Study to Assess the Efficacy and Safety of Nemolizumab (C... | NCT04501666

ID	Type	Description	Link
2019-004293-25	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nemolizumab	Experimental	Participants weighing less than (<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once every 4 weeks (Q4W). Participants weighing greater than or equal to (>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks.	Drug: Nemolizumab 30 mg
Placebo	Placebo Comparator	Participants weighing < 90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >= 90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Nemolizumab 30 mg	Drug	Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	Nemolizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16	The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as the average of 7 consecutive days of data up to the target study day (excluding) and set to missing if less than 4 days of data are available. Analysis window extension was applied to both timepoints, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.	Baseline, Week 16
Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16	IGA success is defined as clear (0) or almost clear (1), and a reduction from baseline of greater than or equal to 2 points at week 16. Full scale is scored from 0-4, higher score indicates more severe symptoms. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.	Baseline, Week 16

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)	AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs occurring after the first administration of the study drug until the last study visit. SAE was any untoward medical occurrence, in the view of either the Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. AESI was a noteworthy TEAE for the study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. Analysis was performed on safety population which included all randomised participants who received at least 1 administration of study drug.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of PN for at least 6 months with: Pruriginous nodular lesions on upper limbs, trunk, and/or lower limbs, at least 20 nodules on the entire body with a bilateral distribution and Investigator Global Assessment (IGA) score more than equal to (>=) 3 (based on the IGA scale ranging from 0 to 4, in which 3 was moderate and 4 is severe) at both the screening and baseline visits.
Severe pruritus was defined as follows on the PP NRS:
1. At the screening visit (Visit 1): PP NRS score was >= 7.0 for the 24-hour period immediately preceding the screening visit.
2. At the baseline visit (Visit 2): Mean of the daily intensity of the PP NRS score was >= 7.0 over the previous week.
Female participants of childbearing potential (that is [i.e,], fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree to use at least 1 adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
Participant was willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol, including daily diary recordings by the participant using an electronic handheld device provided for this study.

Exclusion Criteria:

Body weight less than < 30 kg.
Chronic pruritus resulting from another active condition other than PN, such as but not limited to scabies, lichen simplex chronicus, psoriasis, atopic dermatitis, contact dermatitis, acne, folliculitis, lichen planus, habitual picking/excoriation disorder, sporotrichosis, bullous autoimmune disease, end-stage renal disease, or cholestatic liver disease (example [e.g.] primary biliary cirrhosis) or diabetes mellitus or thyroid disease that is not adequately treated, as per standard of care.
Unilateral lesions of prurigo (e.g., only one arm affected).
History of or current confounding skin condition (e.g., Netherton syndrome, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], chronic actinic dermatitis, dermatitis herpetiformis).
Participants with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
Neuropathic and psychogenic pruritus such as but not limited to notalgia paresthetica, brachioradial pruritus, small fiber neuropathy, skin picking syndrome, or delusional parasitosis.
Requiring rescue therapy for PN during the screening period or expected to require rescue therapy within 4 weeks following the baseline visit.
Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C (HCV) antibody with positive confirmatory test for HCV (e.g., polymerase chain reaction [PCR]), or human immunodeficiency virus antibody) at the screening visit.

Facility	Status	City	State	ZIP	Country	Contacts
Galderma Investigational Site		Birmingham	Alabama	35233	United States
Galderma Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37888917	Result	Kwatra SG, Yosipovitch G, Legat FJ, Reich A, Paul C, Simon D, Naldi L, Lynde C, De Bruin-Weller MS, Nahm WK, Sauder M, Gharib R, Barbarot S, Szepietowski JC, Conrad C, Fleischer A, Laquer VT, Misery L, Serra-Baldrich E, Lapeere H, Ahmad F, Jabbar Lopez ZK, Piketty C, Stander S; OLYMPIA 2 Investigators. Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis. N Engl J Med. 2023 Oct 26;389(17):1579-1589. doi: 10.1056/NEJMoa2301333.
40266487

Label	URL
Description Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nemolizumab	Participants weighing less than (<) 90 kilogram (kg) received two subcutaneous (SC) injections of 30 milligrams (mg) nemolizumab (60 mg loading dose) at baseline then one SC injection once for every 4 weeks (Q4W). Participants weighing greater than or equal to (>=) 90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.

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 19, 2021	Jun 26, 2024

Arm/Group Information

ID	Title	Description
BG000	Nemolizumab	Participants weighing <90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.
BG001	Placebo	Participants weighing <90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.
BG002	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

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00057.5± 12.77 BG00157.6± 13.36 BG00257.5± 12.95

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000110 BG00156 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0004 BG0015 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0001 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Europe

Title	Measurements
	BG000141 BG00171 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 With an Improvement of Greater Than or Equal to (>=) 4 From Baseline in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16

The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as the average of 7 consecutive days of data up to the target study day (excluding) and set to missing if less than 4 days of data are available. Analysis window extension was applied to both timepoints, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.

ITT population included all randomized participants.

Posted

Count of Participants

Participants

Baseline, Week 16

ID	Title	Description
OG000	Nemolizumab	Participants weighing <90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.
OG001	Placebo	Participants weighing <90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.

Units	Counts
Participants	OG000190 OG00196

Title

Denominators

Categories

Title	Measurements
	OG000111 OG00116

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	A hierarchical testing procedure was used to control the overall type I error. Testing was then performed sequentially in order the outcome measures were reported and continued when previous outcome measure was statistically significant at two-sided 0.05.	Cochran-Mantel-Haenszel		< 0.0001	A 2-sided p-value was derived from Cochran-Mantel-Haenszel (CMH) test using the randomized stratification variables (analysis center and body weight at randomization [< 90 kg, >= 90 kg]). Threshold of significance at 0.05.	Strata adjusted percentage difference	40.1			2-Sided	95	29.4	50.8					Superiority

Primary

Number of Participants With an Investigator Global Assessment (IGA) Success at Week 16

IGA success is defined as clear (0) or almost clear (1), and a reduction from baseline of greater than or equal to 2 points at week 16. Full scale is scored from 0-4, higher score indicates more severe symptoms. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.

ITT population included all randomized participants.

Posted

Count of Participants

Participants

Baseline, Week 16

ID	Title	Description
OG000	Nemolizumab	Participants weighing <90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.
OG001	Placebo	Participants weighing <90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)

AE was defined as any untoward medical occurrence in a clinical study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs occurring after the first administration of the study drug until the last study visit. SAE was any untoward medical occurrence, in the view of either the Investigator or Sponsor, that resulted in death, was life-threatening, resulted in inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. AESI was a noteworthy TEAE for the study drug that was to be monitored closely and reported promptly. Relatedness to study drug was based on Investigator's discretion. Analysis was performed on safety population which included all randomised participants who received at least 1 administration of study drug.

Safety population included all randomized participants who received at least 1 administration of study drug.

Posted

Count of Participants

Participants

From Baseline up to end of treatment period (24 weeks)

ID	Title	Description
OG000	Nemolizumab	Participants weighing <90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.

Secondary

Number of Participants With an Improvement of >= 4 From Baseline in Weekly Average PP NRS at Week 4

The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to baseline, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.

ITT population included all randomized participants.

Posted

Count of Participants

Participants

Baseline, Week 4

ID	Title	Description
OG000	Nemolizumab	Participants weighing <90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.
OG001	Placebo

Secondary

Number of Participants With PP NRS < 2 at Week 16

The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to week 16, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.

ITT population included all randomized participants.

Posted

Count of Participants

Participants

Week 16

ID	Title	Description
OG000	Nemolizumab	Participants weighing <90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.
OG001	Placebo

Secondary

Number of Participants With an Improvement of >=4 From Baseline in Sleep Disturbance Numeric Rating Scale (SD NRS) at Week 16

The SD NRS is a scale to report the degree of participant sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to 10) during the 7 days up to the treatment start (including until treatment start time). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to both timepoints, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.

ITT population included all randomized participants.

Posted

Count of Participants

Participants

Baseline, Week 16

ID	Title	Description
OG000	Nemolizumab	Participants weighing <90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.

Secondary

Number of Participants With an Improvement of >=4 From Baseline in SD NRS at Week 4

SD NRS is a scale to be used by the participants to report the degree of their sleep loss related to PN. The baseline SD NRS was determined based on the average of daily SD NRS (score ranging from 0 to10) during the 7 days up to the treatment start (including until treatment start time). A minimum of 4 daily scores out of the 7 days up to baseline study day is required for this calculation. On a scale of 0 to 10, with 0 being 'no sleep loss related to the symptoms of my skin disease (prurigo nodularis)' and 10 being 'I did not sleep at all due to the symptoms of prurigo nodularis'. Higher scores indicate worse outcome. Analysis window extension was applied to baseline, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responde

ITT population included all randomized participants.

Posted

Count of Participants

Participants

Baseline, Week 4

ID	Title	Description
OG000	Nemolizumab	Participants weighing <90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.

Secondary

Number of Participants With PP NRS < 2 at Week 4

The Peak Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome. Weekly values are calculated as average of 7 consecutive days data up to the target study day (excluding) and set to missing, if less than 4 days data are available. Analysis window extension was applied to baseline, as described in the SAP. If a participant received any rescue therapy, composite variable strategy is applied, the underlying data at/after receipt of rescue therapy is set as worst possible value, and the response is derived from underlying data value. Participants with missing results are considered as non-responders.

ITT population included all randomized participants.

Posted

Count of Participants

Participants

Week 4

ID	Title	Description
OG000	Nemolizumab	Participants weighing <90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.
OG001	Placebo

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	Nemolizumab	Participants weighing <90 kg received two SC injections of 30 mg nemolizumab (60 mg loading dose) at baseline then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of 30 mg nemolizumab (60 mg total) at baseline (no loading dose) and two SC injections Q4W throughout the treatment period of 16 weeks. Nemolizumab: Participants received either 30 mg or 60 mg dose of nemolizumab as SC injection.	0	187	16	187	61	187
EG001	Placebo	Participants weighing <90 kg received two SC injections of matching placebo at baseline, then one SC injection Q4W. Participants weighing >=90 kg received two SC injections of matching placebo at baseline, then two SC injections Q4W throughout the treatment period of 16 weeks. Placebo: Participants received matching placebo as SC injection.	1	95	10	95	38	95

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
Oedema peripheral	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected187 at risk EG0011 events1 affected95 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected187 at risk EG0011 events1 affected95 at risk
Depressed mood	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
Panic disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected187 at risk EG0011 events1 affected95 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected187 at risk EG0011 events1 affected95 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
Coronary artery disease	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
Cardiac sarcoidosis	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected187 at risk EG0011 events1 affected95 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected187 at risk EG0011 events1 affected95 at risk
Arachnoid cyst	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
Tension headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected187 at risk EG0012 events2 affected95 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
Acarodermatitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
Campylobacter colitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
Cellulitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0011 events1 affected95 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected187 at risk EG0011 events1 affected95 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected187 at risk EG0010 events0 affected95 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG00016 events13 affected187 at risk EG0012 events2 affected95 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG00011 events9 affected187 at risk EG0016 events5 affected95 at risk
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG00017 events15 affected187 at risk EG00121 events18 affected95 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG00010 events10 affected187 at risk EG0011 events1 affected95 at risk
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG00014 events14 affected187 at risk EG00114 events14 affected95 at risk
Nasopharyngitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG00012 events11 affected187 at risk EG0018 events8 affected95 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG00012 events6 affected187 at risk EG0015 events5 affected95 at risk

ID	Term
D017437	Skin and Connective Tissue Diseases
D003872	Dermatitis
D017443	Skin Diseases, Eczematous
D012877	Skin Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011536	Prurigo
D009450	Neurodermatitis
D011537	Pruritus
D012871	Skin Diseases