 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Baseline · Score 6
|
1 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Baseline · Not evaluable
|
1 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Score 0
|
5 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Score 1
|
4 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Score 2
|
4 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Score 3
|
8 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Score 4
|
3 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Score 5
|
0 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Score 6
|
0 Participants
|
|
Number of Participants With Change From Baseline in Ishak Fibrosis Score at Week 48 (Treatment Period)
Week 48 · Not evaluable
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (Treatment Period)Population: The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver Cu value evaluable. 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Fibrosis from histology was evaluated by morphometric quantification of hepatic collagen content.
Outcome measures
| Measure |
ALXN1840
n=24 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
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|---|---|
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Change From Baseline in Hepatic Collagen Content at Week 48 (Treatment Period)
|
8.5445 percentage of collagen
Standard Deviation 15.54224
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (Treatment Period)Population: The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver Cu value evaluable. 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Fibrosis from histology was evaluated by morphometric quantification of hepatic a-SMA content.
Outcome measures
| Measure |
ALXN1840
n=24 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
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|---|---|
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Change From Baseline in a-SMA Content at Week 48 (Treatment Period)
|
1.6002 percentage of a-SMA
Standard Deviation 5.47274
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (Treatment Period)Population: The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver Cu value evaluable. 'Number analyzed' signifies participants evaluable at specified timepoint.
Steatosis from histology was evaluated by the steatosis component of the NAS, which was ranged from 0 to 3 where Score 0: \< 5% (minimal); Score 1: 5 - 33% (mild); Score 2: 34 - 66% (moderate); and Score 3: \> 66% (severe). Higher scores indicated greater steatosis.
Outcome measures
| Measure |
ALXN1840
n=29 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
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|---|---|
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Number of Participants With Change From Baseline in NAS Steatosis Grading Score at Week 48 (Treatment Period)
Baseline · Score 0
|
19 Participants
|
|
Number of Participants With Change From Baseline in NAS Steatosis Grading Score at Week 48 (Treatment Period)
Baseline · Score 1
|
6 Participants
|
|
Number of Participants With Change From Baseline in NAS Steatosis Grading Score at Week 48 (Treatment Period)
Baseline · Score 2
|
3 Participants
|
|
Number of Participants With Change From Baseline in NAS Steatosis Grading Score at Week 48 (Treatment Period)
Baseline · Score 3
|
1 Participants
|
|
Number of Participants With Change From Baseline in NAS Steatosis Grading Score at Week 48 (Treatment Period)
Week 48 · Score 0
|
15 Participants
|
|
Number of Participants With Change From Baseline in NAS Steatosis Grading Score at Week 48 (Treatment Period)
Week 48 · Score 1
|
6 Participants
|
|
Number of Participants With Change From Baseline in NAS Steatosis Grading Score at Week 48 (Treatment Period)
Week 48 · Score 2
|
2 Participants
|
|
Number of Participants With Change From Baseline in NAS Steatosis Grading Score at Week 48 (Treatment Period)
Week 48 · Score 3
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (Treatment Period)Population: The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver Cu value evaluable. 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Steatosis from histology was evaluated by morphometric quantification of hepatic fat content.
Outcome measures
| Measure |
ALXN1840
n=24 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
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|---|---|
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Change From Baseline in Hepatic Fat Content at Week 48 (Treatment Period)
|
-0.2504 percentage of fat
Standard Deviation 2.19263
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (Treatment Period)Population: The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver Cu value evaluable. 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Inflammation was quantified by the NAS total score. The score is defined as the unweighted sum of the scores for steatosis (0 \[minimal\] to 3 \[severe\]), lobular inflammation (0 \[none\] to 3 \[\>4 foci / 200x field\]), and hepatocellular ballooning (0 \[none\] to 2 \[many\]), thus ranging from 0 (no inflammation) to 8 (severe inflammation), with higher scores indicating more severe disease.
