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| ID | Type | Description | Link |
|---|---|---|---|
| COMPARE | Other Identifier | Alias Study Number | |
| 2018-002573-21 | EudraCT Number |
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B7451029 is a Phase 3 study to investigate PF-04965842 in adult patients who have moderate to severe atopic dermatitis and use background topical therapy. The efficacy of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily will be evaluated relative to placebo over 12 weeks. The efficacy of the two dosage strengths of PF-04965842 will be compared with dupilumab in terms of pruritus relief at 2 weeks. The two dosage strengths of PF-04965842 and dupilumab 300 mg injected subcutaneously once every two weeks (with a loading dose of 600 mg injected on the first day) will also be evaluated relative to placebo over 16 weeks. The safety of the investigational products will be evaluated over the duration of the study. Subjects will use non-medicated emollient at least twice a day and medicated topical therapy such as corticosteroids, calcineurin inhibitors or PDE4 inhibitors, as per protocol guidance, to treat active lesions during the study. Subjects who are randomized to receive one of the two dosage strengths of PF-04965842 will also receive placebo injectable study drug every two weeks until Week 16 and then will continue on receiving only the oral study drug for 4 weeks. Subjects who are randomized to receive dupilumab injections every two weeks will also receive oral placebo to be taken once daily until Week 16 and will then continue to receive only the oral placebo for 4 weeks. Subjects who are randomized to the placebo arms, will receive both daily oral placebo and injectable placebo every two weeks until Week 16, after which they will receive either 100 mg or 200 mg of PF-04965842 taken orally once daily for 4 weeks, dependent upon which arm they have been allocated to. Eligible subjects will have an option to enter a long-term extension study after completing 20 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04965842 100 mg + Placebo Inj followed by PF-04965842 100mg | Experimental | Once-daily oral PF-04965842 100 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 100 mg from Week 16 to Week 20 |
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| PF-04965842 200 mg + Placebo Inj followed by PF-04965842 200mg | Experimental | Once-daily oral PF-04965842 200 mg + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral PF-04965842 200 mg from Week 16 to Week 20 |
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| Dupilumab Injection + Oral Placebo followed by Oral Placebo | Active Comparator | Dupilumab injected subcutaneously once every 2 weeks + once-daily oral Placebo from Day 1 until Week 16 followed by once-daily oral Placebo from Week 16 to Week 20 |
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| Oral Placebo + Placebo Inj followed by 100 mg PF-04965842 | Placebo Comparator | Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 100 mg PF-04965842 from Week 16 to Week 20 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04965842 100 mg | Drug | PF-04965842 100 mg, administered as two tablets to be taken orally once daily as follows:
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Week 12 | IGA assessed severity of atopic dermatitis (AD) on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded scalp, palms and sole. | Baseline (the last measurement prior to first dosing on Day 1), Week 12 |
| Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12 | EASI evaluates severity of participants with AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity. | Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 2, 4, 8, 12, 16 |
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Inclusion Criteria:
Male or female subjects aged 18 years or older at the time of informed consent
Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS severity 4)
Documented recent history (within 6 months before the screening visit) of inadequate response to treatment with medicated topical therapy for AD for at least 4 weeks, or who have required systemic therapies for control of their disease.
Must be willing and able to comply with standardized background topical therapy, as per protocol guidelines throughout the study
Female subjects who are of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
Female subjects of non-childbearing potential must meet at least 1 of the following criteria:
All other female subjects (including female subjects with tubal ligations) are considered to be of childbearing potential.
-If receiving concomitant medications for any reason other than AD, must be on a stable regimen prior to Day 1 and through the duration of the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of Alabama, LLC | Birmingham | Alabama | 35209 | United States | ||
| The University Of Alabama At Birmingham |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42365219 | Derived | Weidinger S, Reich K, Issa N, Hong HC, Bunick CG, Biswas P, Chan G, Guler E, Watkins M, Alderfer J. Abrocitinib Achieves Early and Complete/Near-Complete Skin Clearance Plus Itch-Free State in Atopic Dermatitis: Phase 3 Pooled Post Hoc Analysis. Dermatol Ther (Heidelb). 2026 Jun 27. doi: 10.1007/s13555-026-01833-8. Online ahead of print. | |
| 42162528 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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The study had treatment period of 20 weeks. The first part of this treatment period consists of a 16-week randomized, double-blind, placebo-controlled, double-dummy treatment period where participants received PF-04965842, dupilumab and placebo. The randomization and double-blind was maintained during the final 4 weeks of the treatment period, but participants only received PF-04965842 and placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo up to Week 16 | Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16. |
| FG001 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period: First Part 16 Weeks |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 29, 2019 | Dec 17, 2020 |
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| Oral Placebo + Placebo Inj followed by 200 mg PF-04965842 |
| Placebo Comparator |
Once-daily oral Placebo + Placebo injected subcutaneously once every 2 weeks from Day 1 until Week 16 followed by once-daily oral 200 mg PF-04965842 from Week 16 to Week 20 |
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| PF-04965842 200 mg | Drug | PF-04965842 200 mg, administered as two tablets to be taken orally once daily as follows:
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| Dupilumab | Drug | Two subcutaneous injections of Dupilumab 300 mg as a loading dose administered on Day 1 (for a total of 600 mg) followed by one injection once every two weeks (q2w) until Week 16. |
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| Oral Placebo | Drug | Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows:
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| Injectable Placebo | Drug | Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16. |
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| Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp. | Baseline, Week 2, 4, 8 and 16 |
| Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | Baseline, Week 2, 4, 8 and 16 |
| Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | Baseline, Week 2, 4, 8, 12 and 16 |
| Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | Baseline, Week 2, 4, 8,12 and 16 |
| Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | Baseline, Week 2, 4, 8, 12 and 16 |
| Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS | Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity. | Baseline up to Week 16 |
| Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD. | Baseline, Week 2, 4, 8, 12 and 16 |
| Percentage BSA at Week 18 and 20 | 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD. | Week 18 and 20 |
| Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Participant responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity. | Baseline, Week 2, 4, 8, 12 and 16 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. | Baseline, Week 2, 12 and 16 |
| DLQI at Week 20 | DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. | Week 20 |
| Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16 | EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state. | Baseline, Week 12 and 16 |
| Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16 | EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. | Baseline, Week 12 and 16 |
| EQ-5D-5L- Index Value at Week 20 | EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state. | Week 20 |
| EQ-5D-5L- VAS Score at Week 20 | EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. | Week 20 |
| Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16 | HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety. | Baseline, Weeks 12 and 16 |
