A Study to Evaluate the Efficacy and Safety of VIB4920 in... | NCT04129164

ID	Type	Description	Link
2019-002713-19	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VIB4920 Dose 1 in Population 1	Experimental	Participants in population 1 will receive IV VIB4920 Dose 1 in Stage I and placebo matched to VIB4920 in Stage II.	Drug: VIB4920 Drug: Placebo
Placebo in Population 1	Placebo Comparator	Participants in population 1 will receive IV placebo matched to VIB4920 in Stage I and IV VIB4920 Dose 1 in Stage II.	Drug: VIB4920 Drug: Placebo
VIB4920 Dose 1 in Population 2	Experimental	Participants in population 2 will receive IV VIB4920 Dose 1 in Stage I and placebo matched to VIB4920 in Stage II.	Drug: VIB4920 Drug: Placebo
Placebo in Population 2	Placebo Comparator	Participants in population 2 will receive IV placebo matched to VIB4920 in Stage I and IV VIB4920 Dose 1 in Stage II.	Drug: VIB4920 Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
VIB4920	Drug	Intravenous Dose 1.	Placebo in Population 1 Placebo in Population 2 VIB4920 Dose 1 in Population 1 VIB4920 Dose 1 in Population 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Population 1: Change From Baseline in ESSDAI at Day 169	The ESSDAI is a systemic disease activity index for SS, assessing 12 domains (Constitutional, Salivary Glands, Lungs, Kidneys, Musculoskeletal, Peripheral Nervous System, Central Nervous System, Vascular, Gastrointestinal, Hematological, Ocular, and Extraglandular Manifestations). Each domain is graded for activity (0 = no activity to 3 = high activity) and weighted (1 for Biological to 6 for Muscular) based on its clinical significance, with the final score calculated as the sum of all weighted domain scores. The theoretical range is 0 to 123, with disease activity categorized as low (<5), moderate (5-13), and high (≥14). A positive change form baseline represents an increase in symptoms.	Baseline and Day 169
Population 2: Change From Baseline in ESSPRI at Day 169	The ESSPRI is a self-assessment tool for evaluating symptoms of dryness, fatigue, and pain (articular and/or muscular) in SS. Participants rate each of the three domains on a 0-10 numerical scale (0 = no; 10 maximal imaginable severity). All domains are equally weighted, and the total score is the mean of the three domain scores. The maximum total score for the ESSPRI assessment is 10. A positive change form baseline represents an increase in symptoms.	Baseline and Day 169

Secondary Outcomes

Measure	Description	Time Frame
Population 1: Change From Baseline in ESSPRI at Day 169	The ESSPRI is a self-assessment tool for evaluating symptoms of dryness, fatigue, and pain (articular and/or muscular) in SS. Participants rate each of the three domains on a 0-10 numerical scale (0 = no; 10 maximal imaginable severity). All domains are equally weighted, and the total score is the mean of the three domain scores. The maximum total score for the ESSPRI assessment is 10. A positive change from baseline represents an increase in symptoms.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with SS by meeting the 2016 American College of Rheumatology (ACR)/EULAR Classification Criteria.
Residual salivary gland function as defined by whole stimulated salivary flow > 0.1 mL/min (only for Population 2).
Have an ESSDAI score of >= 5 at screening; (not including the peripheral nervous system, central nervous system, and pulmonary domains) (only for Population 1).
Have an ESSPRI score of >= 5 at screening (only for Population 2).
Have an ESSDAI score of < 5 at screening (only for Population 2).
Positive for either anti-Ro autoantibodies or rheumatoid factor, or both at screening.
Male and female participants who agree to follow protocol defined contraceptive methods.
No active or untreated latent tuberculosis (TB).

