Trial Outcomes & Findings for Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy (NCT NCT04170023)
NCT ID: NCT04170023
Last Updated: 2024-11-20
Results Overview
Hgb baseline was defined as the lowest Hgb value observed between and including screening and first dose date. To address the impact of transfusion, Hgb values collected within 4 weeks after transfusion were not included in the primary efficacy analysis. Change from Baseline = Hgb at Week 12 - Baseline Hgb.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2024-11-20
Participant Flow
The study included a 12-week Treatment Period and a 148-week or 200-week (for sites in New Zealand) Long-term Extension (LTE) Period.
Participant milestones
| Measure |
Group 1: Treatment Naive
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
Group 2: Eculizumab Switch
Participants who had received component 5 (C5) inhibition with eculizumab for at least 6 months, who continued to experience anemia (hemoglobin \[Hgb\] \<10 grams/deciliter \[dL\]) and reticulocytes above the upper limit of normal (ULN), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
Group 3: Danicopan Rollover
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
|---|---|---|---|
|
Treatment Period
STARTED
|
12
|
11
|
6
|
|
Treatment Period
Received at Least 1 Dose of Study Drug
|
12
|
11
|
6
|
|
Treatment Period
COMPLETED
|
12
|
11
|
6
|
|
Treatment Period
NOT COMPLETED
|
0
|
0
|
0
|
|
LTE Period
STARTED
|
12
|
11
|
6
|
|
LTE Period
Received at Least 1 Dose of Study Drug
|
12
|
11
|
6
|
|
LTE Period
COMPLETED
|
0
|
0
|
1
|
|
LTE Period
NOT COMPLETED
|
12
|
11
|
5
|
Reasons for withdrawal
| Measure |
Group 1: Treatment Naive
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
Group 2: Eculizumab Switch
Participants who had received component 5 (C5) inhibition with eculizumab for at least 6 months, who continued to experience anemia (hemoglobin \[Hgb\] \<10 grams/deciliter \[dL\]) and reticulocytes above the upper limit of normal (ULN), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
Group 3: Danicopan Rollover
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
|---|---|---|---|
|
LTE Period
Withdrawal by Subject
|
1
|
0
|
0
|
|
LTE Period
Study Termination
|
11
|
11
|
5
|
Baseline Characteristics
Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy
Baseline characteristics by cohort
| Measure |
Group 1: Treatment Naive
n=12 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
Group 2: Eculizumab Switch
n=11 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
Group 3: Danicopan Rollover
n=6 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.75 years
STANDARD_DEVIATION 17.099 • n=5 Participants
|
42.45 years
STANDARD_DEVIATION 13.419 • n=7 Participants
|
40.50 years
STANDARD_DEVIATION 16.718 • n=5 Participants
|
42.59 years
STANDARD_DEVIATION 15.186 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
HgB
|
81.17 grams/liter
STANDARD_DEVIATION 11.731 • n=5 Participants
|
91.00 grams/liter
STANDARD_DEVIATION 9.602 • n=7 Participants
|
130.67 grams/liter
STANDARD_DEVIATION 19.180 • n=5 Participants
|
95.14 grams/liter
STANDARD_DEVIATION 22.662 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Hgb baseline was defined as the lowest Hgb value observed between and including screening and first dose date. To address the impact of transfusion, Hgb values collected within 4 weeks after transfusion were not included in the primary efficacy analysis. Change from Baseline = Hgb at Week 12 - Baseline Hgb.
Outcome measures
| Measure |
Group 1: Treatment Naive
n=11 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=10 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=6 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Change From Baseline in Hgb at Week 12
|
35.6 grams/liter
Standard Deviation 14.70
|
32.5 grams/liter
Standard Deviation 20.03
|
-3.7 grams/liter
Standard Deviation 15.77
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study.
Transfusion avoidance: participants remained transfusion-free and did not require a transfusion during the period of interest.
