Trial Outcomes & Findings for Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS) (NCT NCT02949128)
NCT ID: NCT02949128
Last Updated: 2024-02-20
Results Overview
Complete TMA response during the 26-week Initial Evaluation Period is a composite outcome measure that required normalization of hematological parameters (platelet count and lactate dehydrogenase \[LDH\]) and improvement in kidney function (≥25% reduction in serum creatinine from baseline); for participants on dialysis, baseline was established at least 6 days after the end of dialysis. Participants had to meet these criteria for 2 separate assessments obtained at least 4 weeks (28 days) apart, and any measurement in between. To be considered a responder during the 26-week Initial Evaluation Period, the latest time point a participant could first meet the response criteria was 28 days before the Week 26 (Day 183) assessment. Formal statistical comparison analyses were not planned for this study. The percentage was based on the responders among treated participants. The 95% confidence interval (CI) was based on the asymptotic Gaussian approximation method with a continuity correction.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
58 participants
Primary outcome timeframe
Week 26
Results posted on
2024-02-20
Participant Flow
Participant milestones
| Measure |
Ravulizumab
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter. After the Initial Evaluation Period, participants entered an Extension Period and received ravulizumab until the product registration or approval (in accordance with country-specific regulations) or for up to 4.5 years, whichever occurs first.
|
|---|---|
|
Initial Evaluation Period (26 Weeks)
STARTED
|
58
|
|
Initial Evaluation Period (26 Weeks)
Received At Least 1 Dose of Study Drug
|
58
|
|
Initial Evaluation Period (26 Weeks)
COMPLETED
|
49
|
|
Initial Evaluation Period (26 Weeks)
NOT COMPLETED
|
9
|
|
Extension Period (Up to 4.5 Years)
STARTED
|
49
|
|
Extension Period (Up to 4.5 Years)
Received At Least 1 Dose of Study Drug
|
47
|
|
Extension Period (Up to 4.5 Years)
COMPLETED
|
28
|
|
Extension Period (Up to 4.5 Years)
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
Ravulizumab
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter. After the Initial Evaluation Period, participants entered an Extension Period and received ravulizumab until the product registration or approval (in accordance with country-specific regulations) or for up to 4.5 years, whichever occurs first.
|
|---|---|
|
Initial Evaluation Period (26 Weeks)
Failed to Meet Eligibility Criteria
|
2
|
|
Initial Evaluation Period (26 Weeks)
Adverse Event
|
3
|
|
Initial Evaluation Period (26 Weeks)
Death
|
2
|
|
Initial Evaluation Period (26 Weeks)
Physician Decision
|
1
|
|
Initial Evaluation Period (26 Weeks)
Protocol Violation
|
1
|
|
Extension Period (Up to 4.5 Years)
Death
|
1
|
|
Extension Period (Up to 4.5 Years)
Physician Decision
|
5
|
|
Extension Period (Up to 4.5 Years)
Protocol Violation
|
1
|
|
Extension Period (Up to 4.5 Years)
Withdrawal by Subject
|
9
|
|
Extension Period (Up to 4.5 Years)
Other than specified
|
5
|
Baseline Characteristics
Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Baseline characteristics by cohort
| Measure |
Ravulizumab
n=56 Participants
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter. After the Initial Evaluation Period, participants entered an Extension Period and received ravulizumab until the product registration or approval (in accordance with country-specific regulations) or for up to 4.5 years, whichever occurs first.
|
|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 14.98 • n=93 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, and met pre-specified eligibility criteria.
Complete TMA response during the 26-week Initial Evaluation Period is a composite outcome measure that required normalization of hematological parameters (platelet count and lactate dehydrogenase \[LDH\]) and improvement in kidney function (≥25% reduction in serum creatinine from baseline); for participants on dialysis, baseline was established at least 6 days after the end of dialysis. Participants had to meet these criteria for 2 separate assessments obtained at least 4 weeks (28 days) apart, and any measurement in between. To be considered a responder during the 26-week Initial Evaluation Period, the latest time point a participant could first meet the response criteria was 28 days before the Week 26 (Day 183) assessment. Formal statistical comparison analyses were not planned for this study. The percentage was based on the responders among treated participants. The 95% confidence interval (CI) was based on the asymptotic Gaussian approximation method with a continuity correction.