| Change From Baseline in HADS - Depression Scale at Week 12 and 16 | HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms. | Baseline, Week 12 and 16 |
| HADS - Anxiety Scale at Week 20 | HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety. | Week 20 |
| HADS - Depression Scale at Week 20 | HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms. | Week 20 |
| Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16 | POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity. | Baseline, Week 12 and 16 |
| POEM at Week 20 | POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity. | Week 20 |
| Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. | Baseline, Week 1 to Week 16 |
| PSAAD Total Score at Week 18 and 20 | PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. | Week 18 and 20 |
| Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. | Baseline, Week 2, 4, 8 12 and 16 |
| Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. | Baseline, Week 2, 4, 8 12 and 16 |
| Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. | Baseline, Week 2, 4, 8 12 and 16 |
| SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. | Week 18 and 20 |
| Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16 | Number of days when a corticosteroid as a concomitant medication was not used up to Week 16 is reported as Least square mean in this outcome measure. | Baseline up to Week 16 |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Marvel Research, LLC | Huntington Beach | California | 92647 | United States |
| Alliance Research Centers | Laguna Hills | California | 92653 | United States |
| Allergy & Asthma Care Center of Southern California | Long Beach | California | 90808 | United States |
| Allergy & Asthma Associates of Southern California dba Southern California Research | Mission Viejo | California | 92691 | United States |
| Dermatology Specialists, Inc. | Murrieta | California | 92562 | United States |
| MedDerm Associates | San Diego | California | 92103 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Synexus Clinical Research US, Inc. | Santa Rosa | California | 95405 | United States |
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | United States |
| Renaissance Research and Medical Group, Inc | Cape Coral | Florida | 33991 | United States |
| C & R Research Services USA, Inc | Coral Gables | Florida | 33134 | United States |
| Florida Academic Centers Research and Education, LLC | Coral Gables | Florida | 33134 | United States |
| Moonshine Research Center, Inc. | Doral | Florida | 33166 | United States |
| Solutions Through Advanced Research, Inc. | Jacksonville | Florida | 32256 | United States |
| Olympian Clinical Research | Largo | Florida | 33770 | United States |
| Savin Medical Group LLC | Miami | Florida | 33126 | United States |
| Wellness Clinical Research, LLC | Miami Lakes | Florida | 33016 | United States |
| ForCare Clinical Research | Tampa | Florida | 33613 | United States |
| Research Institute of Southeast, LLC | West Palm Beach | Florida | 33401 | United States |
| Research Institute of the Southeast, LLC | West Palm Beach | Florida | 33401 | United States |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | United States |
| Idaho Allergy and Research | Eagle | Idaho | 83616 | United States |
| ASR, LLC | Nampa | Idaho | 83687 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Midwest Allergy Sinus Asthma, SC | Normal | Illinois | 61761 | United States |
| NorthShore University HealthSystem | Skokie | Illinois | 60077 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Dundee Dermatology | West Dundee | Illinois | 60118 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| Forefront Dermatology, S.C. | Louisville | Kentucky | 40202 | United States |
| Meridian Clinical Research, LLC | Baton Rouge | Louisiana | 70808 | United States |
| Clinical Research Institute, Inc. | Minneapolis | Minnesota | 55402 | United States |
| Skin Laser and Surgery Specialists of NY and NJ | Hackensack | New Jersey | 07601 | United States |
| Forest Hills Dermatology Group | Kew Gardens | New York | 11374 | United States |
| Juva Skin and Laser Center | New York | New York | 10022 | United States |
| TrialSpark, Inc (Russell Cohen) | Oceanside | New York | 11572 | United States |
| Cary Dermatology Center, PA | Cary | North Carolina | 27511 | United States |
| PMG Research of Raleigh, LLC d/b/a PMG Research of Cary | Cary | North Carolina | 27518 | United States |
| Medication Management, LLC | Greensboro | North Carolina | 27408 | United States |
| PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare | Statesville | North Carolina | 28625 | United States |
| Winston-Salem Dermatology and Surgery Center, PLLC | Winston-Salem | North Carolina | 27103 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Newton Clinical Research | Oklahoma City | Oklahoma | 73120 | United States |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| Portland Clinical Research dba Columbia Allergy & Asthma Clinic | Clackamas | Oregon | 97015 | United States |
| Crisor, LLC | Medford | Oregon | 97504 | United States |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | United States |
| Paddington Testing Co, Inc. | Philadelphia | Pennsylvania | 19103 | United States |
| Synexus Clinical Research US, Inc. | Anderson | South Carolina | 29621 | United States |
| Synexus Clinical Research US. Inc. | Greer | South Carolina | 29651 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Arlington Research Center, Inc. | Arlington | Texas | 76011 | United States |
| Austin Institute for Clinical Research, Inc. | Austin | Texas | 78705 | United States |
| Center for Clinical Studies, LTD. LLP | Houston | Texas | 77004 | United States |
| Center for Clinical Studies, LTD. LLP | Webster | Texas | 77598 | United States |
| Jordan Valley Dermatology Center | West Jordan | Utah | 84088 | United States |
| Virginia Dermatology and Skin Cancer Center | Norfolk | Virginia | 23502 | United States |
| Velocity Urgent Care | Norfolk | Virginia | 23518 | United States |
| Woden Dermatology | Phillip | Australian Capital Territory | 2606 | Australia |
| Australian Clinical Research Network | Maroubra | New South Wales | 2035 | Australia |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| Veracity Clinical Research Pty Ltd | Woolloongabba | Queensland | 4102 | Australia |
| North Eastern Health Specialists | Hectorville | South Australia | 5073 | Australia |
| Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Emeritus Research | Camberwell | Victoria | 3124 | Australia |
| Skin and Cancer Foundation Inc | Carlton | Victoria | 3053 | Australia |
| Sinclair Dermatology | East Melbourne | Victoria | 3002 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| DCC 2/Sofia EOOD | Sofia | 1000 | Bulgaria |
| "DCC Aleksandrovska" EOOD | Sofia | 1431 | Bulgaria |
| Dermatology Clinic "Sofia" Ltd | Sofia | 1756 | Bulgaria |
| "Mc Synexus Sofia" Eood | Sofia | 1784 | Bulgaria |
| Medical Centre Synexus Sofia EOOD-branch Stara Zagora | Stara Zagora | 6000 | Bulgaria |
| "DCC "Mladost-M Varna" OOD | Varna | 9000 | Bulgaria |
| Pacific Dermaesthetics Inc. | Vancouver | British Columbia | V6H4E1 | Canada |
| Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | R3M3Z4 | Canada |
| DermEffects | London | Ontario | N6H 5L5 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| North Bay Dermatology Centre | North Bay | Ontario | P1B 3Z7 | Canada |
| SKiN Centre for Dermatology | Peterborough | Ontario | K9J5K2 | Canada |
| Toronto Research Centre | Toronto | Ontario | M3H5Y8 | Canada |
| AvantDerm Clinical Research | Toronto | Ontario | M5A 3R6 | Canada |
| Manna Research (Toronto) | Toronto | Ontario | M9W 4L6 | Canada |
| Innovaderm Research Inc. | Montreal | Quebec | H2X 2V1 | Canada |
| Dr. Rachel Asiniwasis Medical Prof Corp | Regina | Saskatchewan | S4V1R9 | Canada |
| Centro Medico SkinMed Limitada | Santiago | Santiago Metropolitan | 7580206 | Chile |
| Clinica Dermacross S.A. | Santiago | Santiago Metropolitan | 7640881 | Chile |
| MIRES (M y F Estudios Clínicos Limitada) | Santiago | Santiago Metropolitan | 7750495 | Chile |
| Centro Internacional de Estudios Clinicos - CIEC | Santiago | Santiago Metropolitan | 8420383 | Chile |
| Dermamedica S.R.O. | Náchod | 547 01 | Czechia |
| CCR Ostrava, s.r.o. | Ostrava | 702 00 | Czechia |
| BENU Lekarna | Pardubice | 530 02 | Czechia |
| CCR Czech, a.s. | Pardubice | 530 02 | Czechia |
| Nemocnice Pardubickeho kraje a.s., Pardubicka nemocnice, odd Dermatologie | Pardubice | 532 03 | Czechia |
| Sanatorium profesora Arenbergera | Prague | 11000 | Czechia |
| Lekarna U sv. Ignace | Prague | 120 00 | Czechia |
| Synexus Czech, s.r.o. | Prague | 120 00 | Czechia |
| CCR Prague, s.r.o. | Prague | 130 00 | Czechia |
| Licca Clinical Research Institute | Augsburg | 86179 | Germany |
| Fachklinik Bad Bentheim | Bad Bentheim | 48455 | Germany |
| Klinikum Bielefeld Rosenhohe | Bielefeld | 33647 | Germany |
| Universitätsklinikum Bonn AöR | Bonn | 53105 | Germany |
