A Study to Assess the Safety and Efficacy of Inclacumab i... | NCT04935879

ID	Type	Description	Link
2020-005286-13	EudraCT Number
C5361001	Other Identifier	Alias Study Number

Label	Type	Description	Intervention Names
inclacumab, 30 mg/kg	Experimental	Participants will receive inclacumab 30 mg/kg administered IV every 12 weeks	Drug: Inclacumab
placebo	Placebo Comparator	Participants will receive placebo administered IV every 12 weeks.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Inclacumab	Drug	Inclacumab will be supplied in single use 10 mL vials at a concentration of 50 mg/mL. One vial contains 500 mg of inclacumab. This is a liquid concentrate for IV infusion.

Measure	Description	Time Frame
Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48	A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. The rate of VOC was defined as number of VOC events per 48 weeks and presented in this outcome measure.	Randomization (Day 1) up to Week 48

Measure	Description	Time Frame
Time to First VOC Through Week 48	A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Time to first VOC was the time between randomization date and onset date of first VOC event during 48 weeks. Kaplan-Meier method was used for estimation.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant has a confirmed diagnosis of SCD (HbSS, HbSC, HbSB0 thalassemia, or HbSB+ thalassemia genotype).

Documentation of SCD genotype is required and may be based on documented history of laboratory testing or confirmed by laboratory testing during Screening.
Participant is male or female, ≥ 12 years of age at the time of informed consent.
Participant has experienced between 2 and 10 VOCs within the 12 months prior to the Screening Visit as determined by documented medical history. A prior VOC is defined as an acute episode of pain which:
- Has no medically determined cause other than a vaso-occlusive event, and
- Results in a visit to a medical facility (hospital, emergency department, urgent care center, outpatient clinic, or infusion center) or results in a remote contact with a healthcare provider; and
- Requires parenteral narcotic agents, parenteral nonsteroidal anti- inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics.
Participants receiving erythropoiesis-stimulating agents (ESA, e.g., erythropoietin [EPO]) must be on a stable dose for at least 90 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.
Participants receiving hydroxyurea (HU), L-glutamine, or voxelotor (Oxbryta®) must be on a stable dose for at least 30 days prior to the Screening Visit and expected to continue with the stabilized regimen throughout the course of the study.

Exclusion Criteria:

Participant is receiving regularly scheduled red blood cell (RBC) transfusion therapy (also termed chronic, prophylactic, or preventative transfusion).
Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days prior to the Screening Visit
Participant weighs > 133 kg (292 lbs.).

Other protocol-defined Inclusion/Exclusion may apply.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of South Alabama Children's and Women's Hospital		Mobile	Alabama	36604	United States

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Inclacumab	Participants with sickle cell disease (SCD) were randomized to receive inclacumab at a dose of 30 milligram/kilogram (mg/kg) intravenously (IV) on Day 1 and once every 12 weeks (Q12W) on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an open-label extension (OLE) study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 14, 2023	Oct 29, 2025

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Rate of Vaso-occlusive Crises (VOCs) [Adjudicated] Through Week 48

A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral nonsteroidal anti-inflammatory drugs (NSAIDs), or an increase in treatment with oral narcotics. The rate of VOC was defined as number of VOC events per 48 weeks and presented in this outcome measure.

The ITT population included all randomized participants.

Posted

Number

95% Confidence Interval

Events per 48 weeks

Randomization (Day 1) up to Week 48

ID	Title	Description
OG000	Inclacumab	Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
OG001	Placebo	Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.

Units	Counts
Participants	OG000119 OG001122

Title

Denominators

Categories

Title	Measurements
	OG0001.49(1.22 to 1.83) OG0011.58(1.30 to 1.93)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Adjusted rates are based on estimate from a negative binomial model with the independent variable of treatment group (inclacumab, placebo) and adjusted for baseline hydroxyurea (HU) use (yes, no), number of VOCs in 12 months prior to screening visit (2-4, 5-10), and geographic region (North America, sub-Saharan Africa, Europe/rest of world).	Negative binomial regression model		0.6967		Rate ratio	0.95			2-Sided	95	0.71	1.25			Rate ratio = Ratio of rate of VOC for inclacumab group to placebo group.		Superiority

Secondary

Time to First VOC Through Week 48

A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Time to first VOC was the time between randomization date and onset date of first VOC event during 48 weeks. Kaplan-Meier method was used for estimation.