Outcome measures
| Measure |
Ravulizumab
n=56 Participants
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
|
|---|---|
|
Percentage Of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26
Complete TMA Response
|
53.6 percentage of participants
Interval 39.6 to 67.5
|
|
Percentage Of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26
Platelet count normalization
|
83.9 percentage of participants
Interval 73.4 to 94.4
|
|
Percentage Of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26
LDH normalization
|
76.8 percentage of participants
Interval 64.8 to 88.7
|
|
Percentage Of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26
≥ 25% improvement in serum creatinine from baseline
|
58.9 percentage of participants
Interval 45.2 to 72.7
|
SECONDARY outcome
Timeframe: Baseline through Week 114Population: Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, and met pre-specified eligibility criteria.
Participants that did not have a response were censored at the date of last visit or study discontinuation at the time when the analysis was performed. The time to complete TMA Response is reported in days. The time of the event of a confirmed complete TMA response was considered the first time point at which all the criteria for complete TMA response were met.
Outcome measures
| Measure |
Ravulizumab
n=56 Participants
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
|
|---|---|
|
Time To Complete TMA Response
|
86.0 days
Interval 42.0 to
Participants who did not have a response were censored at the date of last visit or study discontinuation.
|
SECONDARY outcome
Timeframe: Week 26 and Week 52Population: Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint. Here, Overall Number of Participants analyzed signifies those who were evaluable for this outcome measure.
For participants requiring dialysis within 5 days prior to ALXN1210 treatment initiation, the number of participants no longer requiring dialysis is reported
Outcome measures
| Measure |
Ravulizumab
n=24 Participants
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
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|---|---|
|
Participants Who Do Not Require Dialysis at Weeks 26 and 52
Week 26
|
16 Participants
|
|
Participants Who Do Not Require Dialysis at Weeks 26 and 52
Week 52
|
16 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at specified timepoint (Week 52).
The proportion of participants considered responders, along with a 2-sided 95% CI for the Week 52 time point, is reported. To be considered a responder during the 26-week Initial Evaluation Period, the latest time point a participant could first meet the response criteria was 28 days before the Week 26 (Day 183) assessment (components of the response maintained for at least 28 days).
Outcome measures
| Measure |
Ravulizumab
n=44 Participants
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
|
|---|---|
|
Proportion Of Participants With Complete TMA Response At Week 52
Complete TMA Response
|
0.500 proportion of participants
Interval 0.346 to 0.654
|
|
Proportion Of Participants With Complete TMA Response At Week 52
Platelet Count Normalization
|
0.909 proportion of participants
Interval 0.783 to 0.975
|
|
Proportion Of Participants With Complete TMA Response At Week 52
LDH Normalization
|
0.750 proportion of participants
Interval 0.597 to 0.868
|
|
Proportion Of Participants With Complete TMA Response At Week 52
≥25% improvement in serum creatinine from baseline
|
0.659 proportion of participants
Interval 0.501 to 0.795
|
SECONDARY outcome
Timeframe: Baseline, Week 26 and Week 52Population: Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at the specified timepoint (Week 26 or Week 52).
Kidney function evaluated by eGFR was summarized at baseline and the Week 26 and Week 52 time points using descriptive statistics for continuous variables for the observed value, as well as the change from baseline. The baseline value was defined as the average of the values from the assessments performed prior to the first study drug infusion (these could include results from Screening and the Day 1 visit). A value of 10 milliliters (mL)/minute (min)/1.73 meters squared (m\^2) for eGFR was imputed for participants requiring dialysis for acute kidney injury. The observed value and change from baseline are reported in mL/min/1.73 m\^2. An increase indicated improvement in kidney function.
Outcome measures
| Measure |
Ravulizumab
n=48 Participants
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
|
|---|---|
|
Change From Baseline In Estimated Glomerular Filtration Rate (eGFR) At Weeks 26 and 52
Baseline
|
10.00 mL/min/1.73 m^2
Interval 4.0 to 80.0
|
|
Change From Baseline In Estimated Glomerular Filtration Rate (eGFR) At Weeks 26 and 52
Change From Baseline at Week 26
|
29.00 mL/min/1.73 m^2
Interval -13.0 to 108.0
|
|
Change From Baseline In Estimated Glomerular Filtration Rate (eGFR) At Weeks 26 and 52
Change From Baseline at Week 52
|
23.00 mL/min/1.73 m^2
Interval -13.0 to 95.0
|
SECONDARY outcome
Timeframe: Baseline, Week 26, and Week 52Population: Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at the specified timepoint (Week 26 or Week 52). Here, Overall 'Number of Participants Analyzed' signifies those who were evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified categories.