| Klinische Forschung Dresden GmbH | Dresden | 01069 | Germany |
| Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden | Dresden | 01307 | Germany |
| IKF Pneumologie GmbH & Co KG, Institut fuer klinische Forschung | Frankfurt | 60596 | Germany |
| Universitätsklinikum und Poliklinik für Dermatologie und Venerologie | Halle | 06120 | Germany |
| Universitaetsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| Studienzentrum Dr. med. Beate Schwarz | Langenau | 89129 | Germany |
| SIBAmed Studienzentrum GmbH & Co KG | Leipzig | 04103 | Germany |
| Universitaetsklinikum Schleswig-Holstein/Campus Luebeck | Lübeck | 23538 | Germany |
| Dermatologische Gemeinschaftspraxis Dres. Scholz, Sebastian, Schilling | Mahlow | 15831 | Germany |
| Universitätsklinikum Marburg | Marburg | 35043 | Germany |
| University of Muenster | Münster | 48149 | Germany |
| SE AOK Bor-, Nemikortani es Boronkologiai Klinika | Budapest | 1085 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Synexus Magyarország Egészségügyi Szolgáltató Kft. Synexus Gyula DRS | Gyula | 5700 | Hungary |
| Trial Pharma Kft. | Püspökladány | 4150 | Hungary |
| Medmare Bt | Veszprém | 8200 | Hungary |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Universita Cattolica del Sacro Cuore | Roma | RM | 00168 | Italy |
| AOU Policlinico di Modena, Struttura Complessa di Dermatologia | Modena | 41124 | Italy |
| Kawashima Dermatology Clinic | Ichikawa | Chiba | 272-0033 | Japan |
| Takagi Dermatological Clinic | Obihiro | Hokkaido | 080-0013 | Japan |
| Dermatology Shimizu Clinic | Kobe | Hyōgo | 657-0846 | Japan |
| Noguchi Dermatology Clinic | Kamimashiki-gun | Kumamoto | 861-3101 | Japan |
| Osaka Habikino Medical Center | Habikino | Osaka | 583-8588 | Japan |
| Kume Clinic | Sakai | Osaka | 593-8324 | Japan |
| Iidabashi Skin Clinic | Chiyoda-ku | Tokyo | 102-0072 | Japan |
| Fukuwa Clinic | Chuo-ku | Tokyo | 104-0031 | Japan |
| Tokyo Medical University Hospital | Shinjyuku-ku | Tokyo | 160-0023 | Japan |
| Hoshikuma Dermatology・Allergy Clinic | Fukuoka | 814-0171 | Japan |
| Matsuda Tomoko Dermatological Clinic | Fukuoka | 819-0167 | Japan |
| Sanrui Hifuka | Saitama | 330-0854 | Japan |
| Riga 1st Hospital, Clinic for Dermatology and STD | Riga | LV-1001 | Latvia |
| Aesthetic dermatology clinic of Prof. J. Kisis | Riga | LV-1003 | Latvia |
| Childrens Clinical University Hospital State SLLC | Riga | LV-1004 | Latvia |
| Health and aesthetics Ltd | Riga | LV-1009 | Latvia |
| Outpatient Clinic of Ventspils | Ventspils | LV-3601 | Latvia |
| Cryptex Investigación Clínica, S.A. de C.V. | Cuauhtémoc | Mexico City | 06100 | Mexico |
| Arke Estudios Clinicos S.A. de C.V. | Cuauhtémoc | Mexico City | 06700 | Mexico |
| Eukarya Pharmasite S.C. | Monterrey | Nuevo León | 64718 | Mexico |
| SMIQ. S. de R. L. de C.V. | Querétaro | 76070 | Mexico |
| NZOZ Specjalistyczny Osrodek Dermatologiczny "DERMAL" | Bialystok | 15-453 | Poland |
| Centrum Medyczne SENSEMED | Chorzów | 41-500 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Czestochowie | Częstochowa | 42-202 | Poland |
| COPERNICUS-SZPITAL Oddzial Dermatologii | Gdansk | 80-152 | Poland |
| Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii | Gdansk | 80-214 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Gdyni | Gdynia | 81-537 | Poland |
| MCBK | Grodzisk Mazowiecki | 05-825 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Katowicach | Katowice | 40-040 | Poland |
| Care Clinic Centrum Medyczne | Katowice | 40-568 | Poland |
| Centrum Medyczne Angelius Provita | Katowice | 40-611 | Poland |
| Gabinet Dermatologiczny Beata Krecisz | Kielce | 25-155 | Poland |
| Centrum Medyczne Plejady | Krakow | 30-363 | Poland |
| AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc | Krakow | 31-302 | Poland |
| Krakowskie Centrum Medyczne Sp. z o.o. | Krakow | 31-501 | Poland |
| Centrum Medyczne Promed | Krakow | 31-513 | Poland |
| Prywatna Praktyka Lekarska - Adam Smialowski | Ksawerów | 95-054 | Poland |
| Dermoklinika-Centrum Medyczne s.c. M. Kierstan, J. Narbutt, A. Lesiak | Lodz | 90-436 | Poland |
| Salve Medica Sp. z o.o. Sp. k. | Lodz | 91-211 | Poland |
| KO-MED Centra Kliniczne Lublin II | Lublin | 20-362 | Poland |
| NZOZ "Med-Laser" Borzecki Spolka Jawna | Lublin | 20-406 | Poland |
| Dermedic Jacek Zdybski | Ostrowiec Świętokrzyski | 27-400 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Poznaniu | Poznan | 60-702 | Poland |
| Clinical Research Center Spolka z ograniczona odpowiedzialnoscia MEDIC-R Sp.k. | Poznan | 60-848 | Poland |
| LIFT-MED Spolka Akcyjna | Rybnik | 44-200 | Poland |
| Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina, Klinika Dermatologii | Rzeszów | 35-055 | Poland |
| EMED Centrum Uslug Medycznych Ewa Smialek | Rzeszów | 35-205 | Poland |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| Medycyna Kliniczna | Warsaw | 00-874 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Warszawie | Warsaw | 01-192 | Poland |
| MTZ Clinical Research Sp. z o.o. | Warsaw | 02-106 | Poland |
| RCMed Oddzial Warszawa | Warsaw | 02-657 | Poland |
| Carpe Diem Centrum Medycyny Estetycznej | Warsaw | 02-661 | Poland |
| "REUMATIKA - Centrum Reumatologii" NZOZ | Warsaw | 02-691 | Poland |
| Klinika Ambroziak Sp. z o.o. | Warsaw | 02-758 | Poland |
| EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej | Wroclaw | 50-220 | Poland |
| Synexus Polska Sp. z o.o. Oddzial we Wroclawiu | Wroclaw | 50-381 | Poland |
| Lukasz Matusiak "4Health" | Wroclaw | 50-566 | Poland |
| Centrum Medyczne Oporow | Wroclaw | 52-416 | Poland |
| SUMMIT CLINICAL RESEARCH, s.r.o. | Bratislava | 831 01 | Slovakia |
| Nemocnica Kosice-Saca, a.s., 1. sukromna nemocnica | Kosice-Saca | 040 15 | Slovakia |
| Pedi-Derma s.r.o. | Košice | 04001 | Slovakia |
| Fakultna nemocnica s poliklinikou Nove Zamky, Dermatovenerologicka Klinika | Nové Zámky | 940 34 | Slovakia |
| SANARE spol. s.r.o., Dermatovenerologicka ambulancia | Svidník | 089 01 | Slovakia |
| Korea University Ansan Hospital | Ansan-si | Gyeonggi-do | 15355 | South Korea |
| Soon Chun Hyang University Bucheon Hospital | Bucheon-si | Gyeonggi-do | 14584 | South Korea |
| Chungnam National University Hospital CNUH | Daejeon | 35015 | South Korea |
| The Catholic University of Korea, Incheon St. Mary's Hospital | Incheon | 21431 | South Korea |
| Severance Hospital, Yonsei Univ. Health System | Seoul | 03722 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| Hallym University Kangnam Sacred Heart Hospital | Seoul | 07441 | South Korea |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08016 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario Fundacion Alcorcon | Alcorcón | Madrid | 28922 | Spain |
| Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario y Politecnico La Fe | Valencia | 46026 | Spain |
| Taipei Veterans General Hospital | Taipei | Taiwan (r.o.c) | 11217 | Taiwan |
| Chung Shan Medical University Hospital (CSMUH) | Taichung | 40201 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Cheng-Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Medinova Research -West London Dedicated Research Centre | Wokingham | Berkshire | RG40 1XS | United Kingdom |
| Derriford Hospital | Plymouth | Devon | PL6 8DH | United Kingdom |
| Medinova Research, East London Dedicated Research Centre | Romford | Essex | RM1 3PJ | United Kingdom |
| Guy's Hospital-Guy's and St Thomas NHS Foundation Trust | London | Greater London | SE1 9RT | United Kingdom |
| Medinova Research, South London Clinical Trial Centre | Sidcup | KENT | DA14 6LT | United Kingdom |
| MeDiNova Research North London Dedicated Research Centre | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Medinova Research | Yaxley | Peterborough | PE7 3JL | United Kingdom |
| Medinova Research, Warwickshire Dedicated Research Centre | Kenilworth | Warwickshire | CV8 1JD | United Kingdom |
| Medinova, Yorkshire Quality Research Site | Shipley | WEST Yorkshire | BD18 3SA | United Kingdom |
| MeDiNova Northamptonshire Dedicated Research Centre | Corby | NN18 9EZ | United Kingdom |
| West Glasgow ACH, NHS Greater Glasgow and Clyde | Glasgow | G3 8SJ | United Kingdom |
| Silverberg JI, Simpson EL, Farooqui SA, Chan G, Biswas P, Guler E. Efficacy and Safety of Variable-Dose Versus Continuous-Dose Abrocitinib Treatment in Patients with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis. Dermatol Ther (Heidelb). 2026 May 20. doi: 10.1007/s13555-026-01778-y. Online ahead of print. |
| 42084697 | Derived | Yosipovitch G, Gooderham MJ, Elmariah SB, Bonfanti G, Edwards RA, Gregoriou S, Biswas P, Myers DE, Alderfer J, Guler E, Koulias C. Itch Relief and Quality-of-Life Improvement with Abrocitinib and Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of JADE COMPARE and JADE DARE. Am J Clin Dermatol. 2026 May 5. doi: 10.1007/s40257-026-01030-5. Online ahead of print. |