The ITT population included all randomized participants.

Posted

Median

95% Confidence Interval

Weeks

Randomization (Day 1) up to Week 48

ID	Title	Description
OG000	Inclacumab	Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
OG001	Placebo	Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.

Secondary

Time to Second VOC Through Week 48

A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Time to second VOC was the time between randomization date and onset date of second VOC event during 48 weeks. Kaplan-Meier method was used for estimation.

The ITT population included all randomized participants.

Posted

Median

95% Confidence Interval

Weeks

Randomization (Day 1) up to Week 48

ID	Title	Description
OG000	Inclacumab	Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
OG001	Placebo	Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.

Secondary

Percentage of Participants With no VOCs Through Week 48

A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility (hospitalization, emergency department, urgent care center, outpatient clinic, or infusion center), or resulted in a remote contact with a healthcare provider and required parenteral narcotic agents, parenteral NSAIDs, or an increase in treatment with oral narcotics. Participants without an observed VOC who discontinued the study prior to the end of the 48-week treatment period were assumed to had experienced at least one VOC.

The ITT population included all randomized participants.

Posted

Number

95% Confidence Interval

Percentage of participants

Randomization (Day 1) up to Week 48

ID	Title	Description
OG000	Inclacumab	Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
OG001	Placebo	Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.

Secondary

Rate of VOCs Required Admission to a Healthcare Facility and Treatment With Parenteral Pain Medication [Adjudicated] Through Week 48

A VOC that required admission to a healthcare facility and treatment with parenteral pain medication where admission included: a hospital admission or an admission to an emergency room, observation unit, or infusion center for >= 12 hours, or 2 visits to an emergency room, observation unit, or infusion center over a 72-hour period. The rate of VOC was defined as number of VOC events per 48 weeks; rate of VOCs which required admission to a healthcare facility and treatment with parenteral pain medication is presented in this outcome measure.

The ITT population included all randomized participants.

Posted

Number

95% Confidence Interval

Events per 48 weeks

Randomization (Day 1) up to Week 48

ID	Title	Description
OG000	Inclacumab	Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
OG001	Placebo	Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.

Secondary

Rate of Inpatient Hospitalization Days for a VOC Through Week 48

A VOC was defined as an acute episode of pain that: had no medically determined cause other than a vaso-occlusive event; resulted in a visit to a medical facility hospitalization. For each VOC event requiring inpatient hospitalization (regardless of treatment received) during the 48-week, the number of days hospitalized were determined based on the hospital admission and discharge dates. The rate of inpatient hospitalization days was defined as number of inpatient hospitalization days for a VOC per 48 weeks and presented in this outcome measure.

The ITT population included all randomized participants.

Posted

Number

95% Confidence Interval

Hospitalization days per 48 weeks

Randomization (Day 1) up to Week 48

ID	Title	Description
OG000	Inclacumab	Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
OG001	Placebo	Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product during the course of a clinical investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not thought to be related to the investigational product. A TEAE was defined as an AE with an onset after the initiation of dosing for the first dose of study drug. A serious adverse events (SAE) or serious suspected adverse reaction is an AE or suspected adverse reaction that, at any dose, in the view of the either the investigator or sponsor, results in any of the following outcomes: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization and congenital anomaly/birth defect. AEs included both serious and all non-SAEs.

Safety population included randomized participants who received treatment with study drug.

Posted

Count of Participants

Participants

Day 1 up to Week 60 (12 week of follow-up post Week 48)

ID	Title	Description
OG000	Inclacumab	Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
OG001