The CKD stage is presented as the change from baseline in the participants that Improved (excluding those with Stage 1 \[normal renal function\] at baseline as they cannot improve), Worsened (excluding those with Stage 5 at baseline as they cannot worsen), and Stayed the Same, compared to the CKD stage at baseline. Baseline was derived based on the last available eGFR before starting treatment. Stage 5 was considered the worst category, while Stage 1 was considered the best category. A 2-sided 95% CI for the proportion, based on exact confidence limits using the Clopper-Pearson method, was provided for each category. The CKD stage was classified based on the National Kidney Foundation Chronic Kidney Disease Stage.
Outcome measures
| Measure |
Ravulizumab
n=47 Participants
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
|
|---|---|
|
Participants With Change From Baseline In CKD Stage At Weeks 26 and 52
Week 26, Worsened
|
2 Participants
|
|
Participants With Change From Baseline In CKD Stage At Weeks 26 and 52
Week 52, Stayed the Same
|
11 Participants
|
|
Participants With Change From Baseline In CKD Stage At Weeks 26 and 52
Week 26, Improved
|
32 Participants
|
|
Participants With Change From Baseline In CKD Stage At Weeks 26 and 52
Week 26, Stayed the Same
|
13 Participants
|
|
Participants With Change From Baseline In CKD Stage At Weeks 26 and 52
Week 52, Improved
|
30 Participants
|
|
Participants With Change From Baseline In CKD Stage At Weeks 26 and 52
Week 52, Worsened
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26 and Week 52Population: Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at the specified timepoints (Week 26 or 52).
The hematologic TMA parameter of platelet count was summarized at baseline and at Week 26 and Week 52 using descriptive statistics for continuous variables for the change from baseline. Results are reported in platelets\*10\^9/liter (L) blood.
Outcome measures
| Measure |
Ravulizumab
n=56 Participants
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
|
|---|---|
|
Change From Baseline In Platelet Count At Weeks 26 and 52
Baseline
|
95.25 platelets*10^9/L
Interval 18.0 to 473.0
|
|
Change From Baseline In Platelet Count At Weeks 26 and 52
Change From Baseline at Week 26
|
125.00 platelets*10^9/L
Interval -126.0 to 338.0
|
|
Change From Baseline In Platelet Count At Weeks 26 and 52
Change From Baseline at Week 52
|
126.25 platelets*10^9/L
Interval -51.5 to 335.0
|
SECONDARY outcome
Timeframe: Baseline, Week 26 and Week 52Population: Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at the specified timepoints (Week 26 or Week 52).
The hematologic TMA parameter of serum LDH was summarized at baseline and at Week 26 and Week 52 using descriptive statistics for continuous variables for the change from baseline. Results are reported in units (U)/L.
Outcome measures
| Measure |
Ravulizumab
n=56 Participants
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
|
|---|---|
|
Change From Baseline In LDH At Weeks 26 and 52
Baseline
|
508.00 U/L
Interval 229.5 to 3249.0
|
|
Change From Baseline In LDH At Weeks 26 and 52
Change From Baseline at Week 26
|
-310.75 U/L
Interval -3072.0 to 8.5
|
|
Change From Baseline In LDH At Weeks 26 and 52
Change From Baseline at Week 52
|
-293.75 U/L
Interval -3107.0 to 81.0
|
SECONDARY outcome
Timeframe: Baseline, Week 26 and Week 52Population: Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at the specified timepoints (Week 26 or Week 52).
The hematologic TMA parameter of hemoglobin level was summarized at baseline and at Week 26 and Week 52 using descriptive statistics for continuous variables for the change from baseline. Results are reported in grams (g)/L.
