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An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04201262
Recruitment Status : Active, not recruiting
First Posted : December 17, 2019
Results First Posted : August 9, 2023
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Intervention Biological: Ravulizumab
Enrollment 58
Recruitment Details This study utilized the placebo group from Study ECU-NMO-301 (NCT01892345) as an external placebo control.
Pre-assignment Details This study includes primary treatment period and long-term extension period. The study is ongoing, and the data reported here are for 'primary treatment period'. The duration of the primary treatment period was up to 2.25 years. The long-term extension period data will be reported after the completion of study.
Arm/Group Title Ravulizumab Placebo (ECU-NMO-301)
Hide Arm/Group Description Participants received a weight-based loading dose of ravulizumab via intravenous (IV) infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). Participants who received eculizumab matching placebo in study ECU-NMO-301.
Period Title: Overall Study
Started 58 47
Received at Least 1 Dose of Study Drug 58 47
Completed 0 44
Not Completed 58 3
Reason Not Completed
Adverse Event             1             2
Continuing in the study             57             0
Withdrawal by Subject             0             1
Arm/Group Title Ravulizumab Placebo (ECU-NMO-301) Total
Hide Arm/Group Description Participants received a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). Participants who received eculizumab matching placebo in study ECU-NMO-301. Total of all reporting groups
Overall Number of Baseline Participants 58 47 105
Hide Baseline Analysis Population Description
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 47 participants 105 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
  87.9%
44
  93.6%
95
  90.5%
>=65 years
7
  12.1%
3
   6.4%
10
   9.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 47 participants 105 participants
Female
52
  89.7%
42
  89.4%
94
  89.5%
Male
6
  10.3%
5
  10.6%
11
  10.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 47 participants 105 participants
Hispanic or Latino
9
  15.5%
3
   6.4%
12
  11.4%
Not Hispanic or Latino
45
  77.6%
41
  87.2%
86
  81.9%
Unknown or Not Reported
4
   6.9%
3
   6.4%
7
   6.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 47 participants 105 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
21
  36.2%
15
  31.9%
36
  34.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  10.3%
8
  17.0%
14
  13.3%
White
29
  50.0%
24
  51.1%
53
  50.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
   3.4%
0
   0.0%
2
   1.9%
1.Primary Outcome
Title Number of Participants With an Adjudicated On-trial Relapse in the Primary Treatment Period
Hide Description An On-trial Relapse was defined as a new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change (clinical sign) on neurologic examination that persisted for more than 24 hours as confirmed by the treating physician. An adjudicated On-trial Relapse was defined by the protocol and positively adjudicated by the independent relapse adjudication committee.
Time Frame Baseline up to 2.25 years (end of the Primary Treatment Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).
Arm/Group Title Ravulizumab Placebo (ECU-NMO-301)
Hide Arm/Group Description:
Participants received a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years).
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Overall Number of Participants Analyzed 58 47
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
20
  42.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ravulizumab, Placebo (ECU-NMO-301)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.014
Confidence Interval (2-Sided) 95%
0.000 to 0.103
Estimation Comments HR based on a Cox proportional hazards model, with Firth's adjustment. Confidence interval (CI)= Wald CI or Profile Likelihood CI Limits. HR for ravulizumab compared with placebo presented a 98.6% reduction in risk of relapse, 95% CI (89.7%, 100.0%).
2.Secondary Outcome
Title Adjudicated On-trial Annualized Relapse Rate (ARR) in the Primary Treatment Period
Hide Description The adjudicated On-trial ARR was computed as the total number of relapses divided by the total number of participant years in the study period. A central independent committee was used to adjudicate all On-trial Relapses as determined by the treating physician. Results reported as adjusted adjudicated On-trial ARR based on a Poisson regression centered on the mean historical ARR in the 24 months prior to screening.
Time Frame Baseline up to 2.25 years (end of the Primary Treatment Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).
Arm/Group Title Ravulizumab Placebo (ECU-NMO-301)
Hide Arm/Group Description:
Participants received a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years).
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Overall Number of Participants Analyzed 58 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: relapses/year on study
0.000 [1] 
(NA to NA)
0.350
(0.199 to 0.616)
[1]
Since there were no relapses, data could not be estimated.
3.Secondary Outcome
Title Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) Score at the End of Primary Treatment Period
Hide Description The HAI is a rating scale developed to assess mobility by evaluating the time and degree of assistance required to walk 25 feet. The scale ranges from 0 to 9, with 0 being the best score (asymptomatic; fully ambulatory with no assistance) and 9 being the worst (restricted to wheelchair; unable to transfer self independently). Clinically important change is conditional on the baseline value: worsening if the baseline HAI is 0 and at least 2 points increase or if the baseline HAI is >0 and at least 1 point increase; improvement if the baseline value is at least 2 and at least 1 point decrease; and stable if baseline is 0 or 1 and a 0- or 1-point increase or decrease or baseline is at least 2 and not change.
Time Frame Baseline up to 2.25 years (end of the Primary Treatment Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).
Arm/Group Title Ravulizumab Placebo (ECU-NMO-301)
Hide Arm/Group Description:
Participants received a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years).