| 40987931 | Derived | Simpson EL, Silverberg JI, Geng B, Carrascosa JM, Bieber T, Brunner PM, Staumont-Salle D, Ji C, Biswas P, Feeney C, Hernandez-Martin I, Rebollo Laserna FJ, Koppensteiner H. Do Allergic Comorbidities Alter the Efficacy and Safety of Abrocitinib or Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis? Dermatol Ther (Heidelb). 2025 Nov;15(11):3391-3407. doi: 10.1007/s13555-025-01516-w. Epub 2025 Sep 23. |
| 39104653 | Derived | Silverberg JI, Thyssen JP, Lazariciu I, Myers DE, Guler E, Chovatiya R. Abrocitinib may improve itch and quality of life in patients with itch-dominant atopic dermatitis. Skin Health Dis. 2024 May 5;4(4):e382. doi: 10.1002/ski2.382. eCollection 2024 Aug. |
| 38896380 | Derived | Armstrong AW, Alexis AF, Blauvelt A, Silverberg JI, Feeney C, Levenberg M, Chan G, Zhang F, Fostvedt L. Predicting Abrocitinib Efficacy at Week 12 Based on Clinical Response at Week 4: A Post Hoc Analysis of Four Randomized Studies in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Jul;14(7):1849-1861. doi: 10.1007/s13555-024-01183-3. Epub 2024 Jun 19. |
| 37213005 | Derived | Simpson EL, Silverberg JI, Thyssen JP, Viguier M, Thaci D, de Bruin-Weller M, Weidinger S, Chan G, DiBonaventura M, Biswas P, Feeney C, Koulias C, Cork MJ. Efficacy and Safety of Abrocitinib in Patients with Severe and/or Difficult-to-Treat Atopic Dermatitis: A Post Hoc Analysis of the Randomized Phase 3 JADE COMPARE Trial. Am J Clin Dermatol. 2023 Jul;24(4):609-621. doi: 10.1007/s40257-023-00785-5. Epub 2023 May 22. |
| 36512175 | Derived | Stander S, Kwatra SG, Silverberg JI, Simpson EL, Thyssen JP, Yosipovitch G, Zhang F, Cameron MC, Cella RR, Valdez H, DiBonaventura M, Feeney C. Early Itch Response with Abrocitinib Is Associated with Later Efficacy Outcomes in Patients with Moderate-to-Severe Atopic Dermatitis: Subgroup Analysis of the Randomized Phase III JADE COMPARE Trial. Am J Clin Dermatol. 2023 Jan;24(1):97-107. doi: 10.1007/s40257-022-00738-4. Epub 2022 Dec 13. |
| 36108923 | Derived | Reich K, Lio PA, Bissonnette R, Alexis AF, Lebwohl MG, Pink AE, Kabashima K, Boguniewicz M, Nowicki RJ, Valdez H, Zhang F, DiBonaventura M, Cameron MC, Clibborn C. Magnitude and Time Course of Response to Abrocitinib for Moderate-to-Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2022 Dec;10(12):3228-3237.e2. doi: 10.1016/j.jaip.2022.08.042. Epub 2022 Sep 13. |
| 35297025 | Derived | Alexis A, de Bruin-Weller M, Weidinger S, Soong W, Barbarot S, Ionita I, Zhang F, Valdez H, Clibborn C, Yin N. Rapidity of Improvement in Signs/Symptoms of Moderate-to-Severe Atopic Dermatitis by Body Region with Abrocitinib in the Phase 3 JADE COMPARE Study. Dermatol Ther (Heidelb). 2022 Mar;12(3):771-785. doi: 10.1007/s13555-022-00694-1. Epub 2022 Mar 17. |
| 34775830 | Derived | Bieber T, Simpson EL, Silverberg JI, Thaci D, Paul C, Pink AE, Kataoka Y, Chu CY, DiBonaventura M, Rojo R, Antinew J, Ionita I, Sinclair R, Forman S, Zdybski J, Biswas P, Malhotra B, Zhang F, Valdez H. Comparing abrocitinib and dupilumab in the treatment of atopic dermatitis: a plain language summary. Immunotherapy. 2022 Jan;14(1):5-14. doi: 10.2217/imt-2021-0224. Epub 2021 Nov 15. |
| 34406619 | Derived | Simpson EL, Silverberg JI, Nosbaum A, Winthrop KL, Guttman-Yassky E, Hoffmeister KM, Egeberg A, Valdez H, Zhang M, Farooqui SA, Romero W, Thorpe AJ, Rojo R, Johnson S. Integrated Safety Analysis of Abrocitinib for the Treatment of Moderate-to-Severe Atopic Dermatitis From the Phase II and Phase III Clinical Trial Program. Am J Clin Dermatol. 2021 Sep;22(5):693-707. doi: 10.1007/s40257-021-00618-3. Epub 2021 Aug 18. |
| 33761207 | Derived | Bieber T, Simpson EL, Silverberg JI, Thaci D, Paul C, Pink AE, Kataoka Y, Chu CY, DiBonaventura M, Rojo R, Antinew J, Ionita I, Sinclair R, Forman S, Zdybski J, Biswas P, Malhotra B, Zhang F, Valdez H; JADE COMPARE Investigators. Abrocitinib versus Placebo or Dupilumab for Atopic Dermatitis. N Engl J Med. 2021 Mar 25;384(12):1101-1112. doi: 10.1056/NEJMoa2019380. |
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 milligram (mg) tablet orally once daily post Week 16 up to Week 20. |
| FG002 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| FG003 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. |
| FG004 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| FG005 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, followed by administration of oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. |
| Treated/ Safety Analysis Set |
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| Full Analysis Set |
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| NOT COMPLETED |
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| Treatment Period: Final 4 Weeks |
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Safety analysis set included all randomized participants who received at least 1 dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo up to Week 16 | Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16. |
| BG001 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. |
| BG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, followed by administration of PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| BG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, followed by administration of oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. |
| BG004 | Total | Total of all reporting groups |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and a Reduction of Greater Than or Equal to (>=) 2 Points From Baseline at Week 12 | IGA assessed severity of atopic dermatitis (AD) on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded scalp, palms and sole. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline (the last measurement prior to first dosing on Day 1), Week 12 |
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| Primary | Percentage of Participants Achieving Eczema Area and Severity Index (EASI) Response >=75 Percent (%) Improvement From Baseline at Week 12 | EASI evaluates severity of participants with AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 12 |
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| Secondary | Percentage of Participants With at Least 4 Points Improvement in the Numerical Rating Scale (NRS) for Severity of Pruritus From Baseline at Day 2-15, Week 2, 4, 8, 12 and 16 | Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and Week 2, 4, 8, 12, 16 |
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| Secondary | Percentage of Participants Achieving IGA Response of Clear (0) or Almost Clear (1) and a Reduction of >=2 Points From Baseline at Week 2, 4, 8 and 16 | IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 2, 4, 8 and 16 |
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| Secondary | Percentage of Participants Achieving EASI Response >=75% Improvement From Baseline at Week 2, 4, 8 and 16 | EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 2, 4, 8 and 16 |
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| Secondary | Percentage of Participants Achieving EASI Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 2, 4, 8, 12 and 16 |
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| Secondary | Percentage of Participants Achieving EASI Response >=90% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 2, 4, 8,12 and 16 |
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| Secondary | Percentage of Participants Achieving EASI Response =100% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | EASI evaluates severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 2, 4, 8, 12 and 16 |
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| Secondary | Time From Baseline to First Achieve at Least 4 Points Improvement in the Severity of Pruritus NRS | Participants were asked to assess their worst pruritus/itching due to AD over the past 24 hours on an NRS scale ranged from 0 (no itching) to 10 (worst possible itching), where higher scores indicated greater severity. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Participants with a baseline numeric rating scale score for severity of pruritus >=4 were included in the analysis. | Posted | Median | 95% Confidence Interval | Days | Baseline up to Week 16 |
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| Secondary | Change From Baseline in Percentage Body Surface Area (BSA) at Week 2, 4, 8, 12 and 16 | 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage BSA | Baseline, Week 2, 4, 8, 12 and 16 |
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| Secondary | Percentage BSA at Week 18 and 20 | 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD. | Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | Percentage BSA | Week 18 and 20 |
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| Secondary | Change From Baseline in Patient Global Assessment (PtGA) at Week 2, 4, 8, 12 and 16 | Participant responded to the following question: "Overall, how would you describe your Atopic Dermatitis right now?" on a scale: 0= clear; 1= almost clear; 2= mild; 3= moderate; and 4= severe. Higher scores indicated more severity. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 2, 4, 8, 12 and 16 |