Outcome measures
| Measure |
Ravulizumab
n=56 Participants
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
|
|---|---|
|
Change From Baseline In Hemoglobin At Weeks 26 and 52
Baseline
|
85.00 g/L
Interval 60.5 to 140.0
|
|
Change From Baseline In Hemoglobin At Weeks 26 and 52
Change From Baseline at Week 26
|
35.00 g/L
Interval -9.0 to 69.0
|
|
Change From Baseline In Hemoglobin At Weeks 26 and 52
Change From Baseline at Week 52
|
41.75 g/L
Interval -25.0 to 83.5
|
SECONDARY outcome
Timeframe: Baseline through Week 26 and through Week 52Population: Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at the specified timepoints (Week 26 or Week 52). Here, Overall Number of Participants analyzed signifies those who were evaluable for this outcome measure.
The percentage of participants with an increase from baseline in hemoglobin ≥20 g/L, observed at 2 separate assessments obtained at least 4 weeks (28 days) apart, and any measurement in between, was assessed through Week 26 and Week 52 and is presented as the percentage of responders, along with a 2-sided 95% CI. The 95% CIs are based on exact confidence limits using the Clopper-Pearson method. To be considered a responder during the 26-week and 52-week Extension Periods, the latest time point a participant could first meet the response criteria was 28 days before the respective Week 26 and Week 52 assessments (components of the response maintained for at least 28 days).
Outcome measures
| Measure |
Ravulizumab
n=38 Participants
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
|
|---|---|
|
Percentage Of Complement Inhibitor Treatment-naïve Participants With An Increase From Baseline In Hemoglobin ≥20 g/L Through Week 26 and Week 52
Week 26
|
75.5 percentage of participants
Interval 61.1 to 86.7
|
|
Percentage Of Complement Inhibitor Treatment-naïve Participants With An Increase From Baseline In Hemoglobin ≥20 g/L Through Week 26 and Week 52
Week 52
|
86.4 percentage of participants
Interval 72.6 to 94.8
|
SECONDARY outcome
Timeframe: Baseline, Week 26 and Week 52Population: Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at the specified timepoint (Week 26 or Week 52).
The EQ-5D-3L is a participant-answered questionnaire that scores 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (scored as a 1, 2, or 3, with 3 being the worst health state), as well as health state on a visual analogue scale (0 to 100, with 100 representing the best health state). From these scores, a summary index score is derived using the time trade-off valuation set for the United States and ranges from -1 to 1, where a score above 0.94 indicates full health. An increase in score from baseline indicates improvement in quality of life.
Outcome measures
| Measure |
Ravulizumab
n=53 Participants
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
|
|---|---|
|
Change From Baseline In Quality Of Life As Measured By The EuroQol 5-Dimension 3-Level (EQ-5D-3L) At Weeks 26 and 52
Baseline
|
0.59 units on a scale
Interval -0.113 to 0.753
|
|
Change From Baseline In Quality Of Life As Measured By The EuroQol 5-Dimension 3-Level (EQ-5D-3L) At Weeks 26 and 52
Change from Baseline at Week 26
|
0.15 units on a scale
Interval -0.138 to 0.723
|
|
Change From Baseline In Quality Of Life As Measured By The EuroQol 5-Dimension 3-Level (EQ-5D-3L) At Weeks 26 and 52
Change from Baseline at Week 52
|
0.26 units on a scale
Interval -0.143 to 0.707
|
SECONDARY outcome
Timeframe: Baseline, Week 26 and Week 52Population: Full Analysis Set (FAS): all participants who received at least 1 dose of ravulizumab, had at least 1 post-baseline efficacy assessment, met pre-specified eligibility criteria, and had evaluable data at the specified timepoints (Week 26 and Week 52).
Quality of life was evaluated in part using FACIT Fatigue Version 4. The data were summarized at baseline and at the Week 26 and Week 52 time point using descriptive statistics for continuous variables. The FACIT Fatigue Version 4 questionnaire at baseline and the Week 52 timepoint was scored using standard scoring algorithms. The score ranges from 0-52, with a higher score indicating less Fatigue. An increase in score indicated an improvement in quality of life.