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Overall Number of Participants Analyzed 58 47
Measure Type: Count of Participants
Unit of Measure: Participants
Clinical Improvement
4
   6.9%
4
   8.5%
Stable
52
  89.7%
32
  68.1%
Clinical Worsening
2
   3.4%
11
  23.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ravulizumab, Placebo (ECU-NMO-301)
Comments The test of proportional odds was determined from a score test. The proportional odds was evaluated in univariate models.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0122
Comments Proportional Odds p-value
Method Univariate models
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in European Quality of Life Health 5-dimension Questionnaire (EQ-5D) Index Score at the End of Primary Treatment Period
Hide Description The EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. It consists of 2 parts; the EQ-5D descriptive system and the EQ-5D visual analogue scale (VAS). The EQ-5D descriptive system includes 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: "no problem" (level 1), "some problems" (level 2), "extreme problems" (level 3). The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. The 5 dimensional 3-level systems was converted into single index utility score that ranges from less than 0 to 1, with higher scores representing a better health status.
Time Frame Baseline, up to 2.25 years (end of the Primary Treatment Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).
Arm/Group Title Ravulizumab Placebo (ECU-NMO-301)
Hide Arm/Group Description:
Participants received a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years).
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Overall Number of Participants Analyzed 58 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.005  (0.1522) -0.043  (0.2115)
5.Secondary Outcome
Title Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score at the End of Primary Treatment Period
Hide Description The EQ-5D is a generic, standardized, self-administered instrument that provides a simple, descriptive profile and a single index value for health status. It consists of 2 parts; the EQ-5D descriptive system and the EQ-5D visual analogue scale (VAS). The EQ-5D VAS is an overall health state scale where the participant selects a number between 0 to 100 to describe the condition of their health, with 100 being 'The best health state you can imagine' and 0 being 'The worst health state you can imagine'. An increase in score indicates improvement.
Time Frame Baseline, up to 2.25 years (end of the Primary Treatment Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).
Arm/Group Title Ravulizumab Placebo (ECU-NMO-301)
Hide Arm/Group Description:
Participants received a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years).
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Overall Number of Participants Analyzed 58 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.6  (14.07) 0.6  (16.39)
6.Secondary Outcome
Title Number of Participants With Clinically Important Worsening From Baseline in Expanded Disability Status Scale (EDSS) Score at the End of Primary Treatment Period
Hide Description Disease-related disability was measured by the EDSS. The EDSS is an ordinal clinical rating scale that ranges from 0 (normal neurologic examination) to 10 (death) in half-point increments. Clinically important worsening was defined as an increase in EDSS score conditional on the baseline value: If the baseline EDSS was 0 and at least 2-point increase; if the baseline is 1 to 5, and at least 1-point increase; if the baseline is > 5 and at least 0.5 increase.
Time Frame Baseline up to 2.25 years (end of the Primary Treatment Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants who had received at least 1 dose of study drug (ravulizumab or placebo).
Arm/Group Title Ravulizumab Placebo (ECU-NMO-301)
Hide Arm/Group Description:
Participants received a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years).
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Overall Number of Participants Analyzed 58 47
Measure Type: Count of Participants
Unit of Measure: Participants
No clinically important worsening
52
  89.7%
36
  76.6%
Clinically important worsening
6
  10.3%
11
  23.4%
7.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs Leading to Study Drug Discontinuation in the Primary Treatment Period
Hide Description An 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, persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug), important medical event or reaction. TEAEs were AEs with a start date on or after the date of the first dose of study drug. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time Frame Baseline up to 2.25 years (end of the Primary Treatment Period)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo).
Arm/Group Title Ravulizumab Placebo (ECU-NMO-301)
Hide Arm/Group Description:
Participants received a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years).
Participants who received eculizumab matching placebo in study ECU-NMO-301.
Overall Number of Participants Analyzed 58 47
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAEs
53
  91.4%
45
  95.7%
TESAEs
8
  13.8%
26
  55.3%
TEAEs Leading to Study Drug Discontinuation
1
   1.7%
2
   4.3%
8.Secondary Outcome
Title Serum Ravulizumab Concentration
Hide Description [Not Specified]
Time Frame Predose and end of infusion (EOI) at Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics/pharmacodynamics (PK/PD) analysis set included participants who received at least 1 dose of study drug and who had at least 1 evaluable PK or PD result. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years).
Overall Number of Participants Analyzed 56
Mean (Standard Deviation)
Unit of Measure: micrograms (µg)/milliliter (mL)
Week 26: Predose Number Analyzed 55 participants
760.3  (202.75)
Week 26: EOI Number Analyzed 56 participants
1836.4  (355.39)
9.Secondary Outcome
Title Change From Baseline in Serum Free C5 Concentration at Week 26 and 50
Hide Description [Not Specified]
Time Frame Baseline, Week 26 (Predose and EOI)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK/PD analysis set included participants who received at least 1 dose of study drug and who had at least 1 evaluable PK or PD result. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable at specified timepoint.
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years).
Overall Number of Participants Analyzed 55
Mean (Standard Deviation)
Unit of Measure: µg/mL
Change at Week 26: Predose Number Analyzed 54 participants
-119.02  (42.857)
Change at Week 26: EOI Number Analyzed 55 participants
-119.32  (42.512)
10.Secondary Outcome
Title Number of Participants With Anti-drug Antibodies (ADAs) During the Primary Treatment Period
Hide Description [Not Specified]
Time Frame Baseline, Weeks 26, 50, 82, and 106
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo). Here, 'Number analyzed' = participants evaluable at specified timepoint.
Arm/Group Title Ravulizumab
Hide Arm/Group Description:
Participants received a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years).