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| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 2, 12 and 16 | DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 2, 12 and 16 |
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| Secondary | DLQI at Week 20 | DLQI is a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicated more impact on quality of life. Scores from all 10 questions added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants. | Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 20 |
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| Secondary | Change From Baseline in EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Index Value at Week 12 and 16 | EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 12 and 16 |
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| Secondary | Change From Baseline in EQ-5D-5L Visual Analogue Scale (VAS) Score at Week 12 and 16 | EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 12 and 16 |
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| Secondary | EQ-5D-5L- Index Value at Week 20 | EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile and an optional VAS. EQ-5D health state profile had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study, range from 1 to -0.109. Higher (positive) scores = better health state. | Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 20 |
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| Secondary | EQ-5D-5L- VAS Score at Week 20 | EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. | Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 20 |
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| Secondary | Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety Scale at Week 12 and 16 | HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-Anxiety (HADS-A) scale and HADS-Depression (HADS-D) scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Weeks 12 and 16 |
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| Secondary | Change From Baseline in HADS - Depression Scale at Week 12 and 16 | HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 12 and 16 |
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| Secondary | HADS - Anxiety Scale at Week 20 | HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-A: sum of all 7 items resulted in score range of 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicating greater severity of anxiety. | Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 20 |
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| Secondary | HADS - Depression Scale at Week 20 | HADS: participant rated 14-item questionnaire. HADS consisted of 2 subscales: HADS-A scale and HADS-D scale, both of these subscales comprised of 7 items each. Each item was rated on a 4-point scale, score range from 0 to 3, where higher scores indicates more anxiety/depression symptoms. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks). HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). HADS-D: sum of all 7 items resulted in score range of 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicating greater severity of depression symptoms. | Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 20 |
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| Secondary | Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 12 and 16 | POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 12 and 16 |
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| Secondary | POEM at Week 20 | POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as following: "no days (0)", "1-2 days (1)", "3-4 days (2)", "5-6 days (3)" and "every day (4)". The score ranges from 0 to 28, where higher score indicated greater severity. | Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Week 20 |
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| Secondary | Change From Baseline in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) Total Score Week 1 to Week 16 | PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 1 to Week 16 |
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| Secondary | PSAAD Total Score at Week 18 and 20 | PSAAD is a daily participant reported symptom electronic diary. Participants rated their symptoms of AD over the past 24 hours, using 11 items (itchy skin, painful skin, dry skin, flaky skin, cracked skin, bumpy skin, red skin, discolored skin [lighter or darker], bleeding from skin, seeping or oozing fluid from skin [other than blood], and skin swelling). Participant had to think about all the areas of their body affected by their skin condition and chose the number that best described their experience for each of the 11 items, from 0 (no symptoms) to 10 (extreme symptoms), higher scores signified worse skin condition. Total PSAAD score = arithmetic mean of 11 items, 0 (no symptoms) to 10 (extreme symptoms), where higher score = worse skin condition. | Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Week 18 and 20 |
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| Secondary | Percentage of Participants With Scoring Atopic Dermatitis (SCORAD) Response >=50% Improvement From Baseline at Week 2, 4, 8, 12 and 16 | SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 2, 4, 8 12 and 16 |
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| Secondary | Percentage of Participants With SCORAD Response >=75% Improvement From Baseline at Week 2, 4, 8 12 and 16 | SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Week 2, 4, 8 12 and 16 |
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| Secondary | Change From Baseline in SCORAD Visual Analogue Scale (VAS) of Itch and Sleep Loss at Week 2, 4, 8 12 and 16 | SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline, Week 2, 4, 8 12 and 16 |
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| Secondary | SCORAD VAS of Itch and Sleep Loss at Week 18 and 20 | SCORAD: scoring index for AD combining extent, severity, subjective symptoms. Extent (A): rule of 9 was used to calculate BSA affected by AD as a % of whole BSA for each body region- head and neck 9%; upper limbs 9% each; lower limbs 18% each; anterior trunk 18%; back 18%; 1% for genitals. The score for each body region was added to determine A (0-100). Severity (B): severity of each sign (erythema; edema; oozing; excoriation; skin thickening; dryness) was assessed as none=0, mild=1, moderate=2,severe=3. The severity scores were summed to give B (0-18). Subjective symptoms (C): pruritus and sleep, each of these 2 were scored by participant/caregiver using visual analogue scale (VAS) where "0" = no itch/no sleeplessness and "10" = the worst imaginable itch/sleeplessness, higher scores=worse symptoms. Scores for itch and sleeplessness were added to give 'C' (0-20). The SCORAD for an individual was calculated: A/5 + 7*B/2 + C; range from 0 to 103; higher values of SCORAD=worse outcome. | Full analysis set for post Week 16 included all randomized participants who received at least 1 dose of study medication post Week 16. Here, 'Number Analyzed' = participants evaluable for this outcome measure at specified time points. | Posted | Mean | Standard Deviation | units on a scale | Week 18 and 20 |
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| Secondary | Least Square Mean of Number of Steroid-free Days From Baseline up to Week 16 | Number of days when a corticosteroid as a concomitant medication was not used up to Week 16 is reported as Least square mean in this outcome measure. | Full analysis set till Week 16 included all randomized participants who received at least 1 dose of study medication up to Week 16. | Posted | Least Squares Mean | 95% Confidence Interval | Days | Baseline up to Week 16 |
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For reporting arms till Week 16 analysis: Baseline up to Week 16; For reporting arms post Week 16 analysis: Week 16 to Week 24 (28 days after last dose of study drug)
Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis set included all randomized participants who received at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo up to Week 16 | Participants were randomized to receive oral placebo matched to PF-04965842 once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 till Week 16. | 0 | 131 | 5 | 131 | 68 | 131 |
| EG001 | PF-04965842 100 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. | 0 | 238 | 6 | 238 | 121 | 238 |
| EG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. | 0 | 226 | 2 | 226 | 140 | 226 |
| EG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. | 0 | 242 | 2 | 242 | 120 | 242 |
| EG004 | Placebo up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. | 0 | 60 | 0 | 60 | 13 | 60 |
| EG005 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. | 0 | 57 | 0 | 57 | 16 | 57 |
| EG006 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. | 0 | 217 | 1 | 217 | 50 | 217 |
| EG007 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. | 0 | 208 | 0 | 208 | 45 | 208 |