Outcome measures
| Measure |
Group 1: Treatment Naive
n=12 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=11 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=6 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Number of Participants Who Had Transfusion Avoidance During 12 Weeks of Treatment With ALXN2050
|
9 Participants
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study.
Outcome measures
| Measure |
Group 1: Treatment Naive
n=12 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=11 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=6 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Number of Red Blood Cell (RBC) Units Transfused During 12 Weeks of Treatment
|
0.6 RBC units
Standard Deviation 1.24
|
0.1 RBC units
Standard Deviation 0.30
|
0.8 RBC units
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study.
Outcome measures
| Measure |
Group 1: Treatment Naive
n=12 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=11 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=6 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Number of Transfusion Instances During 12 Weeks of Treatment
|
0.4 transfusion instances
Standard Deviation 0.90
|
0.1 transfusion instances
Standard Deviation 0.30
|
0.5 transfusion instances
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Change from Baseline = Serum LDH levels at Week 12 - Baseline Serum LDH levels.
Outcome measures
| Measure |
Group 1: Treatment Naive
n=11 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=11 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=6 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Change From Baseline in Lactate Dehydrogenase (LDH) at Week 12
|
-1310.8 units/liter
Standard Deviation 424.89
|
160.2 units/liter
Standard Deviation 279.57
|
88.7 units/liter
Standard Deviation 265.00
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Change from Baseline = absolute reticulocyte count at Week 12 - Baseline reticulocyte count.
Outcome measures
| Measure |
Group 1: Treatment Naive
n=12 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=10 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=5 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Change From Baseline in Absolute Reticulocyte Count at Week 12
|
-100.6 10^3 cells/microliter (μL)
Standard Deviation 72.18
|
-179.0 10^3 cells/microliter (μL)
Standard Deviation 117.30
|
-24.0 10^3 cells/microliter (μL)
Standard Deviation 22.10
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for the specified category.
Outcome measures
| Measure |
Group 1: Treatment Naive
n=11 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=11 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=6 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Change From Baseline in Direct and Total Bilirubin at Week 12
Direct Bilirubin
|
-2.1 micromoles (μmol)/liter
Standard Deviation 2.10
|
-6.3 micromoles (μmol)/liter
Standard Deviation 5.16
|
0.4 micromoles (μmol)/liter
Standard Deviation 0.89
|
|
Change From Baseline in Direct and Total Bilirubin at Week 12
Total Bilirubin
|
-12.9 micromoles (μmol)/liter
Standard Deviation 10.07
|
-23.3 micromoles (μmol)/liter
Standard Deviation 24.89
|
1.5 micromoles (μmol)/liter
Standard Deviation 2.81
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
The PNH RBC clone size refers to the percentage of PNH-affected cells versus normal cells within the total cell population. Change from Baseline = PNH clone size at Week 12 - Baseline PNH clone size.
Outcome measures
| Measure |
Group 1: Treatment Naive
n=9 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=3 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=2 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Change From Baseline in Paroxysmal Nocturnal Hemoglobinuria (PNH) Red Blood Cell (RBC) Clone Size at Week 12
|
41.9 percentage of the total cell population
Standard Deviation 13.68
|
27.5 percentage of the total cell population
Standard Deviation 21.60
|
-12.0 percentage of the total cell population
Standard Deviation 26.94
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
C3 fragment deposition on PNH RBC was used as a marker of intra and extravascular hemolysis. Data are presented for the change from baseline to Week 12 in percentage of PNH RBCs with C3 fragment deposition.