Overall Number of Participants Analyzed 58
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 58 participants
Positive
5
   8.6%
Negative
53
  91.4%
Week 26 Number Analyzed 55 participants
Positive
1
   1.8%
Negative
54
  98.2%
Week 50 Number Analyzed 52 participants
Positive
0
   0.0%
Negative
52
 100.0%
Week 82 Number Analyzed 15 participants
Positive
0
   0.0%
Negative
15
 100.0%
Week 106 Number Analyzed 1 participants
Positive
0
   0.0%
Negative
1
 100.0%
Time Frame Baseline up to 2.25 years (end of the Primary Treatment Period)
Adverse Event Reporting Description The safety set included all participants who received at least 1 dose of study drug (ravulizumab or placebo).
 
Arm/Group Title Ravulizumab Placebo (ECU-NMO-301)
Hide Arm/Group Description Participants received a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until the end of primary treatment period (up to 2.25 years). Participants who received eculizumab matching placebo in study ECU-NMO-301.
All-Cause Mortality
Ravulizumab Placebo (ECU-NMO-301)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/47 (0.00%) 
Hide Serious Adverse Events
Ravulizumab Placebo (ECU-NMO-301)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/58 (13.79%)   26/47 (55.32%) 
Blood and lymphatic system disorders     
Pancytopenia † 1  0/58 (0.00%)  1/47 (2.13%) 
Cardiac disorders     
Myocardial ischaemia † 1  0/58 (0.00%)  1/47 (2.13%) 
Gastrointestinal disorders     
Abdominal pain † 1  0/58 (0.00%)  1/47 (2.13%) 
Pancreatitis † 1  0/58 (0.00%)  1/47 (2.13%) 
Hepatobiliary disorders     
Cholecystitis acute † 1  0/58 (0.00%)  1/47 (2.13%) 
Infections and infestations     
Encephalitis meningococcal † 1  1/58 (1.72%)  0/47 (0.00%) 
Infection † 1  1/58 (1.72%)  0/47 (0.00%) 
Intervertebral discitis † 1  1/58 (1.72%)  0/47 (0.00%) 
Meningococcal sepsis † 1  1/58 (1.72%)  0/47 (0.00%) 
Pneumonia † 1  1/58 (1.72%)  1/47 (2.13%) 
Bronchitis † 1  0/58 (0.00%)  1/47 (2.13%) 
Gastroenteritis viral † 1  0/58 (0.00%)  1/47 (2.13%) 
Herpes zoster † 1  0/58 (0.00%)  1/47 (2.13%) 
Influenza † 1  0/58 (0.00%)  1/47 (2.13%) 
Pneumococcal infection † 1  0/58 (0.00%)  1/47 (2.13%) 
Viral upper respiratory tract infection † 1  0/58 (0.00%)  1/47 (2.13%) 
Injury, poisoning and procedural complications     
Rib fracture † 1  0/58 (0.00%)  1/47 (2.13%) 
Musculoskeletal and connective tissue disorders     
Spinal osteoarthritis † 1  1/58 (1.72%)  0/47 (0.00%) 
Muscular weakness † 1  0/58 (0.00%)  1/47 (2.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Invasive lobular breast carcinoma † 1  1/58 (1.72%)  0/47 (0.00%) 
Adenocarcinoma † 1  0/58 (0.00%)  1/47 (2.13%) 
Nervous system disorders     
Myelitis transverse † 1  0/58 (0.00%)  1/47 (2.13%) 
Neuromyelitis optica spectrum disorder † 1  0/58 (0.00%)  16/47 (34.04%) 
Paraesthesia † 1  0/58 (0.00%)  1/47 (2.13%) 
Somnolence † 1  0/58 (0.00%)  1/47 (2.13%) 
Syncope † 1  0/58 (0.00%)  1/47 (2.13%) 
Psychiatric disorders     
Suicidal ideation † 1  1/58 (1.72%)  0/47 (0.00%) 
Confusional state † 1  0/58 (0.00%)  1/47 (2.13%) 
Respiratory, thoracic and mediastinal disorders     
Pleurisy † 1  0/58 (0.00%)  1/47 (2.13%) 
Pulmonary embolism † 1  0/58 (0.00%)  1/47 (2.13%) 
Respiratory disorder † 1  0/58 (0.00%)  1/47 (2.13%) 
Vascular disorders     
Orthostatic hypotension † 1  0/58 (0.00%)  1/47 (2.13%) 
1
Term from vocabulary, MedDRA 25.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ravulizumab Placebo (ECU-NMO-301)