Exclusion Criteria:

Medical history of confirmed deep venous thrombosis or arterial thromboembolism within 2 years of signing the informed consent form (ICF).
Risk factors for venous thromboembolism or arterial thrombosis, prothrombotic status.
Concomitant polymyositis or dermatomyositis or systemic sclerosis.
Active malignancy or history of malignancy, except in situ carcinoma of the cervix and cutaneous basal cell carcinoma.
Hepatitis B, hepatitis C, or human immunodeficiency virus infection.
More than one episode of herpes zoster and/or an opportunistic infection in the last 12 months.
Active viral, bacterial, or other infections or history of more than 2 infections requiring intravenous antibiotics within 12 months prior to signing the ICF.
Participants with corona virus disease 2019 (COVID-19) infection or who, in the judgment of the investigator, are at unacceptable risk of COVID-19 or its complications.
A documented positive severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) test within 2 weeks prior to randomization.
Received live (attenuated) vaccine within the 4 weeks prior to ICF signature.
Treated with any biologic B-cell-depleting therapy within 12 months or other B-cell targeting therapy < 3 months before randomization.
Injectable corticosteroids (including intraarticular) or treatment with > 10 mg/day dose oral prednisone or equivalent within 6 weeks prior to randomization (only for Population 1).
Treated with systemic corticosteroids for indications other than SS, rheumatoid arthritis (RA), and systemic lupus erythematosus (SLE) for more than a total of 2 weeks within 24 weeks prior to screening visit (only for Population 1).
Received previous treatment with anti-CD40L compounds at any time before screening.
Pregnant or lactating or planning to get pregnant during the duration of the study.

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Fullerton	California	92835	United States
Research site

PubMed Identifier	Type	Citation	Retractions
38839899	Background	St Clair EW, Baer AN, Ng WF, Noaiseh G, Baldini C, Tarrant TK, Papas A, Devauchelle-Pensec V, Wang L, Xu W, Pham TH, Sikora K, Rees WA, Alevizos I. CD40 ligand antagonist dazodalibep in Sjogren's disease: a randomized, double-blinded, placebo-controlled, phase 2 trial. Nat Med. 2024 Jun;30(6):1583-1592. doi: 10.1038/s41591-024-03009-3. Epub 2024 Jun 5.

Label	URL
AmgenTrials clinical trials website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Population 1: Placebo/VIB4920	Participants with SS characterized by moderate to severe systemic disease activity (defined by an ESSDAI score of ≥ 5), were randomized to receive a placebo in Stage I, followed by VIB4920 in Stage II.
FG001	Population 1: VIB4920/Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 8, 2022	Apr 10, 2025

Arm/Group Information

ID	Title	Description
BG000	Population 1: Placebo/VIB4920	Participants with SS characterized by moderate to severe systemic disease activity (defined by an ESSDAI score of ≥ 5), were randomized to receive a placebo in Stage I, followed by VIB4920 in Stage II.
BG001	Population 1: VIB4920/Placebo	Participants with SS characterized by moderate to severe systemic disease activity (defined by a ESSDAI score of ≥ 5), were randomized to receive multiple doses of VIB4920 in Stage I, followed by a placebo in Stage II.
BG002	Population 2: Placebo/VIB4920	Participants with SS characterized by moderate to severe subjective symptoms (defined by an ESSPRI score of ≥ 5), and low systemic disease activity (ESSDAI score < 5), were randomized to receive a placebo in Stage I, followed by VIB4920 in Stage II.
BG003	Population 2: VIB4920/Placebo	Participants with SS, characterized by moderate to severe subjective symptoms (defined by an ESSPRI score of ≥ 5), and low systemic disease activity (ESSDAI score < 5), were randomized to receive multiple doses of VIB4920 in Stage I, followed by a placebo in Stage II.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title	Denominators	Categories
18-85 years	ParticipantsBG00038 ParticipantsBG00136 ParticipantsBG00255 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00038 ParticipantsBG00136 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00038 ParticipantsBG00136 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
American Indian or Alaska Native	ParticipantsBG00038 ParticipantsBG00136 ParticipantsBG002

Population 1: Baseline ESSDAI Total Score

The baseline ESSDAI total score for Population 1 is reported to support the primary outcome measure and is not collected for the overall study population.

Mean

Standard Deviation

score on scale

Title	Denominators	Categories
	ParticipantsBG00038 ParticipantsBG001

Population 2: Baseline ESSPRI Total Score

The baseline ESSPRI total score for Population 2 is reported to support the primary outcome measure and is not collected for the overall study population, including Population 1.

