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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005102-38 | EudraCT Number | ||
| 1311.4 | Other Identifier | Boehringer Ingelheim |
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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This was a multinational, multicenter, randomized, double-blind, placebo controlled study with randomized withdrawal and retreatment, evaluating the safety and efficacy of risankizumab 150 mg subcutaneous (SC) in participants with moderate to severe chronic plaque psoriasis.
In Part A1, eligible participants were randomized at Baseline at a ratio of 4:1, stratified by weight and prior exposure to tumor necrosis factor antagonists to receive double-blind (DB) risankizumab 150 mg or placebo at Weeks 0 and 4. In Part A2, participants randomized at Baseline to receive DB placebo then received risankizumab 150 mg at Weeks 16 (Part A2) and at Week 28 and every 12 weeks up to 88 weeks (Part B); participants randomized to risankizumab 150 mg continued to receive risankizumab 150 mg at Week 16. Participants who received risankizumab in Part A and were nonresponders (sPGA >2) at Week 28 received risankizumab 150 mg at Week 28 and every 12 weeks up to 88 weeks (Part B). In Part B, participants who received risankizumab in Part A and were responders (sPGA ≤2) at Week 28, were rerandomized at a ratio of 1:2 to receive DB risankizumab 150 mg or placebo at Week 28 and every 12 weeks up to 88 weeks (Part B). Starting at Week 32, rerandomized participants who reached relapse (defined as sPGA ≥3) were switched to risankizumab 150 mg every 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab | Experimental | Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg by subcutaneous injection at Weeks 0 and 4 (Part A1). |
|
| Placebo | Placebo Comparator | Participants randomized at Baseline to receive double-blind (DB) placebo by subcutaneous injection at Weeks 0 and 4 (Part A1). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Risankizumab administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data. | Baseline, Week 16 |
| Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. | Week 16 |
| Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34921669 | Derived | Lebwohl MG, Soliman AM, Yang H, Wang J, Hagan K, Padilla B, Pinter A. Impact of Risankizumab on PASI90 and DLQI0/1 Duration in Moderate-to-Severe Psoriasis: A Post Hoc Analysis of Four Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2022 Feb;12(2):407-418. doi: 10.1007/s13555-021-00660-3. Epub 2021 Dec 18. | |
| 32267471 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Part A1: double-blind (DB) risankizumab or placebo (Weeks 0,4). Part A2 (Week 16) DB placebo to DB risankizumab; risankizumab continued risankizumab. Part B (Week 28) risankizumab responders rerandomized to DB risankizumab/placebo; risankizumab nonresponders continued risankizumab. Week 32: rerandomized relapsed switch risankizumab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Part A1) | Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1). |
| FG001 | Risankizumab (Part A1) | Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1). |
| FG002 | Placebo/Risankizumab Part A2/Part B | Participants randomized at Baseline to receive double-blind (DB) placebo then received DB risankizumab 150 mg at Weeks 16 (Part A2) and at Week 28 and every 12 weeks up to 88 weeks (Part B). |
| FG003 | Risankizumab/Risankizumab Part A2 | Participants randomized at Baseline to receive double-blind (DB) risankizumab then received DB risankizumab 150 mg at Weeks 16 (Part A2). |
| FG004 | Risankizumab/Placebo (Part B; Rerandomized Responders) | Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B). |
| FG005 | Risankizumab/Risankizumab (Part B; Rerandomized Responders) | Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B). |
| FG006 | Risankizumab/Risankizumab Part B (Nonresponders) | Participants who received risankizumab in Part A and were nonresponders (sPGA ≥2) at Week 28 received risankizumab 150 mg at Week 28 and every 12 weeks up to 88 weeks (Part B). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A1 |
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| Part A2 |
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| Part B |
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Intent to Treat (ITT) Population in Part A1 (ITT_A1): All participants who were randomized at Baseline
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Part A1) | Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1). |
| BG001 | Risankizumab (Part A1) | Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving 90% Improvement Psoriasis Area and Severity Index (PASI) Score (PASI90) From Baseline to Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. Non-responder imputation (NRI) was used for missing data. | Intent to treat (ITT) Population in Part A1(ITT_A1): all participants who were randomized at Baseline. | Posted | Number | percentage of participants | Baseline, Week 16 |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 103 weeks).