Affected / at Risk (%) Affected / at Risk (%)
Total   53/58 (91.38%)   43/47 (91.49%) 
Blood and lymphatic system disorders     
Lymphadenopathy † 1  3/58 (5.17%)  1/47 (2.13%) 
Anaemia † 1  1/58 (1.72%)  1/47 (2.13%) 
Iron deficiency anaemia † 1  0/58 (0.00%)  1/47 (2.13%) 
Leukopenia † 1  0/58 (0.00%)  1/47 (2.13%) 
Cardiac disorders     
Tachycardia † 1  1/58 (1.72%)  0/47 (0.00%) 
Bradycardia † 1  0/58 (0.00%)  1/47 (2.13%) 
Extrasystoles † 1  0/58 (0.00%)  1/47 (2.13%) 
Pericardial effusion † 1  0/58 (0.00%)  1/47 (2.13%) 
Ear and labyrinth disorders     
Vertigo † 1  2/58 (3.45%)  1/47 (2.13%) 
Ear pain † 1  1/58 (1.72%)  2/47 (4.26%) 
Paraesthesia ear † 1  1/58 (1.72%)  0/47 (0.00%) 
Tinnitus † 1  1/58 (1.72%)  0/47 (0.00%) 
Vertigo positional † 1  1/58 (1.72%)  0/47 (0.00%) 
Eustachian tube dysfunction † 1  0/58 (0.00%)  1/47 (2.13%) 
Endocrine disorders     
Thyroid cyst † 1  1/58 (1.72%)  0/47 (0.00%) 
Thyroid mass † 1  1/58 (1.72%)  0/47 (0.00%) 
Eye disorders     
Blepharitis † 1  2/58 (3.45%)  0/47 (0.00%) 
Conjunctivitis allergic † 1  1/58 (1.72%)  1/47 (2.13%) 
Eye disorder † 1  1/58 (1.72%)  0/47 (0.00%) 
Eye pain † 1  1/58 (1.72%)  1/47 (2.13%) 
Ocular discomfort † 1  1/58 (1.72%)  0/47 (0.00%) 
Ocular hyperaemia † 1  1/58 (1.72%)  0/47 (0.00%) 
Vision blurred † 1  1/58 (1.72%)  1/47 (2.13%) 
Visual impairment † 1  1/58 (1.72%)  1/47 (2.13%) 
Cataract † 1  0/58 (0.00%)  2/47 (4.26%) 
Conjunctival haemorrhage † 1  0/58 (0.00%)  2/47 (4.26%) 
Photophobia † 1  0/58 (0.00%)  1/47 (2.13%) 
Retinal degeneration † 1  0/58 (0.00%)  1/47 (2.13%) 
Gastrointestinal disorders     
Constipation † 1  4/58 (6.90%)  3/47 (6.38%) 
Vomiting † 1  4/58 (6.90%)  8/47 (17.02%) 
Diarrhoea † 1  3/58 (5.17%)  6/47 (12.77%) 
Gastrooesophageal reflux disease † 1  3/58 (5.17%)  3/47 (6.38%) 
Nausea † 1  2/58 (3.45%)  12/47 (25.53%) 
Abdominal distension † 1  1/58 (1.72%)  0/47 (0.00%) 
Alveolar bone resorption † 1  1/58 (1.72%)  0/47 (0.00%) 
Anal incontinence † 1  1/58 (1.72%)  0/47 (0.00%) 
Dry mouth † 1  1/58 (1.72%)  1/47 (2.13%) 
Dyspepsia † 1  1/58 (1.72%)  4/47 (8.51%) 
Food poisoning † 1  1/58 (1.72%)  0/47 (0.00%) 
Gastric ulcer † 1  1/58 (1.72%)  0/47 (0.00%) 
Periodontal disease † 1  1/58 (1.72%)  0/47 (0.00%) 
Stomatitis † 1  1/58 (1.72%)  2/47 (4.26%) 
Abdominal pain † 1  0/58 (0.00%)  2/47 (4.26%) 
Abdominal pain upper † 1  0/58 (0.00%)  3/47 (6.38%) 
Abdominal tenderness † 1  0/58 (0.00%)  1/47 (2.13%) 
Angular cheilitis † 1  0/58 (0.00%)  1/47 (2.13%) 
Aphthous ulcer † 1  0/58 (0.00%)  1/47 (2.13%) 
Colitis microscopic † 1  0/58 (0.00%)  1/47 (2.13%) 
Gingival pain † 1  0/58 (0.00%)  1/47 (2.13%) 
Intestinal obstruction † 1  0/58 (0.00%)  1/47 (2.13%) 
Lip blister † 1  0/58 (0.00%)  1/47 (2.13%) 
Lip pain † 1  0/58 (0.00%)  1/47 (2.13%) 
Mouth ulceration † 1  0/58 (0.00%)  1/47 (2.13%) 
Presbyoesophagus † 1  0/58 (0.00%)  1/47 (2.13%) 
Toothache † 1  0/58 (0.00%)  2/47 (4.26%) 
General disorders     
Pyrexia † 1  5/58 (8.62%)  4/47 (8.51%) 
Chills † 1  3/58 (5.17%)  0/47 (0.00%) 
Fatigue † 1  3/58 (5.17%)  5/47 (10.64%) 
Malaise † 1  3/58 (5.17%)  0/47 (0.00%) 
Non-cardiac chest pain † 1  3/58 (5.17%)  0/47 (0.00%) 
Vaccination site pain † 1  3/58 (5.17%)  0/47 (0.00%) 
Asthenia † 1  2/58 (3.45%)  1/47 (2.13%) 
Pain † 1  2/58 (3.45%)  4/47 (8.51%) 
Chest discomfort † 1  1/58 (1.72%)  2/47 (4.26%) 
Chest pain † 1  1/58 (1.72%)  2/47 (4.26%) 