Mean

Standard Deviation

score on a scale

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG001

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

Population 1: Change From Baseline in ESSDAI at Day 169

The ESSDAI is a systemic disease activity index for SS, assessing 12 domains (Constitutional, Salivary Glands, Lungs, Kidneys, Musculoskeletal, Peripheral Nervous System, Central Nervous System, Vascular, Gastrointestinal, Hematological, Ocular, and Extraglandular Manifestations). Each domain is graded for activity (0 = no activity to 3 = high activity) and weighted (1 for Biological to 6 for Muscular) based on its clinical significance, with the final score calculated as the sum of all weighted domain scores. The theoretical range is 0 to 123, with disease activity categorized as low (<5), moderate (5-13), and high (≥14). A positive change form baseline represents an increase in symptoms.

FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.

Posted

Least Squares Mean

Standard Error

Score on scale

Baseline and Day 169

ID	Title	Description
OG000	Population 1: Placebo	Participants with SS characterized by moderate to severe systemic disease activity (defined by an ESSDAI score of ≥ 5), were randomized to receive a placebo in Stage I.
OG001	Population 1: VIB4920	Participants with SS characterized by moderate to severe systemic disease activity (defined by a ESSDAI score of ≥ 5), were randomized to receive multiple doses of VIB4920 in Stage I.

Units	Counts
Participants	OG00036 OG00133

Title

Denominators

Categories

Title	Measurements
	OG000-4.1± 0.6 OG001-6.3± 0.6

Primary

Population 2: Change From Baseline in ESSPRI at Day 169

FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.

Posted

Least Squares Mean

Standard Error

Score on scale

Baseline and Day 169

ID	Title	Description
OG000	Population 2: Placebo	Participants with SS characterized by moderate to severe subjective symptoms (defined by an ESSPRI score of ≥ 5), and low systemic disease activity (ESSDAI score < 5), were randomized to receive a placebo in Stage I.
OG001	Population 2: VIB4920	Participants with SS, characterized by moderate to severe subjective symptoms (defined by an ESSPRI score of ≥ 5), and low systemic disease activity (ESSDAI score < 5), were randomized to receive multiple doses of VIB4920 in Stage I.

Secondary

Population 1: Change From Baseline in ESSPRI at Day 169

FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.

Posted

Least Squares Mean

Standard Error

Score on scale

Baseline and Day 169

ID	Title	Description
OG000	Population 1: Placebo	Participants with SS characterized by moderate to severe systemic disease activity (defined by an ESSDAI score of ≥ 5), were randomized to receive a placebo in Stage I.
OG001	Population 1: VIB4920	Participants with SS characterized by moderate to severe systemic disease activity (defined by a ESSDAI score of ≥ 5), were randomized to receive multiple doses of VIB4920 in Stage I.

Secondary

Population 1: Number of Participants Who Achieved ESSDAI[3] and ESSDAI[4] Response at Day 169

The ESSDAI is a systemic disease activity index for primary Sjögren's syndrome, assessing 12 domains (e.g., cutaneous, renal, CNS, and biological). Each domain is graded for activity (0 = no activity to 3 = high activity) and weighted (1 for Biological to 6 for Muscular) based on its clinical significance, with the final score calculated as the sum of all weighted domain scores. The theoretical range is 0 to 123, with disease activity categorized as low (<5), moderate (5-13), and high (≥14). A positive change from baseline represents an increase in symptoms.

ESSEDAI[3] and [4] responses were defined as a decrease of at least 3 or 4 points respectively in the ESSDAI score from the baseline value, measured at Day 169.

FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.

Posted

Count of Participants

Participants

Day 169

ID	Title	Description
OG000	Population 1: Placebo	Participants with SS characterized by moderate to severe systemic disease activity (defined by an ESSDAI score of ≥ 5), were randomized to receive a placebo in Stage I.
OG001	Population 1: VIB4920	Participants with SS characterized by moderate to severe systemic disease activity (defined by a ESSDAI score of ≥ 5), were randomized to receive multiple doses of VIB4920 in Stage I.