| EG008 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. | 0 | 223 | 1 | 223 | 31 | 223 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Chills | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Pyrexia | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Drug-induced liver injury | Hepatobiliary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Anaphylactic reaction | Immune system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Diarrhoea infectious | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Oral herpes | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Pneumonia | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Enteritis infectious | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Ankle fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Meniscus injury | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Muscle injury | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Tendon injury | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Nephrolithiasis | Renal and urinary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Ureterolithiasis | Renal and urinary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Urinary tract obstruction | Renal and urinary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Breast mass | Reproductive system and breast disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Uterine haemorrhage | Reproductive system and breast disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Night sweats | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Lymphadenitis | Blood and lymphatic system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Lymphadenopathy | Blood and lymphatic system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Lymphopenia | Blood and lymphatic system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Microcytic anaemia | Blood and lymphatic system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Thrombocytosis | Blood and lymphatic system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Arrhythmia | Cardiac disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Atrioventricular block first degree | Cardiac disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Bradycardia | Cardiac disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Defect conduction intraventricular | Cardiac disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Palpitations | Cardiac disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Sinus bradycardia | Cardiac disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Ventricular extrasystoles | Cardiac disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Dermoid cyst | Congenital, familial and genetic disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| Congenital lacrimal passage anomaly | Congenital, familial and genetic disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
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| External ear inflammation | Ear and labyrinth disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Vertigo positional | Ear and labyrinth disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Asthenopia | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Blepharitis | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Conjunctival haemorrhage | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Conjunctival irritation | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Conjunctivitis allergic | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dry eye | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Eye irritation | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Eye pain | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Eye pruritus | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Eyelid oedema | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Eyelid pain | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Eyelids pruritus | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Lacrimation increased | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Noninfective conjunctivitis | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Ocular discomfort | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Ocular hyperaemia | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Presbyopia | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Swelling of eyelid | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Vision blurred | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Eczema eyelids | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Eyelid cyst | Eye disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Anal pruritus | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dental caries | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Faeces soft | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Food poisoning | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Frequent bowel movements | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Gingival pain | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Inguinal hernia | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Noninfective gingivitis | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Tooth impacted | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Toothache | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Gastritis erosive | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Asthenia | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Chest pain | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Chills | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Cyst | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Fatigue | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Feeling abnormal | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Feeling cold | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Feeling hot | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Inflammation | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Influenza like illness | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Injection site erythema | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Injection site oedema | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Injection site pain | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Injection site swelling | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Mass | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Malaise | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Medical device site rash | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Oedema peripheral | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pain | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Peripheral swelling | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pyrexia | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Swelling | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Swelling face | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Therapeutic response unexpected | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Xerosis | General disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Gallbladder polyp | Hepatobiliary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Biliary colic | Hepatobiliary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hepatic function abnormal | Hepatobiliary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hepatic lesion | Hepatobiliary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Liver disorder | Hepatobiliary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Allergy to chemicals | Immune system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Food allergy | Immune system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hypersensitivity | Immune system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Seasonal allergy | Immune system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Abscess limb | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Bacterial vaginosis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Body tinea | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Bronchitis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Cellulitis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Conjunctivitis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Conjunctivitis bacterial | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Cystitis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dermatophytosis of nail | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Ear infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Eczema herpeticum | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Eczema infected | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Epstein-Barr virus infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Erysipelas | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Folliculitis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Fungal infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Fungal skin infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Furuncle | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Gastroenteritis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Gastrointestinal infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Gingivitis | Infections and infestations | Non-systematic Assessment |