Inflammation † 1  1/58 (1.72%)  0/47 (0.00%) 
Influenza like illness † 1  1/58 (1.72%)  1/47 (2.13%) 
Injection site reaction † 1  1/58 (1.72%)  0/47 (0.00%) 
Swelling † 1  1/58 (1.72%)  1/47 (2.13%) 
Swelling face † 1  1/58 (1.72%)  0/47 (0.00%) 
Vaccination site pruritus † 1  1/58 (1.72%)  0/47 (0.00%) 
Feeling cold † 1  0/58 (0.00%)  1/47 (2.13%) 
Gait disturbance † 1  0/58 (0.00%)  1/47 (2.13%) 
Induration † 1  0/58 (0.00%)  1/47 (2.13%) 
Oedema † 1  0/58 (0.00%)  1/47 (2.13%) 
Oedema peripheral † 1  0/58 (0.00%)  3/47 (6.38%) 
Peripheral swelling † 1  0/58 (0.00%)  2/47 (4.26%) 
Hepatobiliary disorders     
Hepatic steatosis † 1  1/58 (1.72%)  0/47 (0.00%) 
Cholecystitis † 1  0/58 (0.00%)  1/47 (2.13%) 
Cholelithiasis † 1  0/58 (0.00%)  1/47 (2.13%) 
Hepatic function abnormal † 1  0/58 (0.00%)  1/47 (2.13%) 
Immune system disorders     
Immunisation reaction † 1  2/58 (3.45%)  1/47 (2.13%) 
Allergy to arthropod bite † 1  1/58 (1.72%)  0/47 (0.00%) 
Seasonal allergy † 1  0/58 (0.00%)  2/47 (4.26%) 
Infections and infestations     
COVID-19 † 1  14/58 (24.14%)  0/47 (0.00%) 
Urinary tract infection † 1  6/58 (10.34%)  9/47 (19.15%) 
Cystitis † 1  5/58 (8.62%)  1/47 (2.13%) 
Upper respiratory tract infection † 1  5/58 (8.62%)  6/47 (12.77%) 
Nasopharyngitis † 1  3/58 (5.17%)  8/47 (17.02%) 
Sinusitis † 1  3/58 (5.17%)  0/47 (0.00%) 
Conjunctivitis † 1  2/58 (3.45%)  4/47 (8.51%) 
Oral herpes † 1  2/58 (3.45%)  2/47 (4.26%) 
Periodontitis † 1  2/58 (3.45%)  0/47 (0.00%) 
Bronchitis † 1  1/58 (1.72%)  1/47 (2.13%) 
Cellulitis † 1  1/58 (1.72%)  0/47 (0.00%) 
Gingivitis † 1  1/58 (1.72%)  0/47 (0.00%) 
Herpes simplex † 1  1/58 (1.72%)  0/47 (0.00%) 
Laryngitis † 1  1/58 (1.72%)  0/47 (0.00%) 
Nasal herpes † 1  1/58 (1.72%)  0/47 (0.00%) 
Paronychia † 1  1/58 (1.72%)  0/47 (0.00%) 
Post-acute COVID-19 syndrome † 1  1/58 (1.72%)  0/47 (0.00%) 
Rhinitis † 1  1/58 (1.72%)  1/47 (2.13%) 
Stenotrophomonas infection † 1  1/58 (1.72%)  0/47 (0.00%) 
Tinea pedis † 1  1/58 (1.72%)  0/47 (0.00%) 
Tinea versicolour † 1  1/58 (1.72%)  0/47 (0.00%) 
Tooth infection † 1  1/58 (1.72%)  0/47 (0.00%) 
Viral pharyngitis † 1  1/58 (1.72%)  0/47 (0.00%) 
Vulvovaginal candidiasis † 1  1/58 (1.72%)  0/47 (0.00%) 
Bacterial vaginosis † 1  0/58 (0.00%)  1/47 (2.13%) 
Body tinea † 1  0/58 (0.00%)  1/47 (2.13%) 
Chronic tonsillitis † 1  0/58 (0.00%)  1/47 (2.13%) 
Diarrhoea infectious † 1  0/58 (0.00%)  1/47 (2.13%) 
Ear infection † 1  0/58 (0.00%)  1/47 (2.13%) 
Gastroenteritis † 1  0/58 (0.00%)  1/47 (2.13%) 
Influenza † 1  0/58 (0.00%)  1/47 (2.13%) 
Lower respiratory tract infection † 1  0/58 (0.00%)  1/47 (2.13%) 
Mastitis bacterial † 1  0/58 (0.00%)  1/47 (2.13%) 
Nail infection † 1  0/58 (0.00%)  1/47 (2.13%) 
Oesophageal candidiasis † 1  0/58 (0.00%)  1/47 (2.13%) 
Onychomycosis † 1  0/58 (0.00%)  1/47 (2.13%) 
Oral candidiasis † 1  0/58 (0.00%)  2/47 (4.26%) 
Otitis externa † 1  0/58 (0.00%)  1/47 (2.13%) 
Pharyngitis † 1  0/58 (0.00%)  3/47 (6.38%) 
Pneumonia † 1  0/58 (0.00%)  3/47 (6.38%) 
Post procedural infection † 1  0/58 (0.00%)  1/47 (2.13%) 
Tooth abscess † 1  0/58 (0.00%)  1/47 (2.13%) 
Viral upper respiratory tract infection † 1  0/58 (0.00%)  1/47 (2.13%) 
Vulvovaginal mycotic infection † 1  0/58 (0.00%)  1/47 (2.13%) 
Injury, poisoning and procedural complications     
Infusion related reaction † 1  4/58 (6.90%)  0/47 (0.00%) 
Alcohol poisoning † 1  1/58 (1.72%)  0/47 (0.00%) 