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0018 affected121 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Sickle cell anaemia with crisis	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Pyrexia	General disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Malaria	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0005 affected118 at risk EG0017 affected121 at risk
Pneumonia	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0005 affected118 at risk EG0015 affected121 at risk
Bacterial infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0013 affected121 at risk
Urinary tract infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0011 affected121 at risk
Atypical pneumonia	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
COVID-19	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Catheter site infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Escherichia bacteraemia	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Respiratory tract infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Respiratory tract infection viral	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Septic shock	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Cystitis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Gastroenteritis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Lower respiratory tract infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Tonsillitis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Upper respiratory tract infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Migraine	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Sciatica	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Disorientation	Psychiatric disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Urethral stenosis	Renal and urinary disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0010 affected121 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Deep vein thrombosis	Vascular disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Sickle cell anaemia with crisis	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG00021 affected118 at risk EG00121 affected121 at risk
Anaemia	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0005 affected118 at risk EG0019 affected121 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0004 affected118 at risk EG0010 affected121 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0010 affected121 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0012 affected121 at risk
Neutrophilia	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Tachycardia	Cardiac disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0010 affected121 at risk
Cor pulmonale acute	Cardiac disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Palpitations	Cardiac disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Cardiomegaly	Cardiac disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Ear pain	Ear and labyrinth disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Vertigo	Ear and labyrinth disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Thyroid mass	Endocrine disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Conjunctivitis allergic	Eye disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Pterygium	Eye disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Vision blurred	Eye disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Photophobia	Eye disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Retinopathy sickle cell	Eye disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Nausea	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0007 affected118 at risk EG0011 affected121 at risk
Diarrhoea	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0005 affected118 at risk EG0012 affected121 at risk
Abdominal pain	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0013 affected121 at risk
Vomiting	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0011 affected121 at risk
Abdominal distension	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0011 affected121 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0012 affected121 at risk
Constipation	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0011 affected121 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0011 affected121 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0011 affected121 at risk
Toothache	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0010 affected121 at risk
Flatulence	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Reflux gastritis	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Tooth disorder	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Dental caries	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Dry mouth	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Dyspepsia	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0012 affected121 at risk
Gastritis	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Stomatitis	Gastrointestinal disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Pyrexia	General disorders	MedDRAv28.0	Systematic Assessment	EG0007 affected118 at risk EG0014 affected121 at risk
Pain	General disorders	MedDRAv28.0	Systematic Assessment	EG0006 affected118 at risk EG0015 affected121 at risk
Non-cardiac chest pain	General disorders	MedDRAv28.0	Systematic Assessment	EG0004 affected118 at risk EG0011 affected121 at risk
Fatigue	General disorders	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0012 affected121 at risk
Asthenia	General disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0011 affected121 at risk
Chest pain	General disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0010 affected121 at risk
Chest discomfort	General disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Gait disturbance	General disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Influenza like illness	General disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Malaise	General disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Oedema peripheral	General disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Injury associated with device	General disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Peripheral swelling	General disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Sluggishness	General disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Swelling	General disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Cholecystitis	Hepatobiliary disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Cholestasis	Hepatobiliary disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Hepatic cytolysis	Hepatobiliary disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0012 affected121 at risk
Ocular icterus	Hepatobiliary disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Seasonal allergy	Immune system disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0010 affected121 at risk
Hypersensitivity	Immune system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Malaria	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG00018 affected118 at risk EG00124 affected121 at risk
Nasopharyngitis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0009 affected118 at risk EG0012 affected121 at risk
Upper respiratory tract infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0009 affected118 at risk EG00112 affected121 at risk
COVID-19	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0004 affected118 at risk EG0013 affected121 at risk
Urinary tract infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0004 affected118 at risk EG0014 affected121 at risk
Gastroenteritis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0013 affected121 at risk
Influenza	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0012 affected121 at risk
Pneumonia	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0013 affected121 at risk
Respiratory tract infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0012 affected121 at risk
Bacteraemia	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Cellulitis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Cystitis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Fungal infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Gastroenteritis viral	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Herpes simplex reactivation	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Hordeolum	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Lower respiratory tract infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Otitis media acute	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Pharyngitis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0013 affected121 at risk
Sepsis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Sinusitis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Tonsillitis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0017 affected121 at risk
Vulvovaginitis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Bacterial infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0018 affected121 at risk