| ||
| Hand-foot-and-mouth disease | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Herpes dermatitis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Herpes simplex | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Herpes virus infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Herpes zoster | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hordeolum | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Impetigo | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Influenza | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Kaposi's varicelliform eruption | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Laryngitis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Lower respiratory tract infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Malassezia infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Molluscum contagiosum | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Ophthalmic herpes simplex | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Ophthalmic herpes zoster | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Oral herpes | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Otitis media | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Paronychia | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Perichondritis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pharyngitis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pharyngitis bacterial | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pharyngotonsillitis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pulpitis dental | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pustule | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Rash pustular | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Respiratory tract infection viral | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Rhinitis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Sinusitis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Sinusitis bacterial | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Skin bacterial infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Skin candida | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Skin infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Staphylococcal skin infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Subcutaneous abscess | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Tinea pedis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Tinea versicolour | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Tonsillitis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Tooth abscess | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Tooth infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Ureaplasma infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Urinary tract infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Urinary tract infection bacterial | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Viral infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Viral upper respiratory tract infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Vulvovaginal mycotic infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Wound infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Asymptomatic bacteriuria | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Bronchitis bacterial | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Bronchitis viral | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Gastrointestinal viral infection | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Genital herpes simplex | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Nasal herpes | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pneumonia bacterial | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Vulvovaginal candidiasis | Infections and infestations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Animal bite | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Eye injury | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Foot fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Joint injury | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Ligament sprain | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Limb injury | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Medication error | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Muscle strain | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Road traffic accident | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Scapula fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Skin abrasion | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Skin laceration | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Tooth fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Arthropod bite | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Epicondylitis | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Humerus fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Wound | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Activated partial thromboplastin time prolonged | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Biopsy endometrium | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Blood bilirubin increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Blood cholesterol increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Blood creatine phosphokinase increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Blood creatinine increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Blood lactate dehydrogenase increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Body temperature increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| C-reactive protein increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Cardiac murmur | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Ejection fraction decreased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Electrocardiogram QT prolonged | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Electrocardiogram T wave amplitude increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Haematocrit decreased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Haemoglobin decreased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Lipids increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Liver function test increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Natural killer cell count decreased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Red blood cell count decreased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| T-lymphocyte count decreased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Transaminases increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Weight increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Blood pressure increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Blood urea increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Gamma-glutamyltransferase increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Liver function test abnormal | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Urine analysis abnormal | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Increased appetite | Metabolism and nutrition disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Obesity | Metabolism and nutrition disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Mandibular mass | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dizziness | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dysaesthesia | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| External compression headache | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Headache | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hypertonia | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Migraine | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Nerve compression | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Neuralgia | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Neuropathy peripheral | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Paraesthesia | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Parosmia | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Presyncope | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Somnolence | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Tension headache | Nervous system disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Anxiety | Psychiatric disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Apathy | Psychiatric disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Depression | Psychiatric disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Depression suicidal | Psychiatric disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Insomnia | Psychiatric disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Irritability | Psychiatric disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Libido decreased | Psychiatric disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Mood swings | Psychiatric disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Schizophrenia | Psychiatric disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dysuria | Renal and urinary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pollakiuria | Renal and urinary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Polyuria | Renal and urinary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Calculus urinary | Renal and urinary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Haematuria | Renal and urinary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Leukocyturia | Renal and urinary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Urinary tract inflammation | Renal and urinary disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Erectile dysfunction | Reproductive system and breast disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hypomenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Menorrhagia | Reproductive system and breast disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Metrorrhagia | Reproductive system and breast disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Ovarian cyst | Reproductive system and breast disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Ovarian disorder | Reproductive system and breast disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Balanoposthitis | Reproductive system and breast disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Prostatitis | Reproductive system and breast disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Nasal crusting | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Snoring | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Acne | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Alopecia areata | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Angioedema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dyshidrotic eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Keratosis pilaris | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Nail bed disorder | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Nail fold inflammation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Neurodermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Neutrophilic dermatosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Pruritus allergic | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Rash papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Seborrhoea | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Victim of crime | Social circumstances | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Rotator cuff repair | Surgical and medical procedures | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Tooth extraction | Surgical and medical procedures | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Aortic stenosis | Vascular disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Essential hypertension | Vascular disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hot flush | Vascular disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Hypertension | Vascular disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
| |
| Eosinophil percentage increased | Investigations | Non-systematic Assessment | MedDRA v22.1 was used for coding events till Week 16 and MedDRA v23.0 was used for coding events post Week 16. |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2020 | Dec 21, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D012871 | Skin Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D017443 | Skin Diseases, Eczematous |
| D006967 | Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| C000634427 | abrocitinib |
| C582203 | dupilumab |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Pregnancy |
|
| Protocol Deviation |
|
| Withdrawal by Subject |
|
| Other |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Difference in percentage (PF-04965842 versus placebo) and CI for difference were calculated based on the weighted average of difference by disease severity group using the normal approximation of binomial proportions. P-value was adjusted by baseline disease severity. |
| Cochran-Mantel-Haenszel |
| <0.0001 |
| Difference in Percentage |
| 34.8 |
| 2-Sided |
| 95 |
| 26.1 |
| 43.5 |
| Superiority |
| OG001 | PF-04965842 100 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
|
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
|
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
|
| OG001 | PF-04965842 100 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
|
| OG001 | PF-04965842 100 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
| OG001 | PF-04965842 100 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
| OG001 | PF-04965842 100 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
| Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 |
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| OG002 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. |
| OG003 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| OG004 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. |
|
|
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16.
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
| PF-04965842 200 mg + Placebo Injection up to Week 16 |
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
| PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 |
Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. |
| OG003 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| OG004 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. |
|
|
| PF-04965842 100 mg + Placebo Injection up to Week 16 |
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
| Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 |
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| OG002 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. |
| OG003 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| OG004 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. |
|
|
Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. |
| OG003 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| OG004 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. |
|
|
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
| OG002 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. |
| OG003 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| OG004 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. |
|
|
| OG002 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. |
| OG003 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| OG004 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. |
|
|
Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
| PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 |
Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. |
| OG003 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| OG004 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. |
|
|
Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| OG002 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. |
| OG003 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| OG004 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. |
|
|
| OG001 | PF-04965842 100 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
| OG001 | PF-04965842 100 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
| OG001 | PF-04965842 100 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG002 | PF-04965842 200 mg + Placebo Injection up to Week 16 | Participants were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16. |
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
|
|
| OG001 | Placebo up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants who were randomized to receive oral placebo matched to PF-04965842 with subcutaneous injectable placebo matched to dupilumab till Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| OG002 | PF-04965842 100 mg + Placebo Injection up to Week 16 Then PF-04965842 100 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 100 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 100 mg tablet orally once daily post Week 16 up to Week 20. |
| OG003 | PF-04965842 200 mg + Placebo Injection up to Week 16 Then PF-04965842 200 mg Week 16 to 20 | Participants who were randomized to receive PF-04965842 200 mg tablet orally once daily with subcutaneous injectable placebo matched to dupilumab every other week from Day 1 to Week 16, received PF-04965842 200 mg tablet orally once daily post Week 16 up to Week 20. |
| OG004 | Dupilumab 300 mg + Oral Placebo up to Week 16 Then Oral Placebo Week 16 to 20 | Participants who were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16, received oral placebo matched to PF-04965842 once daily post Week 16 up to Week 20. |
|
|
| OG003 | Dupilumab 300 mg + Oral Placebo up to Week 16 | Participants were randomized to receive dupilumab 300 mg subcutaneous injection every other week with oral placebo matched to PF-04965842 once daily from Day 1 to Week 16. |
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