Cartilage injury † 1  1/58 (1.72%)  0/47 (0.00%) 
Concussion † 1  1/58 (1.72%)  0/47 (0.00%) 
Joint dislocation † 1  1/58 (1.72%)  0/47 (0.00%) 
Ligament sprain † 1  1/58 (1.72%)  1/47 (2.13%) 
Limb injury † 1  1/58 (1.72%)  1/47 (2.13%) 
Muscle strain † 1  1/58 (1.72%)  0/47 (0.00%) 
Post lumbar puncture syndrome † 1  1/58 (1.72%)  1/47 (2.13%) 
Rib fracture † 1  1/58 (1.72%)  2/47 (4.26%) 
Skin abrasion † 1  1/58 (1.72%)  2/47 (4.26%) 
Tooth fracture † 1  1/58 (1.72%)  0/47 (0.00%) 
Chillblains † 1  0/58 (0.00%)  1/47 (2.13%) 
Contusion † 1  0/58 (0.00%)  2/47 (4.26%) 
Dislocation of vertebra † 1  0/58 (0.00%)  1/47 (2.13%) 
Fall † 1  0/58 (0.00%)  4/47 (8.51%) 
Fibula fracture † 1  0/58 (0.00%)  1/47 (2.13%) 
Foot fracture † 1  0/58 (0.00%)  1/47 (2.13%) 
Fractured sacrum † 1  0/58 (0.00%)  1/47 (2.13%) 
Head injury † 1  0/58 (0.00%)  1/47 (2.13%) 
Injury † 1  0/58 (0.00%)  1/47 (2.13%) 
Post procedural contusion † 1  0/58 (0.00%)  1/47 (2.13%) 
Procedural complication † 1  0/58 (0.00%)  1/47 (2.13%) 
Skin laceration † 1  0/58 (0.00%)  2/47 (4.26%) 
Stress fracture † 1  0/58 (0.00%)  1/47 (2.13%) 
Thermal burn † 1  0/58 (0.00%)  1/47 (2.13%) 
Thoracic vertebral fracture † 1  0/58 (0.00%)  1/47 (2.13%) 
Wound † 1  0/58 (0.00%)  2/47 (4.26%) 
Investigations     
Hepatic enzyme increased † 1  2/58 (3.45%)  1/47 (2.13%) 
Lymphocyte count decreased † 1  2/58 (3.45%)  1/47 (2.13%) 
Alanine aminotransferase increased † 1  1/58 (1.72%)  0/47 (0.00%) 
Aspartate aminotransferase increased † 1  1/58 (1.72%)  1/47 (2.13%) 
Blood creatinine increased † 1  1/58 (1.72%)  1/47 (2.13%) 
Haemoglobin decreased † 1  1/58 (1.72%)  2/47 (4.26%) 
SARS-CoV-2 test positive † 1  1/58 (1.72%)  0/47 (0.00%) 
Urinary occult blood † 1  1/58 (1.72%)  0/47 (0.00%) 
Blood potassium decreased † 1  0/58 (0.00%)  1/47 (2.13%) 
Blood pressure systolic increased † 1  0/58 (0.00%)  1/47 (2.13%) 
Bone density decreased † 1  0/58 (0.00%)  1/47 (2.13%) 
Cortisol decreased † 1  0/58 (0.00%)  1/47 (2.13%) 
Electrocardiogram abnormal † 1  0/58 (0.00%)  1/47 (2.13%) 
Enterococcus test positive † 1  0/58 (0.00%)  1/47 (2.13%) 
Gardnerella test positive † 1  0/58 (0.00%)  1/47 (2.13%) 
Klebsiella test positive † 1  0/58 (0.00%)  1/47 (2.13%) 
Neutrophil count decreased † 1  0/58 (0.00%)  1/47 (2.13%) 
Weight decreased † 1  0/58 (0.00%)  3/47 (6.38%) 
Weight increased † 1  0/58 (0.00%)  1/47 (2.13%) 
White blood cell count decreased † 1  0/58 (0.00%)  1/47 (2.13%) 
Metabolism and nutrition disorders     
Hyperglycaemia † 1  2/58 (3.45%)  1/47 (2.13%) 
Hypercholesterolaemia † 1  1/58 (1.72%)  1/47 (2.13%) 
Hypokalaemia † 1  1/58 (1.72%)  1/47 (2.13%) 
Vitamin D deficiency † 1  1/58 (1.72%)  1/47 (2.13%) 
Decreased appetite † 1  0/58 (0.00%)  1/47 (2.13%) 
Dehydration † 1  0/58 (0.00%)  1/47 (2.13%) 
Folate deficiency † 1  0/58 (0.00%)  1/47 (2.13%) 
Hypophosphataemia † 1  0/58 (0.00%)  1/47 (2.13%) 
Hypoproteinaemia † 1  0/58 (0.00%)  2/47 (4.26%) 
Iron deficiency † 1  0/58 (0.00%)  1/47 (2.13%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  7/58 (12.07%)  6/47 (12.77%) 
Arthralgia † 1  6/58 (10.34%)  4/47 (8.51%) 
Myalgia † 1  3/58 (5.17%)  3/47 (6.38%) 
Muscle contracture † 1  2/58 (3.45%)  0/47 (0.00%) 
Neck pain † 1  2/58 (3.45%)  2/47 (4.26%) 
Pain in extremity † 1  2/58 (3.45%)  10/47 (21.28%) 
Joint swelling † 1  1/58 (1.72%)  0/47 (0.00%) 
Limb discomfort † 1  1/58 (1.72%)  0/47 (0.00%) 
