Trial Outcomes & Findings for An Efficacy and Safety Study of Ravulizumab in ALS Participants (NCT NCT04248465)
NCT ID: NCT04248465
Last Updated: 2023-01-10
Results Overview
The ALSFRS-Revised is a validated instrument for evaluating the levels of the functional status of participants with amyotrophic lateral sclerosis (ALS) in 4 areas, including bulbar, gross motor activity, fine motor activity, and respiratory functions. The scale included 12 functional items and each item is rated on a 0 to 4 scale, with a maximum total score of 48. A higher score indicated greater retention of function. Baseline was defined as last non-missing value on or before first study drug administration.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
382 participants
Primary outcome timeframe
Baseline, Week 50
Results posted on
2023-01-10
Participant Flow
Participant milestones
| Measure |
Ravulizumab/Ravulizumab
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then once every 8 weeks (q8w) up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded 900 milligrams (mg) dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Placebo/Ravulizumab
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
|---|---|---|
|
Randomized-Controlled Period
STARTED
|
255
|
127
|
|
Randomized-Controlled Period
Received at Least 1 Dose of Study Drug
|
255
|
127
|
|
Randomized-Controlled Period
COMPLETED
|
15
|
5
|
|
Randomized-Controlled Period
NOT COMPLETED
|
240
|
122
|
|
Open-label Extension Period
STARTED
|
14
|
5
|
|
Open-label Extension Period
Received at Least 1 Dose of Study Drug
|
14
|
5
|
|
Open-label Extension Period
COMPLETED
|
0
|
0
|
|
Open-label Extension Period
NOT COMPLETED
|
14
|
5
|
Reasons for withdrawal
| Measure |
Ravulizumab/Ravulizumab
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then once every 8 weeks (q8w) up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded 900 milligrams (mg) dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Placebo/Ravulizumab
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
|---|---|---|
|
Randomized-Controlled Period
Death
|
12
|
5
|
|
Randomized-Controlled Period
Adverse Event
|
2
|
0
|
|
Randomized-Controlled Period
Study Terminated by Sponsor
|
194
|
99
|
|
Randomized-Controlled Period
Withdrawal by Subject
|
30
|
17
|
|
Randomized-Controlled Period
Physician Decision
|
1
|
1
|
|
Randomized-Controlled Period
Lost to Follow-up
|
1
|
0
|
|
Open-label Extension Period
Study Terminated by Sponsor
|
14
|
4
|
|
Open-label Extension Period
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
An Efficacy and Safety Study of Ravulizumab in ALS Participants
Baseline characteristics by cohort
| Measure |
Ravulizumab
n=255 Participants
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then, during the Open Label Extension Period, participants received ravulizumab, with a blinded 900 mg dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Placebo
n=127 Participants
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Total
n=382 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 10.57 • n=99 Participants
|
58.0 years
STANDARD_DEVIATION 11.03 • n=107 Participants
|
58.4 years
STANDARD_DEVIATION 10.72 • n=206 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
152 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
230 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
205 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
310 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
202 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
305 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 50Population: FAS included all randomized participants who received at least 1 dose of study drug grouped by randomized treatment group. Here, Number of Participants analyzed signifies those participants who were evaluable for this outcome measure.
The ALSFRS-Revised is a validated instrument for evaluating the levels of the functional status of participants with amyotrophic lateral sclerosis (ALS) in 4 areas, including bulbar, gross motor activity, fine motor activity, and respiratory functions. The scale included 12 functional items and each item is rated on a 0 to 4 scale, with a maximum total score of 48. A higher score indicated greater retention of function. Baseline was defined as last non-missing value on or before first study drug administration.
Outcome measures
| Measure |
Ravulizumab
n=32 Participants
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then, during the Open Label Extension Period, participants received ravulizumab, with a blinded 900 mg dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Placebo
n=14 Participants
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
|---|---|---|
|
Change From Baseline In Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Total Score
|
-11.9 units on a scale
Standard Deviation 7.30
|
-10.6 units on a scale
Standard Deviation 6.05
|
SECONDARY outcome
Timeframe: Up to Week 50Population: FAS included all randomized participants who received at least 1 dose of study drug grouped by randomized treatment group.
Ventilation Assistance-Free Survival (VAFS) is a composite endpoint of survival and severe and irreversible respiratory decline. The use of VAFS allowed for the collection of survival data that was not impacted by survival prolongation from noninvasive or permanent ventilatory interventions which could prolong life without impacting underlying disease progression.
Outcome measures
| Measure |
Ravulizumab
n=255 Participants
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then, during the Open Label Extension Period, participants received ravulizumab, with a blinded 900 mg dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Placebo
n=127 Participants
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
|---|---|---|
|
Time To Ventilator Assistance-free Survival
|
6.05 months
Interval 0.79 to 11.1
|
7.69 months
Interval 4.83 to 9.53
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: FAS included all randomized participants who received at least 1 dose of study drug grouped by randomized treatment group. Here, Number of Participants analyzed signifies those participants who were evaluable for this outcome measure.