Outcome measures
| Measure |
Group 1: Treatment Naive
n=10 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=3 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=2 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Change From Baseline in Component 3 (C3) Fragment Deposition on PNH RBCs at Week 12
|
0.0 percentage of PNH RBC
Standard Deviation 0.00
|
-388.6 percentage of PNH RBC
Standard Deviation 590.08
|
0.3 percentage of PNH RBC
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: From first dose of study drug up to Week 217Population: Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
An adverse event (AE) was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An SAE was an AE that met at least 1 of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization for the AE, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), or an important medical event or reaction. A TEAE was defined as an AE that emerged during treatment, had been absent prior to treatment, or worsened relative to the pretreatment state. 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 |
Group 1: Treatment Naive
n=12 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=11 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=6 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Events Leading to Discontinuation of Study Medication
Any AEs
|
12 Participants
|
10 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Events Leading to Discontinuation of Study Medication
SAEs
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Events Leading to Discontinuation of Study Medication
AEs Leading to Discontinuation of Study Medication
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, EOT visit (Maximum exposure: 213.4 weeks)Population: Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Hgb baseline was defined as the lowest Hgb value observed between and including screening and first dose date. Change from Baseline = Hgb at the EOT visit - Baseline Hgb.
Outcome measures
| Measure |
Group 1: Treatment Naive
n=10 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=8 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=5 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Change From Baseline in Hgb at the End of Treatment (EOT) During the LTE Period
|
44.9 grams/liter
Standard Deviation 21.07
|
32.5 grams/liter
Standard Deviation 7.17
|
2.4 grams/liter
Standard Deviation 19.44
|
SECONDARY outcome
Timeframe: Baseline, EOT visit (Maximum exposure: 213.4 weeks)Population: Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Change from Baseline = Serum LDH levels at the EOT visit - Baseline Serum LDH levels.
Outcome measures
| Measure |
Group 1: Treatment Naive
n=11 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=10 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=5 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Change From Baseline in LDH at the EOT During the LTE Period
|
-1084.1 units/liter
Standard Deviation 738.26
|
95.7 units/liter
Standard Deviation 223.88
|
-61.4 units/liter
Standard Deviation 62.85
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
The FACIT-Fatigue scale is a collection of quality-of-life questionnaires pertaining to the management of fatigue symptoms due to chronic illness. The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the preceding 7 days. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). Total scores ranged from 0 to 52, with higher score indicating better quality of life.
Outcome measures
| Measure |
Group 1: Treatment Naive
n=11 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=7 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=6 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale (Version 4) Total Score at Week 12
|
11.2 units on a scale
Standard Deviation 13.20
|
5.1 units on a scale
Standard Deviation 8.47
|
0.2 units on a scale
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: Baseline, EOT visit (Maximum exposure: 213.4 weeks)Population: Full analysis set included all participants who received at least 1 dose of ALXN2050 in this study. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
The FACIT-Fatigue scale is a collection of quality-of-life questionnaires pertaining to the management of fatigue symptoms due to chronic illness. The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the preceding 7 days. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). Total scores ranged from 0 to 52, with higher score indicating better quality of life.
Outcome measures
| Measure |
Group 1: Treatment Naive
n=11 Participants
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 2: Eculizumab Switch
n=9 Participants
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
Group 3: Danicopan Rollover
n=5 Participants
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period.
|
|---|---|---|---|
|
Change From Baseline in FACIT-Fatigue Scale (Version 4) Total Score at the EOT During the LTE Period
|
12.6 units on a scale
Standard Deviation 12.51
|
4.4 units on a scale
Standard Deviation 7.26
|
-3.4 units on a scale
Standard Deviation 10.26
|
Adverse Events
Group 1: Treatment Naive
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 2: Eculizumab Switch
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 3: Danicopan Rollover
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Treatment Naive
n=12 participants at risk
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
Group 2: Eculizumab Switch
n=11 participants at risk
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
Group 3: Danicopan Rollover
n=6 participants at risk
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Breakthrough haemolysis
|
33.3%
4/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Renal and urinary disorders
Acute kidney injury
|
25.0%
3/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
3/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Renal and urinary disorders
Haemoglobinuria
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Blood and lymphatic system disorders
Haemolysis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Hepatic enzyme increased
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Blood and lymphatic system disorders
Intravascular haemolysis
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Meningitis aseptic
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Urinary tract infection bacterial
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
Other adverse events
| Measure |
Group 1: Treatment Naive
n=12 participants at risk
Participants who were treatment-naive received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
Group 2: Eculizumab Switch
n=11 participants at risk
Participants who had received C5 inhibition with eculizumab for at least 6 months, who continued to experience anemia (Hgb \<10 grams/dL) and reticulocytes above the ULN, switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
Group 3: Danicopan Rollover
n=6 participants at risk
Participants who had received danicopan monotherapy during Study ACH471-103 (NCT03181633), switched to ALXN2050 in this study and received ALXN2050 orally for 12 weeks during the treatment period. At the end of Week 12, participants entered the 148-week LTE Period and continued to receive ALXN2050 orally.