Muscle spasms † 1  1/58 (1.72%)  2/47 (4.26%) 
Musculoskeletal discomfort † 1  1/58 (1.72%)  0/47 (0.00%) 
Pelvic deformity † 1  1/58 (1.72%)  0/47 (0.00%) 
Periarthritis † 1  1/58 (1.72%)  0/47 (0.00%) 
Rheumatoid arthritis † 1  1/58 (1.72%)  0/47 (0.00%) 
Flank pain † 1  0/58 (0.00%)  2/47 (4.26%) 
Fracture pain † 1  0/58 (0.00%)  1/47 (2.13%) 
Intervertebral disc protrusion † 1  0/58 (0.00%)  2/47 (4.26%) 
Muscular weakness † 1  0/58 (0.00%)  2/47 (4.26%) 
Musculoskeletal chest pain † 1  0/58 (0.00%)  1/47 (2.13%) 
Osteonecrosis † 1  0/58 (0.00%)  2/47 (4.26%) 
Osteopenia † 1  0/58 (0.00%)  1/47 (2.13%) 
Osteoporosis † 1  0/58 (0.00%)  2/47 (4.26%) 
Synovial disorder † 1  0/58 (0.00%)  1/47 (2.13%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm skin † 1  1/58 (1.72%)  0/47 (0.00%) 
Skin papilloma † 1  1/58 (1.72%)  0/47 (0.00%) 
Uterine leiomyoma † 1  1/58 (1.72%)  0/47 (0.00%) 
Anogenital warts † 1  0/58 (0.00%)  1/47 (2.13%) 
Basal cell carcinoma † 1  0/58 (0.00%)  1/47 (2.13%) 
Colorectal adenoma † 1  0/58 (0.00%)  1/47 (2.13%) 
Melanocytic naevus † 1  0/58 (0.00%)  1/47 (2.13%) 
Nervous system disorders     
Headache † 1  14/58 (24.14%)  10/47 (21.28%) 
Dizziness † 1  4/58 (6.90%)  6/47 (12.77%) 
Migraine † 1  3/58 (5.17%)  0/47 (0.00%) 
Paraesthesia † 1  2/58 (3.45%)  3/47 (6.38%) 
Hypoaesthesia † 1  1/58 (1.72%)  4/47 (8.51%) 
Memory impairment † 1  1/58 (1.72%)  1/47 (2.13%) 
Parosmia † 1  1/58 (1.72%)  0/47 (0.00%) 
Presyncope † 1  1/58 (1.72%)  0/47 (0.00%) 
Sensory disturbance † 1  1/58 (1.72%)  0/47 (0.00%) 
Somnolence † 1  1/58 (1.72%)  1/47 (2.13%) 
Syncope † 1  1/58 (1.72%)  0/47 (0.00%) 
Burning sensation † 1  0/58 (0.00%)  1/47 (2.13%) 
Dysgeusia † 1  0/58 (0.00%)  2/47 (4.26%) 
Head discomfort † 1  0/58 (0.00%)  1/47 (2.13%) 
Mental impairment † 1  0/58 (0.00%)  1/47 (2.13%) 
Muscle contractions involuntary † 1  0/58 (0.00%)  1/47 (2.13%) 
Muscle spasticity † 1  0/58 (0.00%)  1/47 (2.13%) 
Neuralgia † 1  0/58 (0.00%)  1/47 (2.13%) 
Post herpetic neuralgia † 1  0/58 (0.00%)  1/47 (2.13%) 
Uhthoff's phenomenon † 1  0/58 (0.00%)  1/47 (2.13%) 
Psychiatric disorders     
Anxiety † 1  2/58 (3.45%)  1/47 (2.13%) 
Insomnia † 1  2/58 (3.45%)  4/47 (8.51%) 
Depressed mood † 1  1/58 (1.72%)  0/47 (0.00%) 
Depression † 1  1/58 (1.72%)  4/47 (8.51%) 
Post-traumatic stress disorder † 1  1/58 (1.72%)  0/47 (0.00%) 
Sleep talking † 1  1/58 (1.72%)  0/47 (0.00%) 
Suicidal ideation † 1  1/58 (1.72%)  0/47 (0.00%) 
Agitation † 1  0/58 (0.00%)  1/47 (2.13%) 
Delusion † 1  0/58 (0.00%)  1/47 (2.13%) 
Hallucination † 1  0/58 (0.00%)  1/47 (2.13%) 
Obsessive-compulsive disorder † 1  0/58 (0.00%)  1/47 (2.13%) 
Persistent depressive disorder † 1  0/58 (0.00%)  1/47 (2.13%) 
Sleep disorder † 1  0/58 (0.00%)  2/47 (4.26%) 
Renal and urinary disorders     
Dysuria † 1  2/58 (3.45%)  0/47 (0.00%) 
Acute kidney injury † 1  1/58 (1.72%)  1/47 (2.13%) 
Haematuria † 1  1/58 (1.72%)  1/47 (2.13%) 
Proteinuria † 1  1/58 (1.72%)  0/47 (0.00%) 
Strangury † 1  1/58 (1.72%)  0/47 (0.00%) 
Cystitis interstitial † 1  0/58 (0.00%)  1/47 (2.13%) 
Glycosuria † 1  0/58 (0.00%)  1/47 (2.13%) 
Nephrolithiasis † 1  0/58 (0.00%)  1/47 (2.13%) 
Pollakiuria † 1  0/58 (0.00%)  2/47 (4.26%) 
Prerenal failure † 1  0/58 (0.00%)  1/47 (2.13%) 
Urethral syndrome † 1  0/58 (0.00%)  1/47 (2.13%) 
Urinary incontinence † 1  0/58 (0.00%)  1/47 (2.13%) 
Reproductive system and breast disorders     