Secondary

Change From Baseline in The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Day 169

The FACIT-Fatigue is a 13-item patient-reported questionnaire designed to assess the impact of fatigue on quality of life (QoL). Responses are scored from 0 (Not at all) to 4 (Very Much). The total score is the sum of all responses, ranging from 0 to 52, with higher scores indicating better QoL. A positive change from baseline represents an increase in QoL.

FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.

Posted

Least Squares Mean

Standard Error

Score on scale

Baseline and Day 169

ID	Title	Description
OG000	Population 1: Placebo	Participants with SS characterized by moderate to severe systemic disease activity (defined by an ESSDAI score of ≥ 5), were randomized to receive a placebo in Stage I.
OG001	Population 1: VIB4920	Participants with SS characterized by moderate to severe systemic disease activity (defined by a ESSDAI score of ≥ 5), were randomized to receive multiple doses of VIB4920 in Stage I.
OG002	Population 2: Placebo

Secondary

Change From Baseline in Ocular Surface Disease Index (OSDI) at Day 169

The OSDI is a validated tool for assessing vision-related function and dry eye disease severity (normal, mild, moderate, severe). It consists of 12 questions, with responses ranging from 0 (None of the time) to 4 (All of the time). Scores range from 0 to 100, as it is calculated by transforming the raw responses from the 12 questions into a standardized 0-100 scale, with higher scores indicating greater disability. A positive change from baseline indicates a worsening vision-related function.

FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.

Posted

Least Squares Mean

Standard Error

Score on scale

Baseline and Day 169

ID	Title	Description
OG000	Population 1: Placebo	Participants with SS characterized by moderate to severe systemic disease activity (defined by an ESSDAI score of ≥ 5), were randomized to receive a placebo in Stage I.
OG001	Population 1: VIB4920	Participants with SS characterized by moderate to severe systemic disease activity (defined by a ESSDAI score of ≥ 5), were randomized to receive multiple doses of VIB4920 in Stage I.
OG002	Population 2: Placebo

Secondary

Patient Global Impression of Severity (PGIS) Score at Day 169

The PGIS is a single-item measure that captures a patient's perception of overall symptom severity over the past week, using a 5-point categorical response scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe), with higher scores indicating greater symptom severity. Positive change from baseline values indicate worsening of symptoms severity.

FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.

Posted

Least Squares Mean

Standard Error

Score on scale

Baseline and Day 169

ID	Title	Description
OG000	Population 1: Placebo	Participants with SS characterized by moderate to severe systemic disease activity (defined by an ESSDAI score of ≥ 5), were randomized to receive a placebo in Stage I.
OG001	Population 1: VIB4920	Participants with SS characterized by moderate to severe systemic disease activity (defined by a ESSDAI score of ≥ 5), were randomized to receive multiple doses of VIB4920 in Stage I.
OG002	Population 2: Placebo	Participants with SS characterized by moderate to severe subjective symptoms (defined by an ESSPRI score of ≥ 5), and low systemic disease activity (ESSDAI score < 5), were randomized to receive a placebo in Stage I.

Secondary

Population 2: Number of Participants Who Achieved ESSPRI Response at Day 169

The ESSPRI is a self-assessment tool for evaluating symptoms of dryness, fatigue, and pain (articular and/or muscular) in SS. Participants rate each of the three domains on a 0-10 numerical scale (0 = no; 10 maximal imaginable severity). All domains are equally weighted, and the total score is the mean of the three domain scores. The maximum total score for the ESSPRI assessment is 10. A positive change form baseline represents an increase in symptoms. Participants achieving an ESSPRI response were defined as at least a 1 point or 15% reduction from baseline in ESSPRI score at Day 169 without premature discontinuation from the study and without receiving rescue medications.

FAS: included all randomized participants who received any dose of investigational product, analyzed according to the randomized treatment, and had available data at the specified time points.

