Study of Posoleucel (Formerly Known as ALVR105; Viralym-M... | NCT04605484

NCT04605484

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Posoleucel	Experimental	Arm 1: Regimen A	Biological: Posoleucel (formerly known as ALVR105) cells
Posoleucel and Placebo	Experimental	Arm 2: Regimen B	Biological: Posoleucel (formerly known as ALVR105) cells Biological: Placebo (visually identical to Posoleucel)
Placebo	Placebo Comparator	Arm 3: Regimen A	Biological: Placebo (visually identical to Posoleucel)

Name	Type	Description	Arm Group Labels	Other Names
Posoleucel (formerly known as ALVR105) cells	Biological	Infusion	Posoleucel Posoleucel and Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)	An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs are defined as AEs with a start date and time on or after the first dose of study treatment through the end of study. Clinically significant changes in vital signs, physical exams, laboratory assessments and electrocardiograms were also reported as TEAEs.	Day 1 to Week 24

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in BK Viral Load	BK viral load was quantitated using polymerase chain reaction assays at the central laboratory. A negative change from baseline represents a reduction in BK viral load.	Baseline and Week 24

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Keck Medical Center of USC		Los Angeles	California	90033	United States
Stanford University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28783452	Background	Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.
38470444

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Posoleucel (PSL) Group 1	Participants received PSL at a dose of 4 × 10^7 cells as a slow push intravenous (IV) infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of PSL). Participants continued to be observed for a 12-week follow-up.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 30, 2021	Apr 23, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Intent-to-Treat (ITT) Population: Included all randomized participants.

Arm/Group Information

ID	Title	Description
BG000	PSL Group 1	Participants received PSL at a dose of 4 × 10^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of PSL). Participants continued to be observed for a 12-week follow-up.
BG001	PSL Group 2	Participants received PSL at a dose of 4 × 10^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 28 days during the 12-week dosing period (5 total doses of PSL). Participants continued to be observed for a 12-week follow-up.
BG002	Placebo	Participants received placebo matching PSL as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of placebo). Participants continued to be observed for a 12-week follow-up.
BG003	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, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00059.0(21 to 75) BG00154.0(28 to 72) BG00259.0(47 to 75) BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0003 BG0015 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG0015 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Asian	BG0001 BG0013 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00020 BG00122 BG002

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

Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)

An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs are defined as AEs with a start date and time on or after the first dose of study treatment through the end of study.

Clinically significant changes in vital signs, physical exams, laboratory assessments and electrocardiograms were also reported as TEAEs.

Safety Population: Included all participants who received any amount of PSL or placebo.

Posted

Count of Participants

Participants

Day 1 to Week 24

ID	Title	Description
OG000	PSL Group 1	Participants received PSL at a dose of 4 × 10^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of PSL). Participants continued to be observed for a 12-week follow-up.
OG001	PSL Group 2	Participants received PSL at a dose of 4 × 10^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 28 days during the 12-week dosing period (5 total doses of PSL). Participants continued to be observed for a 12-week follow-up.
OG002	Placebo	Participants received placebo matching PSL as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of placebo). Participants continued to be observed for a 12-week follow-up.

Units	Counts
Participants	OG00020 OG00122 OG00219

Title

Denominators

Categories

Title	Measurements
	OG00017 OG00117 OG00216

Secondary

Change From Baseline in BK Viral Load

BK viral load was quantitated using polymerase chain reaction assays at the central laboratory. A negative change from baseline represents a reduction in BK viral load.

ITT Population: Included all randomized participant with Week 24 BK viral load data available.

Posted

Median

Full Range

log10 copies/mL

Baseline and Week 24

ID	Title	Description
OG000	PSL Group 1	Participants received PSL at a dose of 4 × 10^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of PSL). Participants continued to be observed for a 12-week follow-up.
OG001	PSL Group 2	Participants received PSL at a dose of 4 × 10^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 28 days during the 12-week dosing period (5 total doses of PSL). Participants continued to be observed for a 12-week follow-up.
OG002	Placebo	Participants received placebo matching PSL as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of placebo). Participants continued to be observed for a 12-week follow-up.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PSL Group 1	Participants received PSL at a dose of 4 × 10^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	20	2	20	16	20
EG001	PSL Group 2	Participants received PSL at a dose of 4 × 10^7 cells as a slow push IV infusion once per week for 3 weeks, then once every 28 days during the 12-week dosing period (5 total doses of PSL). Participants continued to be observed for a 12-week follow-up.	22	2	22	16	22
EG002	Placebo	Participants received placebo matching PSL as a slow push IV infusion once per week for 3 weeks, then once every 14 days during the 12-week dosing period (8 total doses of placebo). Participants continued to be observed for a 12-week follow-up.	19	0	19	16	19

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Transplant rejection	Immune system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Enterococcal bacteraemia	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Pyelonephritis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Renal tuberculosis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Urosepsis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Proteinuria	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Tachycardia	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Conduction disorder	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Sinus bradycardia	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Diabetic retinopathy	Eye disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Uveitis	Eye disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0012 affected22 at risk EG0021 affected19 at risk
Nausea	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0022 affected19 at risk
Vomiting	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Oedema peripheral	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0022 affected19 at risk
Pyrexia	General disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0012 affected22 at risk EG0020 affected19 at risk
Chills	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected19 at risk
Fatigue	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected19 at risk
Pain	General disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Infusion site bruising	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Infusion site pain	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Injection site swelling	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Peripheral swelling	General disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Transplant rejection	Immune system disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
COVID-19	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0003 affected20 at risk EG0012 affected22 at risk EG0023 affected19 at risk
Epstein-Barr viraemia	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0002 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Polyomavirus viraemia	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0002 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Bronchitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected19 at risk
Nasopharyngitis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0022 affected19 at risk
Polyomavirus-associated nephropathy	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Influenza	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
JC virus infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Metapneumovirus infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Root canal infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Tinea pedis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Urosepsis	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Blood creatinine increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0003 affected20 at risk EG0011 affected22 at risk EG0021 affected19 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected19 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected19 at risk
Alanine aminotransferase increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Blood glucose increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Blood magnesium decreased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Blood pressure diastolic decreased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Blood uric acid increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Cystatin C increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Epstein-Barr virus test positive	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Glomerular filtration rate decreased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Haematocrit decreased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Haemoglobin decreased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Heart rate decreased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Immunosuppressant drug level increased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
JC polyomavirus test positive	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Platelet count decreased	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Urine leukocyte esterase positive	Investigations	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Gout	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Acidosis	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Limb mass	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Headache	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0014 affected22 at risk EG0024 affected19 at risk
Dizziness	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0021 affected19 at risk
Balance disorder	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Migraine	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Somnolence	Nervous system disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Euphoric mood	Psychiatric disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Dysuria	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Post micturition dribble	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Renal impairment	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Urethral disorder	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Rhinalgia	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0013 affected22 at risk EG0020 affected19 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Hair disorder	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Scab	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0010 affected22 at risk EG0021 affected19 at risk
Hypotension	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0002 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk
Flushing	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Hypertension	Vascular disorders	MedDRA (25.0)	Systematic Assessment	EG0000 affected20 at risk EG0011 affected22 at risk EG0020 affected19 at risk
Urinary tract infection	Infections and infestations	MedDRA (25.0)	Systematic Assessment	EG0001 affected20 at risk EG0010 affected22 at risk EG0020 affected19 at risk

ID	Term
D002452	Cell Count

Ancestor Terms

ID	Term
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques
D002468	Cell Physiological Phenomena