Outcome measures
| Measure |
ALXN1840
n=24 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
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|---|---|
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Change From Baseline in NAS Total Score at Week 48 (Treatment Period)
|
0.1 units on a scale
Standard Deviation 1.69
|
SECONDARY outcome
Timeframe: Day 1 (Treatment Period) up to Week 48 (Treatment Period)Population: Safety Analysis Set in the Treatment Period included all participants who received at least 1 dose of treatment in the Treatment Period.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. The TEAEs were AEs with onset on or after the first study drug dose. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
ALXN1840
n=31 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
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|---|---|
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Treatment Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
30 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Extension Period) up Week 52 (Extension Period)Population: Safety Analysis Set in the Extension Period included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. The TEAEs were AEs with onset on or after the first study drug dose. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Outcome measures
| Measure |
ALXN1840
n=25 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
|
|---|---|
|
Extension Period: Number of Participants With TEAEs
|
24 Participants
|
SECONDARY outcome
Timeframe: Predose up to 4 hours postdose at Week 6 (Day 43) and Week 36 (Day 253)Population: Pharmacokinetic (PK) Analysis Set in the Treatment Period included all participants who received at least 1 dose of treatment in the Treatment Period and had evaluable PK data for total Mo and/or plasma ultrafiltrate (PUF) Mo (as surrogate measure for ALXN1840 PK) in plasma in the Treatment Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Outcome measures
| Measure |
ALXN1840
n=29 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
|
|---|---|
|
Treatment Period: Predose Trough Plasma Total Mo Concentration
Week 6
|
174.39 nanograms (ng)/milliliter (mL)
Standard Deviation 113.824
|
|
Treatment Period: Predose Trough Plasma Total Mo Concentration
Week 36
|
131.19 nanograms (ng)/milliliter (mL)
Standard Deviation 103.359
|
SECONDARY outcome
Timeframe: Predose up to 4 hours postdose at Week 6 (Day 43) and Week 36 (Day 253)Population: PK Analysis Set in the Treatment Period included all participants who received at least 1 dose of treatment in the Treatment Period and had evaluable PK data for total Mo and/or PUF Mo (as surrogate measure for ALXN1840 PK) in plasma in the Treatment Period. 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
ALXN1840
n=28 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
|
|---|---|
|
Treatment Period: Predose Trough Plasma Total PUF Mo Concentration
Week 6
|
5.888 ng/mL
Standard Deviation 2.0176
|
|
Treatment Period: Predose Trough Plasma Total PUF Mo Concentration
Week 36
|
7.843 ng/mL
Standard Deviation 6.0564
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (Treatment Period)Population: The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver Cu value evaluable. 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
ALXN1840
n=24 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
|
|---|---|
|
Change From Baseline in Mo in Liver Biopsy Specimen at Week 48 (Treatment Period)
|
69.6976 μg/g
Standard Deviation 43.02655
|
SECONDARY outcome
Timeframe: Week 48 (Treatment Period)Population: The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver Cu value evaluable. 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The CGI-I is a 7-point scale clinician assessment where 1= very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; or 7 = very much worse. Higher scores indicated worsening of disease.
Outcome measures
| Measure |
ALXN1840
n=25 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
|
|---|---|
|
Clinical Global Impression-Improvement (CGI-I) Scale Score at Week 48 (Treatment Period)
|
3.1 units on a scale
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Baseline, Week 48 (Treatment Period)Population: The Full Analysis Set in the Treatment Period included all participants who received at least 1 dose of study drug in the Treatment Period and had at least a Baseline liver Cu value evaluable. 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.
The CGI-S is a 7-point scale clinician assessment. Participants were assessed on severity of illness at the time of rating/assessment as follows: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; or 7 = extremely ill. Higher scores indicated worsening of disease.
Outcome measures
| Measure |
ALXN1840
n=25 Participants
Participants received ALXN1840 orally in the 48-week Treatment Period. Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840. Participants who did not enter the Extension Period discontinued dosing at Week 48, and had a final study visit for safety follow-up at Week 52.
|
|---|---|
|
Change From Baseline in CGI-S Scale Score at Week 48 (Treatment Period)
|
-0.4 units on a scale
Standard Deviation 1.50
|
Adverse Events
Treatment Period: ALXN1840
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Extension Period: ALXN1840
Serious events: 2 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Period: ALXN1840
n=31 participants at risk
Participants received ALXN1840 orally in the 48-week Treatment Period.
|
Extension Period: ALXN1840
n=25 participants at risk
Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840.
|
|---|---|---|
|
Hepatobiliary disorders
Drug-induced liver injury
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Hepatic enzyme increased
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Renal and urinary disorders
Bence Jones proteinuria
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Renal and urinary disorders
Ureteric obstruction
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Reproductive system and breast disorders
Prostatitis
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
Other adverse events
| Measure |
Treatment Period: ALXN1840
n=31 participants at risk
Participants received ALXN1840 orally in the 48-week Treatment Period.