Slow vital capacity measures slow and gradual expulsion of air from the lungs using a spirometer.
Outcome measures
| Measure |
Ravulizumab
n=19 Participants
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then, during the Open Label Extension Period, participants received ravulizumab, with a blinded 900 mg dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Placebo
n=9 Participants
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
|---|---|---|
|
Change From Baseline In Percent Predicted Slow Vital Capacity
|
-20.9 percentage of predicted volume
Standard Deviation 19.74
|
-21.3 percentage of predicted volume
Standard Deviation 13.90
|
SECONDARY outcome
Timeframe: Baseline up to Week 156Population: Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data).
An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. 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 |
Ravulizumab
n=255 Participants
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then, during the Open Label Extension Period, participants received ravulizumab, with a blinded 900 mg dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Placebo
n=127 Participants
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events, and TEAEs Leading To Study Drug Discontinuation
TEAEs
|
204 Participants
|
108 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events, and TEAEs Leading To Study Drug Discontinuation
Treatment Emergent Serious AEs
|
41 Participants
|
24 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events, and TEAEs Leading To Study Drug Discontinuation
TEAE Leading to Study Drug Discontinuation
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: FAS included all randomized participants who received at least 1 dose of study drug grouped by randomized treatment group. Here, Number of Participants analyzed signifies those participants who were evaluable for this outcome measure.
Handheld dynamometry (HHD) is a procedure for quantitative strength testing. Muscle strength testing was performed on prespecified muscles in the upper and lower extremities bilaterally and the force measurements were recorded. Force of measurement is reported in megascores (lower, upper, total). The total megascore is defined as the average of the non-missing ratios over baseline for all the muscles involved. The megascore at baseline is always 100. The range of a potential megascore can not be determined in advance. A megascore \>100 indicates more strength compared to baseline.
Outcome measures
| Measure |
Ravulizumab
n=26 Participants
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then, during the Open Label Extension Period, participants received ravulizumab, with a blinded 900 mg dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Placebo
n=13 Participants
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
|---|---|---|
|
Change From Baseline In Muscle Strength As Assessed By Handheld Dynamometry
|
-46.5 % (as the unit of megascore)
Standard Deviation 27.57
|
-53.4 % (as the unit of megascore)
Standard Deviation 20.28
|
SECONDARY outcome
Timeframe: Baseline, Week 50Population: FAS included all randomized participants who received at least 1 dose of study drug grouped by randomized treatment group. Here, Number of Participants analyzed signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Ravulizumab
n=14 Participants
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then, during the Open Label Extension Period, participants received ravulizumab, with a blinded 900 mg dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Placebo
n=7 Participants
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
|---|---|---|
|
Change From Baseline In Serum Neurofilament Light Chain
|
91.5 picograms/milliliter
Standard Deviation 40.40
|
73.1 picograms/milliliter
Standard Deviation 27.82
|
SECONDARY outcome
Timeframe: Baseline, Predose at Week 50Population: Pharmacokinetic Analysis Set (PKAS) included all participants who received at least 1 dose of the study drug and had at least 1 postdose pharmacokinetic (PK) sample. This endpoint was planned to be reported for Ravulizumab arm only.
Outcome measures
| Measure |
Ravulizumab
n=14 Participants
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then, during the Open Label Extension Period, participants received ravulizumab, with a blinded 900 mg dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Placebo
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in Serum Ravulizumab Concentration Over the Study Duration
|
634 micrograms/milliliter
Geometric Coefficient of Variation 29.1
|
—
|
SECONDARY outcome
Timeframe: Baseline, Predose at Week 50Population: Pharmacodynamic analysis set (PDAS) included all participants who received at least 1 dose of the study drug and had at least 1 postdose pharmacodynamics (PD) sample. Here, Number of Participants analyzed signifies those participants who were evaluable for this outcome measure. There were no participants with evaluable C5 data in the Placebo arm at Week 50.
Outcome measures
| Measure |
Ravulizumab
n=13 Participants
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then, during the Open Label Extension Period, participants received ravulizumab, with a blinded 900 mg dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Placebo
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
|---|---|---|
|
Change From Baseline in Serum Free Complement Component 5 (C5) Concentration Over the Study Duration
|
-155.2 micrograms/milliliter
Standard Deviation 24.42
|
—
|
SECONDARY outcome
Timeframe: Week 50Population: PDAS included all participants who received at least 1 dose of the study drug and had at least 1 postdose PD sample. Here, Number of Participants analyzed signifies those participants who were evaluable at Week 50. There were no participants with evaluable C5 data in the Placebo arm at Week 50.
Blood samples were collected to evaluate antibody response through development of ADAs.