Outcome measures
| Measure |
Ravulizumab
n=48 Participants
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter.
|
|---|---|
|
Change From Baseline In Quality Of Life As Measured By The Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Version 4 Questionnaire At Weeks 26 and 52
Baseline
|
24.00 units on a scale
Interval 0.0 to 51.0
|
|
Change From Baseline In Quality Of Life As Measured By The Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Version 4 Questionnaire At Weeks 26 and 52
Change From Baseline at Week 26
|
20.00 units on a scale
Interval -16.0 to 48.0
|
|
Change From Baseline In Quality Of Life As Measured By The Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Version 4 Questionnaire At Weeks 26 and 52
Change From Baseline at Week 52
|
16.50 units on a scale
Interval -17.0 to 50.0
|
Adverse Events
Ravulizumab
Serious events: 38 serious events
Other events: 56 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Ravulizumab
n=58 participants at risk
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter. After the Initial Evaluation Period, participants entered an Extension Period and received ravulizumab until the product registration or approval (in accordance with country-specific regulations) or for up to 4.5 years, whichever occurs first.
|
|---|---|
|
Infections and infestations
Pneumonia
|
8.6%
5/58 • Number of events 6 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Septic shock
|
3.4%
2/58 • Number of events 2 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Urinary tract infection
|
3.4%
2/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Device related infection
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Escherichia pyelonephritis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Fungaemia
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Gastrointestinal infection
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Peritonitis bacterial
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Pharyngitis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Sepsis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Sinusitis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
2/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.7%
1/58 • Number of events 2 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
Hydronephrosis
|
3.4%
2/58 • Number of events 2 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
Renal failure
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
Renal haematoma
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
Renal impairment
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
Renal pseudoaneurysm
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Blood and lymphatic system disorders
Atypical haemolytic uraemic syndrome
|
3.4%
2/58 • Number of events 2 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Vascular disorders
Hypertension
|
5.2%
3/58 • Number of events 6 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Vascular disorders
Malignant hypertension
|
3.4%
2/58 • Number of events 7 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Vascular disorders
Hypertensive crisis
|
3.4%
2/58 • Number of events 2 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/58 • Number of events 2 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
3.4%
2/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Toothache
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Nervous system disorders
Lacunar infarction
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Nervous system disorders
Loss of consciousness
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Nervous system disorders
Seizure
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
3.4%
2/58 • Number of events 2 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
1.7%
1/58 • Number of events 2 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Immune system disorders
Hypersensitivity
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Immune system disorders
Kidney transplant rejection
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Injury, poisoning and procedural complications
Seroma
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
3.4%
2/58 • Number of events 2 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Investigations
Biopsy kidney
|
3.4%
2/58 • Number of events 2 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Investigations
Troponin increased
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Ear and labyrinth disorders
Vertigo positional
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Eye disorders
Vitreous haemorrhage
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Product Issues
Device leakage
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
General disorders
Systemic inflammatory response syndrome
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Surgical and medical procedures
Nephrectomy
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Vascular disorders
Arteriovenous fistula
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
End stage renal disease
|
5.2%
3/58 • Number of events 5 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Enterocolitis infectious
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Gastroenteritis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Influenza
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Peritonitis
|
1.7%
1/58 • Number of events 2 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Respiratory tract infection
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Stenotrophomonas infection
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
COVID-19
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Cellulitis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Endophthalmitis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Enterococcal infection
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Gastroenteritis viral
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Hantaviral infection
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Large intestine infection
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Pseudomonal sepsis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Pyelonephritis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Rhinovirus infection
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Staphylococcal sepsis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
1.7%
1/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
3.4%
2/58 • Number of events 2 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Injury, poisoning and procedural complications
Vascular access site thrombosis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Immune system disorders
Milk allergy
|
1.7%
1/58 • Number of events 2 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Immune system disorders
Transplant rejection
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Nervous system disorders
Cervicobrachial syndrome
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Cardiac disorders
Cardiac failure acute
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Cardiac disorders
Pericardial effusion
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Eye disorders
Vitreous disorder
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
Dysuria
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
1.7%
1/58 • Number of events 1 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
Other adverse events
| Measure |
Ravulizumab