Menopausal symptoms † 1  1/58 (1.72%)  1/47 (2.13%) 
Vulvovaginal pruritus † 1  1/58 (1.72%)  0/47 (0.00%) 
Dysmenorrhoea † 1  0/58 (0.00%)  2/47 (4.26%) 
Endometrial hyperplasia † 1  0/58 (0.00%)  1/47 (2.13%) 
Menstruation irregular † 1  0/58 (0.00%)  2/47 (4.26%) 
Oligomenorrhoea † 1  0/58 (0.00%)  1/47 (2.13%) 
Suppressed lactation † 1  0/58 (0.00%)  1/47 (2.13%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1  3/58 (5.17%)  6/47 (12.77%) 
Dyspnoea † 1  1/58 (1.72%)  1/47 (2.13%) 
Epistaxis † 1  1/58 (1.72%)  1/47 (2.13%) 
Hiccups † 1  1/58 (1.72%)  0/47 (0.00%) 
Obstructive sleep apnoea syndrome † 1  1/58 (1.72%)  0/47 (0.00%) 
Rhinitis allergic † 1  1/58 (1.72%)  3/47 (6.38%) 
Sinus congestion † 1  1/58 (1.72%)  0/47 (0.00%) 
Atelectasis † 1  0/58 (0.00%)  1/47 (2.13%) 
Chronic obstructive pulmonary disease † 1  0/58 (0.00%)  1/47 (2.13%) 
Dysphonia † 1  0/58 (0.00%)  1/47 (2.13%) 
Nasal congestion † 1  0/58 (0.00%)  3/47 (6.38%) 
Nasal discomfort † 1  0/58 (0.00%)  1/47 (2.13%) 
Oropharyngeal pain † 1  0/58 (0.00%)  2/47 (4.26%) 
Productive cough † 1  0/58 (0.00%)  1/47 (2.13%) 
Respiratory disorder † 1  0/58 (0.00%)  1/47 (2.13%) 
Rhinorrhoea † 1  0/58 (0.00%)  1/47 (2.13%) 
Sinus disorder † 1  0/58 (0.00%)  1/47 (2.13%) 
Tonsillolith † 1  0/58 (0.00%)  1/47 (2.13%) 
Upper-airway cough syndrome † 1  0/58 (0.00%)  1/47 (2.13%) 
Skin and subcutaneous tissue disorders     
Acne † 1  2/58 (3.45%)  1/47 (2.13%) 
Alopecia † 1  2/58 (3.45%)  2/47 (4.26%) 
Rash † 1  2/58 (3.45%)  4/47 (8.51%) 
Dermatitis † 1  1/58 (1.72%)  1/47 (2.13%) 
Dry skin † 1  1/58 (1.72%)  2/47 (4.26%) 
Eczema † 1  1/58 (1.72%)  1/47 (2.13%) 
Erythema † 1  1/58 (1.72%)  1/47 (2.13%) 
Hyperkeratosis † 1  1/58 (1.72%)  0/47 (0.00%) 
Ingrowing nail † 1  1/58 (1.72%)  0/47 (0.00%) 
Pruritus † 1  1/58 (1.72%)  4/47 (8.51%) 
Psoriasis † 1  1/58 (1.72%)  0/47 (0.00%) 
Sensitive skin † 1  1/58 (1.72%)  0/47 (0.00%) 
Urticaria † 1  1/58 (1.72%)  2/47 (4.26%) 
Dermatitis allergic † 1  0/58 (0.00%)  1/47 (2.13%) 
Dermatitis contact † 1  0/58 (0.00%)  2/47 (4.26%) 
Hyperhidrosis † 1  0/58 (0.00%)  1/47 (2.13%) 
Petechiae † 1  0/58 (0.00%)  1/47 (2.13%) 
Pityriasis rosea † 1  0/58 (0.00%)  1/47 (2.13%) 
Purpura † 1  0/58 (0.00%)  1/47 (2.13%) 
Rash maculo-papular † 1  0/58 (0.00%)  1/47 (2.13%) 
Skin irritation † 1  0/58 (0.00%)  1/47 (2.13%) 
Skin lesion † 1  0/58 (0.00%)  1/47 (2.13%) 
Social circumstances     
Menopause † 1  0/58 (0.00%)  1/47 (2.13%) 
Vascular disorders     
Hypertension † 1  2/58 (3.45%)  2/47 (4.26%) 
Deep vein thrombosis † 1  1/58 (1.72%)  0/47 (0.00%) 
Lymphoedema † 1  1/58 (1.72%)  0/47 (0.00%) 
Flushing † 1  0/58 (0.00%)  1/47 (2.13%) 
Hypotension † 1  0/58 (0.00%)  2/47 (4.26%) 
Orthostatic hypotension † 1  0/58 (0.00%)  1/47 (2.13%) 
1
Term from vocabulary, MedDRA 25.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Alexion Pharmaceuticals, Inc.
Organization: Alexion Pharmaceuticals, Inc.
Phone: 855-752-2356
EMail: clinicaltrials@alexion.com
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Responsible Party: Alexion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04201262    
Other Study ID Numbers: ALXN1210-NMO-307
CHAMPION-NMO-307 ( Other Identifier: Alexion Pharmaceuticals )
First Submitted: December 11, 2019
First Posted: December 17, 2019
Results First Submitted: May 31, 2023
Results First Posted: August 9, 2023
Last Update Posted: August 9, 2023