Outcome measures
| Measure |
Ravulizumab
n=23 Participants
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then, during the Open Label Extension Period, participants received ravulizumab, with a blinded 900 mg dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Placebo
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive) during the Randomized Controlled Period. Then during the Open Label Extension Period, participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
|---|---|---|
|
Number of Participants With Positive Antidrug Antibodies (ADAs) to ALXN1210
|
0 Participants
|
—
|
Adverse Events
Randomized Controlled Period: Ravulizumab
Serious events: 41 serious events
Other events: 196 other events
Deaths: 15 deaths
Randomized Controlled Period: Placebo
Serious events: 24 serious events
Other events: 106 other events
Deaths: 6 deaths
Open Label Extension Period: Ravulizumab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Open Label Extension Period: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Randomized Controlled Period: Ravulizumab
n=255 participants at risk
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive).
|
Randomized Controlled Period: Placebo
n=127 participants at risk
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive).
|
Open Label Extension Period: Ravulizumab
n=14 participants at risk
Participants received ravulizumab, with a blinded 900 mg dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Open Label Extension Period: Placebo
n=5 participants at risk
Participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Infections and infestations
Pneumonia
|
1.2%
3/255 • Number of events 3 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
3.9%
5/127 • Number of events 6 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Infections and infestations
Pneumonia aspiration
|
0.78%
2/255 • Number of events 2 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
1.6%
2/127 • Number of events 2 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Infections and infestations
Bronchitis
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Infections and infestations
Pneumonia bacterial
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Infections and infestations
Pyelonephritis
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Infections and infestations
Respiratory tract infection
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Infections and infestations
COVID-19
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
7.1%
1/14 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Injury, poisoning and procedural complications
Gastrostomy failure
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Gastrointestinal disorders
Dysphagia
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
1.6%
2/127 • Number of events 2 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
General disorders
Death
|
0.78%
2/255 • Number of events 2 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
General disorders
Complication associated with device
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
General disorders
Pyrexia
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Nervous system disorders
Headache
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Nervous system disorders
Syncope
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Psychiatric disorders
Completed suicide
|
0.78%
2/255 • Number of events 2 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Psychiatric disorders
Assisted suicide
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.1%
8/255 • Number of events 8 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
3.1%
4/127 • Number of events 4 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
3/255 • Number of events 3 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
1.6%
2/127 • Number of events 2 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Psychiatric disorders
Mental status changes
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis aspiration
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
3.1%
4/127 • Number of events 4 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Metabolism and nutrition disorders
Euglycaemic diabetic ketoacidosis
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Investigations
Myocardial necrosis marker increased
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Investigations
Weight decreased
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Social circumstances
Feeding tube user
|
0.39%
1/255 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Surgical and medical procedures
Euthanasia
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.79%
1/127 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
7.1%
1/14 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
Other adverse events
| Measure |
Randomized Controlled Period: Ravulizumab
n=255 participants at risk
Participants received a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive).
|
Randomized Controlled Period: Placebo
n=127 participants at risk
Participants received a weight-based loading dose of placebo matched to ravulizumab on Day 1, followed by a weight-based maintenance dose on Day 15, then q8w up to Week 42 (inclusive).
|
Open Label Extension Period: Ravulizumab
n=14 participants at risk
Participants received ravulizumab, with a blinded 900 mg dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
Open Label Extension Period: Placebo
n=5 participants at risk
Participants received ravulizumab, with a blinded loading dose at Week 50, followed by an open-label ravulizumab maintenance dose at Week 52, then q8w for up to 106 weeks of treatment.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
16.5%
42/255 • Number of events 62 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
17.3%
22/127 • Number of events 29 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
7.1%
1/14 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
General disorders
Fatigue
|
8.6%
22/255 • Number of events 40 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
8.7%
11/127 • Number of events 11 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
4/255 • Number of events 6 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
7.1%
9/127 • Number of events 10 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Injury, poisoning and procedural complications
Fall
|
21.2%
54/255 • Number of events 81 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
28.3%
36/127 • Number of events 65 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
7.1%
1/14 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
20.0%
1/5 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.3%
11/255 • Number of events 13 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
6.3%
8/127 • Number of events 13 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Gastrointestinal disorders
Constipation
|
10.2%
26/255 • Number of events 29 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
3.9%
5/127 • Number of events 5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Gastrointestinal disorders
Nausea
|
9.0%
23/255 • Number of events 28 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
7.9%
10/127 • Number of events 10 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
8.2%
21/255 • Number of events 31 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
3.9%
5/127 • Number of events 7 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
18/255 • Number of events 23 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
3.1%
4/127 • Number of events 5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Infections and infestations
Urinary tract infection
|
4.7%
12/255 • Number of events 12 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
8.7%
11/127 • Number of events 12 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Psychiatric disorders
Insomnia
|
5.1%
13/255 • Number of events 14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
6.3%
8/127 • Number of events 8 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
20.0%
1/5 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/14 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
20.0%
1/5 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
7.1%
1/14 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/255 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/127 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
7.1%
1/14 • Number of events 1 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
0.00%
0/5 • Baseline up to Week 156
Safety Set included all participants who received at least 1 dose of study drug grouped by treatment actually received (for reporting exposure and safety data). "All-Cause Mortality" reports all deaths that occurred during the study, including the deaths that led to Study Discontinuation.
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Phone: +1 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place