Bronchitis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Conjunctivitis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Herpes zoster	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Infected skin ulcer	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Oral herpes	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Parainfluenzae virus infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Pneumonia bacterial	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Skin infection	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Tooth abscess	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Wound sepsis	Infections and infestations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Contusion	Injury, poisoning and procedural complications	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Concussion	Injury, poisoning and procedural complications	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Fall	Injury, poisoning and procedural complications	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0012 affected121 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Vascular access site pruritus	Injury, poisoning and procedural complications	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
C-reactive protein increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0013 affected121 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0011 affected121 at risk
Fibrin D dimer increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0010 affected121 at risk
Platelet count decreased	Investigations	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0010 affected121 at risk
Alanine aminotransferase increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Aspartate aminotransferase increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Blood bilirubin increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0012 affected121 at risk
Blood creatine phosphokinase increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Blood creatinine increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Blood fibrinogen decreased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Blood glucose increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Blood potassium increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
C-reactive protein	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Coagulation test abnormal	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Hepatic enzyme increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Neutrophil count abnormal	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Platelet count increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Protein total decreased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Prothrombin time shortened	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Reticulocyte count increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Reticulocyte percentage increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Serum ferritin increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Weight decreased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
White blood cell count increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Blood iron decreased	Investigations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Haemoglobin decreased	Investigations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
International normalised ratio increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Neutrophil count increased	Investigations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Oxygen saturation decreased	Investigations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Prothrombin time prolonged	Investigations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
SARS-CoV-2 test positive	Investigations	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0013 affected121 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Hyperferritinaemia	Metabolism and nutrition disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Dehydration	Metabolism and nutrition disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRAv28.0	Systematic Assessment	EG00015 affected118 at risk EG00112 affected121 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRAv28.0	Systematic Assessment	EG00010 affected118 at risk EG00114 affected121 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRAv28.0	Systematic Assessment	EG0007 affected118 at risk EG0015 affected121 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRAv28.0	Systematic Assessment	EG0004 affected118 at risk EG0013 affected121 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0012 affected121 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0012 affected121 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Headache	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG00016 affected118 at risk EG00121 affected121 at risk
Migraine	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0011 affected121 at risk
Ageusia	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Amnesia	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Amputation stump pain	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Dizziness	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0013 affected121 at risk
Paraesthesia	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Psychogenic seizure	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Syncope	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Epilepsy	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Hypoaesthesia	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Somnolence	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Anxiety	Psychiatric disorders	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0010 affected121 at risk
Depression	Psychiatric disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0012 affected121 at risk
Insomnia	Psychiatric disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Acute kidney injury	Renal and urinary disorders	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0010 affected121 at risk
Dysuria	Renal and urinary disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Nephropathy	Renal and urinary disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Pollakiuria	Renal and urinary disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Proteinuria	Renal and urinary disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Priapism	Reproductive system and breast disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0012 affected121 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0010 affected121 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Heavy menstrual bleeding	Reproductive system and breast disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Penile swelling	Reproductive system and breast disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0013 affected121 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0010 affected121 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0016 affected121 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0010 affected121 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRAv28.0	Systematic Assessment	EG0004 affected118 at risk EG0011 affected121 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0010 affected121 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0011 affected121 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0010 affected121 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRAv28.0	Systematic Assessment	EG0002 affected118 at risk EG0010 affected121 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Pruritus allergic	Skin and subcutaneous tissue disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0011 affected121 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Pityriasis alba	Skin and subcutaneous tissue disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk
Hypotension	Vascular disorders	MedDRAv28.0	Systematic Assessment	EG0003 affected118 at risk EG0011 affected121 at risk
Flushing	Vascular disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Haematoma	Vascular disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Hyperaemia	Vascular disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Phlebitis	Vascular disorders	MedDRAv28.0	Systematic Assessment	EG0001 affected118 at risk EG0010 affected121 at risk
Hypertension	Vascular disorders	MedDRAv28.0	Systematic Assessment	EG0000 affected118 at risk EG0011 affected121 at risk

ID	Term
D000755	Anemia, Sickle Cell
D000098644	Vaso-Occlusive Crises
D006402	Hematologic Diseases
D012805	Sickle Cell Trait

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006425	Hemic and Lymphatic Diseases
D006453	Hemoglobinopathies
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Title	Description
BG000	Inclacumab	Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
BG001	Placebo	Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Inclacumab	Participants with SCD were randomized to receive inclacumab at a dose of 30 mg/kg IV on Day 1 and Q12W on Weeks 12, 24 and 36.Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.	3	118	23	118	83	118
EG001	Placebo	Participants with SCD were randomized to receive placebo matched to inclacumab IV on Day 1 and Q12W on Weeks 12, 24 and 36. Participants were followed up till Week 48 and was part of "48-Week Treatment Period". Participants at Week 48 had a choice to either enter an OLE study (under a separate protocol) to receive inclacumab or were followed up for another 12 weeks i.e. Week 60.	2	121	27	121	90	121