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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022384-35 | EudraCT Number |
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This study was terminated due to the lack of efficacy of GSK1605786A in Crohn's disease based on the results of Study CCX114151.
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An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.
This is a multi-centre, open-label extension study to assess the long-term safety, tolerability and effectiveness of GSK1605786A in subjects with Crohn's disease. Subjects will enter the study via one of three routes:
The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and disability.
It is estimated that approximately 800 subjects will be enrolled in total. All subjects will enter the study at baseline (Week 0) and commence oral treatment with GSK1605786A 500 mg twice daily.
The study will be conducted for 108 weeks. Once the results of the induction study CCX114151 are known, the risk-to-benefit ratio will be re-assessed and the study duration may be amended.
Study assessments for Crohn's disease will be performed every 12 weeks through Week 108. At week 12, the investigator will make a determination of whether the subject is receiving clinical benefit, and subjects who are not receiving clinical benefit must be withdrawn. More frequent blood draws are required for liver function testing only; every 2 weeks for the first 12 weeks, then every 4 weeks up to Week 52, and every 12 weeks after Week 60 for the duration of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1605786A | Experimental | 500 milligrams twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1605786A | Drug | 500 milligrams twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety population consisted of all participants who enrolled in the study except those who did not take >=1 dose of investigational product. | Up to Week 112 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period | The SBP and DBP values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Baseline value was recorded at Week 0. Change from Baseline measurements in SBP and DBP were assessed at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Little Rock | Arizona | 72205 | United States | ||
| GSK Investigational Site |
All participants entered the study at a Baseline visit, Week 0, and received GSK1605786A 500 milligrams (mg), twice daily (BID) for 216 weeks.
Participants were eligible to enter the study if they completed the placebo-controlled induction study CCX114151; completed the maintenance study CCX114157 at Week 52; or withdrew from the maintenance study CCX114157. A total of such 800 participants were planned to be enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK1605786A | Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline (Week 0) and up to Week 112 |
| Change From Baseline (Week 0) in Heart Rate (HR) Over Period | The HR values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Change from Baseline in HR was assessed at Week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. | Baseline (week 0) and up to Week 112 |
| Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters | Hematology parameters measured included platelets, neutrophils (NL), lymphocytes, monocytes, eosinophils, basophils, hematocrit, band cells, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count, and segmented (seg) NL. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated hematology parameters data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, shift to high) until 4 weeks post treatment are presented. | Baseline (Week 0) and up to Week 112 |
| Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters | Clinical chemistry parameters included platelets, total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma-glutamyl transferase, total bilirubin (TB), direct bilirubin (DB), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN)/urea, creatinine, uric acid, bicarbonate, lactate dehydrogenase, cholesterol, alkaline phosphatase (ALP), gamma glutamyl transferases (GGT), and creatine kinase. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated clinical chemistry parameters' data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, or shift to high) until 4 weeks post-treatment are presented. | Baseline (Week 0) and up to Week 112 |
| Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT) | Changes in Baseline in ALP, ALT, AST, and GGT were assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline. | Baseline (Week 0) and up to Week 112 |
| Change From Baseline (Week 0) in Total Bilirubin | Changes from Baseline (Week 0) in total bilirubin (TB) was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline. | Baseline (Week 0) and up to Week 112 |
| Change From Baseline (Week 0) in Albumin | Change from Baseline in albumin was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post treatment. The last value on or prior to the treatment start date (Week 0) was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline. | Baseline (Week 0) and up to Week 112 |
| Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value | QTc is the corrected QT interval as measured by the electrocardiogram (ECG). ECG parameters including the change from Baseline in the QTc interval values QTcF and QTcB were summarised. The QTcF is Fridericia's formula and defined as the QT interval/cubed root of the R-R interval. The QTcB is the Bazett's formula defined as the QT/squared root of the R-R interval. The number of participants with change from Baseline in the QTcF and QTcB intervals of >30, 30 to <60 and >=60 milliseconds were assessed at Week 24, 48, 72, 108, and Week 112. The last value on or prior to the treatment start date was considered the Baseline value (Week 0). Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. | Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment) |
| Change From Baseline (Week 0) in Crohn's Disease Activity Index (CDAI) Score Over 108 Weeks | The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant,investigator entries, standardized weight determination, and Hematocrit values received from the central laboratory. The Baseline CDAI score was recorded pre-dose on Week 0. Change from Baseline is the value at indicated time point minus the Baseline value. Remissions are defined as participants with CDAI score of < 150 points. No imputation for missing data was performed. The assessment was based on questionnaire like number of liquid stool in past 7 days, abdominal pain, other symptoms, antidiarrheal use, abdominal mass, anemia, and body weight. The total score is summation of all individual sub-scores. CDAI scoring scale ranges from 0-500 and a score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Baseline (Week 0) and up to 108 weeks |