Posted

Count of Participants

Participants

Day 169

ID	Title	Description
OG000	Population 2: Placebo	Participants with SS characterized by moderate to severe subjective symptoms (defined by an ESSPRI score of ≥ 5), and low systemic disease activity (ESSDAI score < 5), were randomized to receive a placebo in Stage I.
OG001	Population 2: VIB4920	Participants with SS, characterized by moderate to severe subjective symptoms (defined by an ESSPRI score of ≥ 5), and low systemic disease activity (ESSDAI score < 5), were randomized to receive multiple doses of VIB4920 in Stage I.

Secondary

Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) referred to any untoward medical occurrence in a clinical study participant, regardless of a causal relationship with the study treatment. TEAEs included any event occurring after the participant received the study treatment. Clinically significant changes in vital signs, electrocardiograms, and laboratory tests recorded after treatment administration were documented as TEAEs. Serious TEAEs (SAEs) were untoward medical occurrences after the first dose, irrespective of a causal link to the study treatment, that led to death, were life-threatening, required hospitalization or its prolongation, caused significant disability, resulted in congenital anomalies, or were considered other medically important events. AEs were graded (Grade 3: severe; Grade 4: life-threatening; Grade 5: death) using the Common Terminology Criteria for Adverse Events (CTCAE).

Safety Analysis Set: included all participants who received any dose of investigational product.

Posted

Count of Participants

Participants

Up to approximately 365 days

ID	Title	Description
OG000	Population 1: Placebo/VIB4920	Participants with SS characterized by moderate to severe systemic disease activity (defined by an ESSDAI score of ≥ 5), were randomized to receive a placebo in Stage I, followed by VIB4920 in Stage II.
OG001	Population 1: VIB4920/Placebo	Participants with SS characterized by moderate to severe systemic disease activity (defined by a ESSDAI score of ≥ 5), were randomized to receive multiple doses of VIB4920 in Stage I, followed by a placebo in Stage II.

Secondary

Serum Concentration of VIB4920

Blood samples were collected at the specified time points.

Pharmacokinetic (PK) Analysis Set: included all participants who received investigational product and had at least one quantifiable plasma PK observation post-first dose.

Posted

Mean

Standard Deviation

mg/L

Day 1 pre-dose, Day 1 post-dose, Day 15, Day 29, Day 57, Day 85, Day 113, Day 141 pre-dose, Day 141 post-dose, Day 169 pre-dose, Day 169 post-dose, Day 197, Day 225, Day 253, Day 281, Day 309, Day 365

ID	Title	Description
OG000	Population 1: Placebo/VIB4920	Participants with SS characterized by moderate to severe systemic disease activity (defined by an ESSDAI score of ≥ 5), were randomized to receive a placebo in Stage I, followed by VIB4920 in Stage II.
OG001	Population 1: VIB4920/Placebo	Participants with SS characterized by moderate to severe systemic disease activity (defined by a ESSDAI score of ≥ 5), were randomized to receive multiple doses of VIB4920 in Stage I, followed by a placebo in Stage II.
OG002	Population 2: Placebo/VIB4920	Participants with SS characterized by moderate to severe subjective symptoms (defined by an ESSPRI score of ≥ 5), and low systemic disease activity (ESSDAI score < 5), were randomized to receive a placebo in Stage I, followed by VIB4920 in Stage II.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Population 1: Placebo (Stage I)	Participants with SS characterized by moderate to severe systemic disease activity (defined by an ESSDAI score of ≥ 5), were randomized to receive a placebo in Stage I.	0	38	0	38	18	38
EG001	Population 1: VIB4920 (Stage I)	Participants with SS characterized by moderate to severe systemic disease activity (defined by a ESSDAI score of ≥ 5), were randomized to receive multiple doses of VIB4920 in Stage I.	1	36	1	36	20	36
EG002	Population 1: VIB4920 (Stage II)	Participants with SS characterized by moderate to severe systemic disease activity (defined by an ESSDAI score of ≥ 5), who received VIB4920 in Stage II.	0	37	1	37	24	37
EG003	Population 1: Placebo (Stage II)	Participants with SS characterized by moderate to severe systemic disease activity (defined by an ESSDAI score of ≥ 5), who received placebo in Stage II.	0	34	3	34	22	34
EG004	Population 2: Placebo (Stage I)	Participants with SS characterized by moderate to severe subjective symptoms (defined by an ESSPRI score of ≥ 5), and low systemic disease activity (ESSDAI score < 5), were randomized to receive a placebo in Stage I.	0	55	1	55	21	55
EG005	Population 2: VIB4920 (Stage I)	Participants with SS, characterized by moderate to severe subjective symptoms (defined by an ESSPRI score of ≥ 5), and low systemic disease activity (ESSDAI score < 5), were randomized to receive multiple doses of VIB4920 in Stage I.	0	54	3	54	21	54
EG006	Population 2: VIB4920 (Stage II)	Participants with SS characterized by moderate to severe subjective symptoms (defined by an ESSPRI score of ≥ 5), and low systemic disease activity (ESSDAI score < 5), who received VIB4920 in Stage II.	0	52	1	52	20	52
EG007	Population 2: Placebo (Stage II)	Participants with SS characterized by moderate to severe subjective symptoms (defined by an ESSPRI score of ≥ 5), and low systemic disease activity (ESSDAI score < 5), who received placebo in Stage II.	0	49	2	49	21	49