TEAEs and TESAEs: defined as any adverse event (AE) or serious adverse event (SAE) with onset or worsening reported by participant from time to first dose of study drug administered within 15 weeks following discontinuation of risankizumab administration or, for AEs presented by study Part, from first dose in the study Part until prior to first dose in the subsequent study Part (Part A1=from Week 0 until prior to Week 16 dose; Part B=from Week 28 to 15 weeks after last dose at [up to Week 103]).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Part A1) | All participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA version 21 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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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 | Oct 11, 2016 | Apr 12, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 12, 2017 | Apr 12, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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| Placebo | Drug | Placebo for risankizumab administered by subcutaneous injection |
|
| Week 16 |
| Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data. | Week 16 |
| Percentage of Participants Achieving an sPGA Score of Clear at Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. | Week 16 |
| Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. NRI was used for missing data. | Week 16 |
| Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. | Week 104 |
| Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data. | Week 52 |
| Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data. | Week 52 |
| Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data. | Week 52 |
| Blauvelt A, Leonardi CL, Gooderham M, Papp KA, Philipp S, Wu JJ, Igarashi A, Flack M, Geng Z, Wu T, Camez A, Williams D, Langley RG. Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2020 Jun 1;156(6):649-658. doi: 10.1001/jamadermatol.2020.0723. |
| 31667790 | Derived | Suleiman AA, Khatri A, Oberoi RK, Othman AA. Exposure-Response Relationships for the Efficacy and Safety of Risankizumab in Japanese Subjects with Psoriasis. Clin Pharmacokinet. 2020 May;59(5):575-589. doi: 10.1007/s40262-019-00829-2. |
| 31054118 | Derived | Suleiman AA, Minocha M, Khatri A, Pang Y, Othman AA. Population Pharmacokinetics of Risankizumab in Healthy Volunteers and Subjects with Moderate to Severe Plaque Psoriasis: Integrated Analyses of Phase I-III Clinical Trials. Clin Pharmacokinet. 2019 Oct;58(10):1309-1321. doi: 10.1007/s40262-019-00759-z. |
| Adverse Event |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| OG000 | Placebo (Part A1) | Participants randomized at Baseline to receive double-blind (DB) placebo at Weeks 0 and 4 (Part A1). |
| OG001 | Risankizumab (Part A1) | Participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1). |
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| Primary | Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. | ITT Population in Part A1(ITT_A1) | Posted | Number | percentage of participants | Week 16 |
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| Primary | Percentage of Participants Achieving sPGA Score of Clear or Almost Clear at Week 52 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. | ITT Population in Part B for re-randomized participants (ITT_B_R): All participants who were randomized to Arm 1 at Baseline and re randomized at Week 28. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data. | ITT Population in Part A1 (ITT_A1) | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 16 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data. | ITT Population in Part A1 (ITT_A1) | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Achieving an sPGA Score of Clear at Week 16 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. | ITT Population in Part A1 (ITT_A1) | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on patient's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on patient's life. The higher the score, the more the quality of life is impaired. NRI was used for missing data. | ITT Population in Part A1 (ITT_A1) | Posted | Number | percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Achieving an sPGA Score of Clear or Almost Clear at Week 104 | The sPGA is an assessment by the investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale ranging from 0 (none) to 4 (severe). The sPGA ranges from 0 to 4, and is calculated as Clear (0) = 0 for all three; Almost clear (1) = mean >0, <1.5; Mild (2) = mean ≥1.5, <2.5; Moderate (3) = mean ≥2.5, <3.5; and Severe (4) = mean ≥3.5. NRI was used for missing data. | ITT Population in Part B for re-randomized participants (ITT_B_R) | Posted | Number | percentage of participants | Week 104 |
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| Secondary | Percentage of Participants Achieving 75% Improvement in PASI Score (PASI75) at Week 52 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI75 is defined as at least a 75% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data. | ITT Population in Part B for re-randomized participants (ITT_B_R) | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants Achieving 90% Improvement in PASI Score (PASI90) at Week 52 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data. | ITT Population in Part B for re-randomized participants (ITT_B_R) | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants Achieving 100% Improvement in PASI Score (PASI100) at Week 52 | PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI100 is defined as a 100% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline * 100. NRI was used for missing data. | ITT Population in Part B for re-randomized participants (ITT_B_R) | Posted | Number | percentage of participants | Week 52 |
|
|
|
|
| 0 |
| 100 |
| 8 |
| 100 |
| 17 |
| 100 |
| EG001 | Risankizumab (Part A1) | All participants randomized at Baseline to receive double-blind (DB) risankizumab 150 mg at Weeks 0 and 4 (Part A1). | 0 | 407 | 8 | 407 | 52 | 407 |
| EG002 | Risankizumab/Placebo (Part B; Rerandomized Responders) | Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive placebo at Week 28 and every 12 weeks up to Week 88 (Part B). | 0 | 225 | 17 | 225 | 92 | 225 |
| EG003 | Risankizumab/Risankizumab (Part B; Rerandomized Responders) | Participants who received risankizumab in Part A and were responders (sPGA 0 or 1) at Week 28, and rerandomized to receive risankizumab 150 mg at Week 28 and every 12 weeks up to Week 88 (Part B). | 2 | 111 | 13 | 111 | 52 | 111 |
| EG004 | Any Risankizumab | Participants who received at least one dose of risankizumab during the study. | 4 | 500 | 55 | 500 | 242 | 500 |
| Acute myocardial infarction | Cardiac disorders | MedDRA version 21 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA version 21 | Systematic Assessment |
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| Aortic valve disease mixed | Cardiac disorders | MedDRA version 21 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA version 21 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA version 21 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA version 21 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA version 21 | Systematic Assessment |
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| Intracardiac thrombus | Cardiac disorders | MedDRA version 21 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA version 21 | Systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | MedDRA version 21 | Systematic Assessment |
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| Benign familial pemphigus | Congenital, familial and genetic disorders | MedDRA version 21 | Systematic Assessment |
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| Huntington's disease | Congenital, familial and genetic disorders | MedDRA version 21 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA version 21 | Systematic Assessment |