|
|---|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Rhinitis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
2/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
27.3%
3/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Blood creatine increased
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
27.3%
3/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Liver function test increased
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
36.4%
4/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
33.3%
2/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Nervous system disorders
Headache
|
50.0%
6/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
27.3%
3/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Nervous system disorders
Migraine
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Renal and urinary disorders
Chromaturia
|
16.7%
2/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
33.3%
2/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Renal and urinary disorders
Haematuria
|
25.0%
3/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
36.4%
4/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
33.3%
2/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Renal and urinary disorders
Haemoglobinuria
|
25.0%
3/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
33.3%
2/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Blood and lymphatic system disorders
Intravascular haemolysis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Otitis media
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Blood and lymphatic system disorders
Breakthrough haemolysis
|
25.0%
3/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
36.4%
4/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Eye disorders
Episcleritis
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
2/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
2/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
3/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Enteritis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Stomatitis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Tongue geographic
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
4/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Catheter site rash
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Chest pain
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Chills
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Fatigue
|
50.0%
6/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
50.0%
3/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Influenza like illness
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
33.3%
2/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Vaccination site pain
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Eye disorders
Cataract
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Eye disorders
Exudative retinopathy
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Eye disorders
Retinal degeneration
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Eye disorders
Vitreous floaters
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Chronic gastritis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Gastritis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
25.0%
3/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Hiatus hernia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Large intestine polyp
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Asthenia
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Chest discomfort
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
General physical health deterioration
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Hyperthermia
|
16.7%
2/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Malaise
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Oedema
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Oedema peripheral
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Pain
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Pyrexia
|
16.7%
2/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
33.3%
2/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
General disorders
Rebound effect
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
COVID-19
|
33.3%
4/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
50.0%
3/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Cystitis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Ear infection
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Furuncle
|
16.7%
2/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Gastroenteritis
|
16.7%
2/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Influenza
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Lower respiratory tract infection
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Onychomycosis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Pyelonephritis acute
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Skin infection
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Tinea pedis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Tinea versicolour
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
6/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
33.3%
2/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Injury, poisoning and procedural complications
Immunisation reaction
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Cardiac murmur
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Epstein-Barr virus antibody positive
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Free haemoglobin present
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Hepatic enzyme increased
|
16.7%
2/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Low density lipoprotein increased
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Troponin increased
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Weight decreased
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Investigations
Weight increased
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Metabolism and nutrition disorders
Hypophagia
|
16.7%
2/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
41.7%
5/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
36.4%
4/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
3/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Nervous system disorders
Disturbance in attention
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
33.3%
2/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Nervous system disorders
Restless legs syndrome
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
18.2%
2/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Psychiatric disorders
Insomnia
|
25.0%
3/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Psychiatric disorders
Sleep disorder
|
16.7%
2/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Renal and urinary disorders
Choluria
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Reproductive system and breast disorders
Nipple pain
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract irritation
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
9.1%
1/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
16.7%
1/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Vascular disorders
Flushing
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/11 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
0.00%
0/6 • From first dose of study drug up to Week 217
Safety set included all participants who received at least 1 dose of ALXN2050 in this study.
|
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