n=58 participants at risk
Participants received weight-based dosages of ravulizumab for 26 weeks during the Initial Evaluation Period. Participants received a loading dose of ravulizumab intravenously on Day 1, followed by maintenance dosing on Day 15 and once every 8 weeks thereafter. After the Initial Evaluation Period, participants entered an Extension Period and received ravulizumab until the product registration or approval (in accordance with country-specific regulations) or for up to 4.5 years, whichever occurs first.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
36.2%
21/58 • Number of events 32 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Vomiting
|
29.3%
17/58 • Number of events 22 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Nausea
|
29.3%
17/58 • Number of events 27 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Constipation
|
17.2%
10/58 • Number of events 13 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
10.3%
6/58 • Number of events 9 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
10.3%
6/58 • Number of events 7 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Nervous system disorders
Headache
|
43.1%
25/58 • Number of events 41 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Nervous system disorders
Dizziness
|
12.1%
7/58 • Number of events 7 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Nervous system disorders
Somnolence
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Urinary tract infection
|
20.7%
12/58 • Number of events 25 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Nasopharyngitis
|
15.5%
9/58 • Number of events 29 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Oral herpes
|
6.9%
4/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
General disorders
Pyrexia
|
22.4%
13/58 • Number of events 14 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
General disorders
Oedema peripheral
|
19.0%
11/58 • Number of events 20 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
General disorders
Fatigue
|
15.5%
9/58 • Number of events 10 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
General disorders
Pain
|
8.6%
5/58 • Number of events 6 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
General disorders
Asthenia
|
12.1%
7/58 • Number of events 8 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
General disorders
Face oedema
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.7%
12/58 • Number of events 13 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.0%
11/58 • Number of events 17 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.9%
4/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.1%
7/58 • Number of events 16 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
5.2%
3/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.9%
4/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.3%
6/58 • Number of events 6 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.3%
6/58 • Number of events 6 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.1%
7/58 • Number of events 7 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.1%
7/58 • Number of events 8 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
27.6%
16/58 • Number of events 22 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.1%
7/58 • Number of events 7 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.3%
6/58 • Number of events 6 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.1%
7/58 • Number of events 10 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Vascular disorders
Hypertension
|
22.4%
13/58 • Number of events 21 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Vascular disorders
Hypotension
|
10.3%
6/58 • Number of events 7 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Injury, poisoning and procedural complications
Contusion
|
5.2%
3/58 • Number of events 5 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Investigations
Alanine aminotransferase increased
|
8.6%
5/58 • Number of events 8 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
6.9%
4/58 • Number of events 5 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
17.2%
10/58 • Number of events 10 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
End stage renal disease
|
6.9%
4/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
Haematuria
|
6.9%
4/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Psychiatric disorders
Anxiety
|
13.8%
8/58 • Number of events 13 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Psychiatric disorders
Insomnia
|
8.6%
5/58 • Number of events 5 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Eye disorders
Vision blurred
|
6.9%
4/58 • Number of events 5 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Cardiac disorders
Palpitations
|
6.9%
4/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Immune system disorders
Drug hypersensitivity
|
8.6%
5/58 • Number of events 7 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.1%
7/58 • Number of events 8 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Gastritis
|
5.2%
3/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Nervous system disorders
Hypoaesthesia
|
6.9%
4/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Device related infection
|
6.9%
4/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Gastroenteritis
|
6.9%
4/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Rhinitis
|
6.9%
4/58 • Number of events 5 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
6/58 • Number of events 6 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
General disorders
Catheter site pain
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Psychiatric disorders
Depression
|
6.9%
4/58 • Number of events 5 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Bronchitis
|
8.6%
5/58 • Number of events 5 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Sinusitis
|
8.6%
5/58 • Number of events 7 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Pneumonia
|
6.9%
4/58 • Number of events 7 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Influenza
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Nervous system disorders
Paraesthesia
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Nervous system disorders
Presyncope
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Metabolism and nutrition disorders
Iron deficiency
|
6.9%
4/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Injury, poisoning and procedural complications
Fall
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
5.2%
3/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Investigations
Blood creatinine increased
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Investigations
Weight decreased
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
5.2%
3/58 • Number of events 4 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Renal and urinary disorders
Dysuria
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Psychiatric disorders
Delirium
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Reproductive system and breast disorders
Ovarian cyst
|
5.2%
3/58 • Number of events 3 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
|
Infections and infestations
Cystitis
|
5.2%
3/58 • Number of events 6 • From the beginning of the initial evaluation period (Day1) up to 4.5 years
|
Additional Information
Alexion Pharmaceuticals Inc.
Alexion Pharmaceuticals Inc.
Phone: 855-752-2356
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place