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| Amaurosis fugax | Eye disorders | MedDRA version 21 | Systematic Assessment |
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| Diabetic retinopathy | Eye disorders | MedDRA version 21 | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA version 21 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 21 | Systematic Assessment |
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| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA version 21 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA version 21 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA version 21 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 21 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 21 | Systematic Assessment |
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| Death | General disorders | MedDRA version 21 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA version 21 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 21 | Systematic Assessment |
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| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA version 21 | Systematic Assessment |
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| Liver injury | Hepatobiliary disorders | MedDRA version 21 | Systematic Assessment |
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| Abdominal abscess | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Abscess neck | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Meningitis bacterial | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Periorbital cellulitis | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Burns second degree | Injury, poisoning and procedural complications | MedDRA version 21 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA version 21 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 21 | Systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA version 21 | Systematic Assessment |
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| Incisional hernia | Injury, poisoning and procedural complications | MedDRA version 21 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA version 21 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA version 21 | Systematic Assessment |
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| Open globe injury | Injury, poisoning and procedural complications | MedDRA version 21 | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 21 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA version 21 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 21 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 21 | Systematic Assessment |
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| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA version 21 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA version 21 | Systematic Assessment |
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| Gouty tophus | Musculoskeletal and connective tissue disorders | MedDRA version 21 | Systematic Assessment |
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| Jaw cyst | Musculoskeletal and connective tissue disorders | MedDRA version 21 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 21 | Systematic Assessment |
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| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA version 21 | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 21 | Systematic Assessment |
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| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21 | Systematic Assessment |
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| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21 | Systematic Assessment |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21 | Systematic Assessment |
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| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21 | Systematic Assessment |
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| Intestinal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21 | Systematic Assessment |
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| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21 | Systematic Assessment |
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| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21 | Systematic Assessment |
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| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21 | Systematic Assessment |
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| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21 | Systematic Assessment |
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| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 21 | Systematic Assessment |
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| Basal ganglia infarction | Nervous system disorders | MedDRA version 21 | Systematic Assessment |
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| Carotid artery occlusion | Nervous system disorders | MedDRA version 21 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA version 21 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA version 21 | Systematic Assessment |
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| Dementia | Nervous system disorders | MedDRA version 21 | Systematic Assessment |
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| Encephalitis autoimmune | Nervous system disorders | MedDRA version 21 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA version 21 | Systematic Assessment |
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| Hemiplegia | Nervous system disorders | MedDRA version 21 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA version 21 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA version 21 | Systematic Assessment |
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| Tension headache | Nervous system disorders | MedDRA version 21 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA version 21 | Systematic Assessment |
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| Alcoholism | Psychiatric disorders | MedDRA version 21 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA version 21 | Systematic Assessment |
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| Delirium tremens | Psychiatric disorders | MedDRA version 21 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 21 | Systematic Assessment |
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| Somatic symptom disorder | Psychiatric disorders | MedDRA version 21 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA version 21 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 21 | Systematic Assessment |
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| Cervical dysplasia | Reproductive system and breast disorders | MedDRA version 21 | Systematic Assessment |
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| Menometrorrhagia | Reproductive system and breast disorders | MedDRA version 21 | Systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | MedDRA version 21 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 21 | Systematic Assessment |
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| Chylothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 21 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 21 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 21 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version 21 | Systematic Assessment |
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| Alcohol detoxification | Surgical and medical procedures | MedDRA version 21 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA version 21 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 21 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 21 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 21 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 21 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA version 21 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.