|
Extension Period: ALXN1840
n=25 participants at risk
Participants who completed the 48-week Treatment Period and agreed to enter a 48-week Extension Period, continued to receive ALXN1840.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Eye disorders
Chalazion
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Eye disorders
Vision blurred
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Eye disorders
Vitreous detachment
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Nausea
|
19.4%
6/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
24.0%
6/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
12.0%
3/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Constipation
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Oral pain
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Dry mouth
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Faeces discoloured
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Flatulence
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Toothache
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
General disorders
Pyrexia
|
16.1%
5/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
12.0%
3/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
General disorders
Fatigue
|
12.9%
4/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
General disorders
Asthenia
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
General disorders
Chills
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
General disorders
Feeling abnormal
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
General disorders
Generalised oedema
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
General disorders
Pain
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
General disorders
Temperature intolerance
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Immune system disorders
Seasonal allergy
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Immune system disorders
Immunisation reaction
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Nasopharyngitis
|
16.1%
5/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
32.0%
8/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
COVID-19
|
12.9%
4/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
40.0%
10/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Kidney infection
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Pneumonia
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
16.0%
4/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Urinary tract infection
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Bacterial vaginosis
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Conjunctivitis
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Dermatophytosis
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Folliculitis
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Furuncle
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Gingivitis
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Helicobacter infection
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Paronychia
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Post procedural sepsis
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Respiratory tract infection
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Respiratory tract infection viral
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Sinusitis
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Head injury
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Post procedural hypotension
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Post vaccination syndrome
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Alanine aminotransferase increased
|
25.8%
8/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
32.0%
8/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Gamma-glutamyltransferase increased
|
25.8%
8/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
28.0%
7/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Blood alkaline phosphatase increased
|
12.9%
4/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
16.0%
4/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Hepatic enzyme increased
|
12.9%
4/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Aspartate aminotransferase increased
|
9.7%
3/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Blood creatine phosphokinase increased
|
9.7%
3/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
16.0%
4/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Transaminases increased
|
9.7%
3/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Blood bilirubin increased
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Liver function test increased
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Alanine aminotransferase abnormal
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Blood albumin decreased
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Blood folate decreased
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Creatinine renal clearance decreased
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Creatinine renal clearance increased
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Protein urine present
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Prothrombin time prolonged
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Urobilinogen urine increased
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Weight decreased
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Weight increased
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
White blood cell count decreased
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
9.7%
3/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
12.0%
3/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
3/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
16.0%
4/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Nervous system disorders
Headache
|
22.6%
7/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
24.0%
6/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Nervous system disorders
Lethargy
|
9.7%
3/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Nervous system disorders
Dizziness
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Nervous system disorders
Presyncope
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Nervous system disorders
Tremor
|
6.5%
2/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Nervous system disorders
Balance disorder
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Nervous system disorders
Paraesthesia
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Psychiatric disorders
Anxiety
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Psychiatric disorders
Anxiety disorder
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Psychiatric disorders
Depressed mood
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Psychiatric disorders
Depression
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Psychiatric disorders
Insomnia
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Psychiatric disorders
Personality disorder
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Renal and urinary disorders
Glycosuria
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Renal and urinary disorders
Proteinuria
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Reproductive system and breast disorders
Breast mass
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Reproductive system and breast disorders
Breast tenderness
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
9.1%
1/11 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
11.1%
1/9 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
9.1%
1/11 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/9 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
9.1%
1/11 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
22.2%
2/9 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.7%
3/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Skin and subcutaneous tissue disorders
Idiopathic guttate hypomelanosis
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Vascular disorders
Deep vein thrombosis
|
3.2%
1/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
0.00%
0/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Eye disorders
Myopia
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
8.0%
2/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Nervous system disorders
Migraine
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Nervous system disorders
Serotonin syndrome
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
General disorders
Influenza like illness
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
General disorders
Swelling
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/31 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
4.0%
1/25 • Day 1 (Treatment Period) up to Week 52 (Extension Period) (up to a total of approximately 100 weeks)
All-cause mortality is reported for all enrolled participants in both periods. Serious and other adverse events are reported in the Safety Analysis Set in the Treatment Period, which included all participants who received at least 1 dose of treatment in the Treatment Period, and for the Safety Analysis Set in the Extension Period, which included all participants who received at least 1 dose of ALXN1840 in the Extension Period.
|
Additional Information
Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Phone: 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place