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG0030 affected34 at risk EG0041 affected55 at risk EG0050 affected54 at risk EG0060 affected52 at risk EG0070 affected49 at risk
Atrial flutter	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Death	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0011 affected36 at risk EG0020 affected37 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0021 affected37 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0011 affected36 at risk EG0020 affected37 at risk EG003
Pneumonia influenzal	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Post-acute COVID-19 syndrome	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Cervical dysplasia	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected38 at risk EG0010 affected36 at risk EG0021 affected37 at risk EG0030 affected34 at risk EG0042 affected55 at risk EG0054 affected54 at risk EG0060 affected52 at risk EG0071 affected49 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0011 affected36 at risk EG0020 affected37 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0013 affected36 at risk EG0022 affected37 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0011 affected36 at risk EG0020 affected37 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0003 affected38 at risk EG0012 affected36 at risk EG0021 affected37 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected38 at risk EG0011 affected36 at risk EG0022 affected37 at risk EG003
Fatigue	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected38 at risk EG0012 affected36 at risk EG0021 affected37 at risk EG003
Device allergy	Immune system disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0012 affected36 at risk EG0020 affected37 at risk EG003
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0014 affected36 at risk EG0026 affected37 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected38 at risk EG0010 affected36 at risk EG0021 affected37 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0011 affected36 at risk EG0023 affected37 at risk EG003
Oral herpes	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected38 at risk EG0010 affected36 at risk EG0023 affected37 at risk EG003
Rhinitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Sinusitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0022 affected37 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 affected38 at risk EG0013 affected36 at risk EG0025 affected37 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 affected38 at risk EG0010 affected36 at risk EG0022 affected37 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0012 affected36 at risk EG0020 affected37 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0013 affected36 at risk EG0020 affected37 at risk EG003
Blood creatinine increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 affected38 at risk EG0011 affected36 at risk EG0020 affected37 at risk EG003
Blood pressure increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0002 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected38 at risk EG0010 affected36 at risk EG0023 affected37 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0002 affected38 at risk EG0010 affected36 at risk EG0021 affected37 at risk EG003
Dizziness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected38 at risk EG0013 affected36 at risk EG0021 affected37 at risk EG003
Headache	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0005 affected38 at risk EG0014 affected36 at risk EG0024 affected37 at risk EG003
Syncope	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected38 at risk EG0010 affected36 at risk EG0023 affected37 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0012 affected36 at risk EG0020 affected37 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 affected38 at risk EG0010 affected36 at risk EG0020 affected37 at risk EG003
Hypertension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 affected38 at risk EG0012 affected36 at risk EG0021 affected37 at risk EG003

ID	Term
D001172	Arthritis, Rheumatoid
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D014987	Xerostomia
D012466	Salivary Gland Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D015352	Dry Eye Syndromes
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases