Study to Assess the Efficacy and Safety of Orismilast in... | NCT05190419

ID	Type	Description	Link
2021-003209-22	EudraCT Number

Label	Type	Description	Intervention Names
Orismilast modified release tablets 20 mg BID	Experimental	Oral, twice daily morning and evening for 16 weeks	Drug: Orismilast modified release tablets
Orismilast modified release tablets 30 mg BID	Experimental	Oral, twice daily morning and evening for 16 weeks	Drug: Orismilast modified release tablets
Orismilast modified release tablets 40 mg BID	Experimental	Oral, twice daily morning and evening for 16 weeks	Drug: Orismilast modified release tablets
Placebo tablets BID	Placebo Comparator	Oral, twice daily morning and evening for 16 weeks	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Orismilast modified release tablets	Drug	Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Measure	Description	Time Frame
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16	The Psoriasis Activity and Severity Index (PASI) is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI.	Baseline and Week 16

Measure	Description	Time Frame
Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16	The PASI is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI. PASI75 is 75% reduction from Baseline in PASI score.

Name	Affiliation	Role
P. A., MD	UNION therapeutics A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Central Connecticut Dermatology		Cromwell	Connecticut	06416	United States
GWU MFA

PubMed Identifier	Type	Citation	Retractions
40970551	Derived	Warren RB, Weiss A, Felding J, Sommer MOA, Garcet S, Krueger JG. Orismilast, a Potent and Selective PDE4B/D Inhibitor, Reduces Protein Levels of Key Disease Driving Cytokines in the Skin of Patients With Plaque Psoriasis. Exp Dermatol. 2025 Sep;34(9):e70153. doi: 10.1111/exd.70153.

ID	Title	Description
FG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
FG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation phosphodiesterase-4 (PDE4) inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 20, 2022	Nov 22, 2023

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

Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16

The Psoriasis Activity and Severity Index (PASI) is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI.

The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Week 16

ID	Title	Description
OG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
OG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
OG002	Orismilast Modified Release Tablets 30 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
OG003	Orismilast Modified Release Tablets 40 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Units	Counts
Participants	OG00051 OG00148 OG00250 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-17.30± 7.07 OG001-52.60± 6.80 OG002-61.20± 6.67 OG003

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		ANCOVA	p-value is calculated by analysis of covariance with treatment group as factor and baseline PASI as covariate.	<0.001	No adjustment for multiplicity was made and the 0.05 level of significance was used to claim efficacy compared with placebo.	Mean Difference (Net)	-35.4	Standard Error of the Mean	9.83	2-Sided	95	-54.7	-16.0					Superiority

Secondary

Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16

The PASI is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI. PASI75 is 75% reduction from Baseline in PASI score.

The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.

Posted

Number

percentage of participants

At Week 16

ID	Title	Description
OG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
OG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Secondary

Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Week 16

The IGA is a measure used by physicians to determine the patient's overall severity of disease. The static version is used in this trial for measurement at a single point in time as indicated in the schedule of assessments. The investigator will rate the severity of patient's psoriasis on a 5-point scale ranging from 0 (clear) to 4 (severe).

The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.

Posted

Number

percentage of participants

At Week 16

ID	Title	Description
OG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
OG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
OG002	Orismilast Modified Release Tablets 30 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Secondary

Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Weeks 4, 8, 12, and 20

The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.

Posted

Number

percentage of participants

At Weeks 4, 8, 12, and 20

ID	Title	Description
OG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
OG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
OG002	Orismilast Modified Release Tablets 30 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Secondary

Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20

The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.

Posted

Number

percentage of participants

At Weeks 4, 8, 12, and 20

ID	Title	Description
OG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
OG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Secondary

Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20

The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.

Posted

Count of Participants

Participants

At Weeks 4, 8, 12, 16, and 20

ID	Title	Description
OG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
OG001	Orismilast Modified Release Tablets 20 mg BID

Secondary

Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20

The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Weeks 4, 8, 12, and 20

ID	Title	Description
OG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
OG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Secondary

Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20

The DLQI is a 10-item validated questionnaire completed by the patient used to assess the impact of skin disease on the patient's quality of life (QoL) during the previous week. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, and treatment. Each question is scored from 0 to 3 ("not at all," "a little," "a lot," and "very much," respectively), giving a total score ranging from 0 to 30. A high score is indicative of a poor QoL.

The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug. "n" represents the number of participants analyzed at each time point in each treatment arm.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Weeks 16 and 20

ID	Title	Description
OG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
OG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
OG002

Secondary

Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20

The BSA assessment estimates the extent of disease or skin affected by psoriasis and is expressed as a percentage of total body surface. BSA was determined by the Investigator or designee using the patient palm = 1% BSA rule. The patient's palm is measured from the wrist to the proximal interphalangeal and thumb.

The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug. "n" represents the number of participants analyzed at each time point.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Weeks 4, 8, 12, 16, and 20

ID	Title	Description
OG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
OG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
OG002	Orismilast Modified Release Tablets 30 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Secondary

Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20

The PSS is a 4-item patient-completed questionnaire (Rentz 2017). It is patient relevant, its domains are reliable and valid, and it takes few minutes to complete. The PSS assesses severity of pain, itching, redness, and burning during the past 24 hours using a 5-point severity scale from 0 = none to 4 = very severe.

The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug. "n" represents the number of participants analyzed at each time point.

Posted

Mean

Standard Deviation

percent change

Baseline and Weeks 4, 8, 12, 16, and 20

ID	Title	Description
OG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
OG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
OG002	Orismilast Modified Release Tablets 30 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Secondary

Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20

The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug. "n" represents the number of participants analyzed at each time point.

Posted

Least Squares Mean

Standard Error

percent change

Baseline and Weeks 4, 8, 12, 16, and 20

ID	Title	Description
OG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
OG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
OG002	Orismilast Modified Release Tablets 30 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Secondary

Percentage of Participants Who Experienced Psoriasis Rebound by Week 20

The intent-to-treat (ITT) population included all randomized participants who received ≥1 dose of study drug.

Posted

Count of Participants

Participants

At Week 20

ID	Title	Description
OG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
OG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0002 events2 affected51 at risk EG00124 events18 affected48 at risk EG00235 events24 affected50 at risk EG00343 events24 affected53 at risk
Nausea	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0002 events2 affected51 at risk EG00112 events11 affected48 at risk EG00223 events19 affected50 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0023 events3 affected50 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0022 events1 affected50 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0014 events4 affected48 at risk EG0020 events0 affected50 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0023 events3 affected50 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0013 events3 affected48 at risk EG0026 events4 affected50 at risk EG003
Headache	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0006 events3 affected51 at risk EG0019 events6 affected48 at risk EG00216 events13 affected50 at risk EG003
Dizziness	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0013 events3 affected48 at risk EG0028 events7 affected50 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
COVID-19	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0003 events3 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0003 events3 affected51 at risk EG0011 events1 affected48 at risk EG0024 events4 affected50 at risk EG003
Fatigue	General disorders	MedDRA version 24.0	Systematic Assessment	EG0003 events1 affected51 at risk EG0011 events1 affected48 at risk EG0022 events2 affected50 at risk EG003
Asthenia	General disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0025 events3 affected50 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0004 events3 affected51 at risk EG0013 events3 affected48 at risk EG0021 events1 affected50 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0011 events1 affected48 at risk EG0021 events1 affected50 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0012 events2 affected48 at risk EG0021 events1 affected50 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0021 events1 affected50 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Hyperchlorhydria	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Mucous stools	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Trichoglossia	Gastrointestinal disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Sciatica	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Hypersomnia	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Lethargy	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Migraine	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Parosmia	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Post herpetic neuralgia	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Slow response to stimuli	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Somnolence	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0011 events1 affected48 at risk EG0022 events2 affected50 at risk EG003
Bronchitis	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0021 events1 affected50 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Cystitis	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0022 events2 affected50 at risk EG003
Abscess limb	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Body tinea	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Erythema migrans	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Gingivitis	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Herpes zoster	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Parotitis	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Pharyngitis	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Tonsillitis	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Tooth abscess	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Discomfort	General disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Malaise	General disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0021 events1 affected50 at risk EG003
Chills	General disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
General physical health deterioration	General disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Illness	General disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Oedema peripheral	General disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Peripheral swelling	General disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Pain	General disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Pyrexia	General disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Electrocardiogram abnormal	Investigations	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0012 events1 affected48 at risk EG0022 events1 affected50 at risk EG003
Weight decreased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
C-reactive protein increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Crystal urine present	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Haematocrit increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Mean cell haemoglobin concentration decreased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Mean cell volume increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Bacterial test positive	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Blood bilirubin increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Blood cholesterol increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Blood triglycerides increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Gamma-glutamyltransferase increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Liver function test increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Neutrophil count abnormal	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Protein urine present	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Transaminases increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Urinary sediment present	Investigations	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Blood glucose increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
High density lipoprotein decreased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Inflammatory marker increased	Investigations	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
QRS axis abnormal	Investigations	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Ultrasound abdomen abnormal	Investigations	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0022 events1 affected50 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0011 events1 affected48 at risk EG0022 events1 affected50 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0022 events2 affected50 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0002 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Hot flush	Vascular disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0012 events2 affected48 at risk EG0021 events1 affected50 at risk EG003
Hypertension	Vascular disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0021 events1 affected50 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0013 events2 affected48 at risk EG0021 events1 affected50 at risk EG003
Bundle branch block right	Cardiac disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Left ventricular hypertrophy	Cardiac disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Depression	Psychiatric disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Depressive symptom	Psychiatric disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Insomnia	Psychiatric disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Middle insomnia	Psychiatric disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Restlessness	Psychiatric disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Wisdom teeth removal	Surgical and medical procedures	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
White blood cell disorder	Blood and lymphatic system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA version 24.0	Systematic Assessment	EG0001 events1 affected51 at risk EG0010 events0 affected48 at risk EG0020 events0 affected50 at risk EG003

ID	Term
D017444	Skin Diseases, Papulosquamous
D017437	Skin and Connective Tissue Diseases

ID	Title	Description
BG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets
BG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
BG002	Orismilast Modified Release Tablets 30 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
BG003	Orismilast Modified Release Tablets 40 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo Tablets BID	Oral, twice daily morning and evening for 16 weeks Placebo: Matching placebo tablets	51	0	51	23	51
EG001	Orismilast Modified Release Tablets 20 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.	48	1	48	37	48
EG002	Orismilast Modified Release Tablets 30 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.	50	1	50	42	50
EG003	Orismilast Modified Release Tablets 40 mg BID	Oral, twice daily morning and evening for 16 weeks Orismilast modified release tablets: Orismilast modified release is a next generation PDE4 inhibitor with high selectivity for the PDE4 subtypes linked to inflammation.	53	0	53	50	53

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myocardial Infarction	Cardiac disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0011 events1 affected48 at risk EG0020 events0 affected50 at risk EG0030 events0 affected53 at risk
Transient ischaemic attack	Cardiac disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003
Erythrodermic psoriasis	Skin and subcutaneous tissue disorders	MedDRA version 24.0	Systematic Assessment	EG0000 events0 affected51 at risk EG0010 events0 affected48 at risk EG0021 events1 affected50 at risk EG003