| Percentage of Participants in Clinical Remission (CDAI Score Less Than 150) for All Participants, for Participants in Remission at Baseline (Week 0), and for Participants Not in Remission at Baseline Over 108 Weeks | The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product is taken. The CDAI score was measured over 108 weeks although it was planned to be measured till 112 weeks. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed. Combined data for participants with remission at Baseline and without remission at Baseline has been presented. | Baseline (Week 0) and up to 108 weeks |
| Percentage of Participants Achieving Response (CDAI Decrease of at Least 100 Points From Baseline ([Week 0] of Prior Induction Study) in the Sub-population of Non-responders at Study Entry Over 112 Weeks | The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product was taken. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed. | Baseline (Week 0) and up to 112 weeks |
| Change From Baseline (Week 0) in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form Health Survey (SF-36) Version 2, EuroQol 5 Dimensional (EQ-5D), Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and Disability Over 112 Weeks | IBDQ, SF-36, EQ-5D, WPAI-CD, and disability scores were all health outcome related scores that were based on assessment of participants based on different questionnaire. Each scoring scale had different range and participants were planned to be rated separately based on each scale. | Baseline (Week 0) and up to 112 weeks |
| Tucson |
| Arizona |
| 85712 |
| United States |
| GSK Investigational Site | Anaheim | California | 92801 | United States |
| GSK Investigational Site | La Jolla | California | 92093 | United States |
| GSK Investigational Site | San Diego | California | 92103 | United States |
| GSK Investigational Site | San Francisco | California | 94115 | United States |
| GSK Investigational Site | Aurora | Colorado | 80045 | United States |
| GSK Investigational Site | Lakewood | Colorado | 80215 | United States |
| GSK Investigational Site | Littleton | Colorado | 80120 | United States |
| GSK Investigational Site | Hamden | Connecticut | 06518 | United States |
| GSK Investigational Site | New Haven | Connecticut | 06510 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32256-6004 | United States |
| GSK Investigational Site | Port Orange | Florida | 32127 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342-5006 | United States |
| GSK Investigational Site | Suwanee | Georgia | 30024 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46237 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40536-0298 | United States |
| GSK Investigational Site | Hammond | Louisiana | 70403 | United States |
| GSK Investigational Site | Monroe | Louisiana | 71201 | United States |
| GSK Investigational Site | Chevy Chase | Maryland | 20815 | United States |
| GSK Investigational Site | Towson | Maryland | 21204 | United States |
| GSK Investigational Site | Towson | Maryland | 21286 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02114 | United States |
| GSK Investigational Site | Ann Arbor | Michigan | 48109-5682 | United States |
| GSK Investigational Site | Chesterfield | Michigan | 48047 | United States |
| GSK Investigational Site | Troy | Michigan | 48098 | United States |
| GSK Investigational Site | Rochester | Minnesota | 55905 | United States |
| GSK Investigational Site | Lee's Summit | Missouri | 64064 | United States |
| GSK Investigational Site | Mexico | Missouri | 65265-3726 | United States |
| GSK Investigational Site | Brooklyn | New York | 11206 | United States |
| GSK Investigational Site | East Setauket | New York | 11733-9292 | United States |
| GSK Investigational Site | Great Neck | New York | 11021 | United States |
| GSK Investigational Site | Lake Success | New York | 11042 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599-7080 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | United States |
| GSK Investigational Site | Durham | North Carolina | 27710 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27612 | United States |
| GSK Investigational Site | Columbus | Ohio | 43215 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74135 | United States |
| GSK Investigational Site | Portland | Oregon | 97225 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15212 | United States |
| GSK Investigational Site | Germantown | Tennessee | 38138 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37212-1610 | United States |
| GSK Investigational Site | Ogden | Utah | 84405 | United States |
| GSK Investigational Site | Christiansburg | Virginia | 24073 | United States |
| GSK Investigational Site | Danville | Virginia | 24541 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23502 | United States |
| GSK Investigational Site | Richmond | Virginia | 23249 | United States |
| GSK Investigational Site | Seattle | Washington | 98101 | United States |
| GSK Investigational Site | Seattle | Washington | 98195 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | United States |
| GSK Investigational Site | Bankstown | New South Wales | 2200 | Australia |
| GSK Investigational Site | Hersten | Queensland | 4029 | Australia |
| GSK Investigational Site | Adelaide | South Australia | 5000 | Australia |
| GSK Investigational Site | Kurralta Park | South Australia | 5037 | Australia |
| GSK Investigational Site | Box Hill | Victoria | 3128 | Australia |
| GSK Investigational Site | Fitzroy | Victoria | 3065 | Australia |
| GSK Investigational Site | Prahran | Victoria | 3181 | Australia |
| GSK Investigational Site | Fremantle | Western Australia | 6160 | Australia |
| GSK Investigational Site | Hall in Tirol | 6060 | Austria |
| GSK Investigational Site | Linz | A-4021 | Austria |
| GSK Investigational Site | Oberpullendorf | 7350 | Austria |
| GSK Investigational Site | St.Veit/Glan | 9300 | Austria |
| GSK Investigational Site | Vienna | 1030 | Austria |
| GSK Investigational Site | Vienna | 1050 | Austria |
| GSK Investigational Site | Vienna | 1090 | Austria |
| GSK Investigational Site | Bonheiden | 2820 | Belgium |
| GSK Investigational Site | Brussels | 1000 | Belgium |
| GSK Investigational Site | Brussels | 1200 | Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Kortrijk | 8500 | Belgium |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | Roeselare | 8800 | Belgium |
| GSK Investigational Site | Plovdiv | 4002 | Bulgaria |
| GSK Investigational Site | Sofia | 1407 | Bulgaria |
| GSK Investigational Site | Sofia | 1431 | Bulgaria |
| GSK Investigational Site | Sofia | 1527 | Bulgaria |
| GSK Investigational Site | Varna | 9010 | Bulgaria |
| GSK Investigational Site | Calgary | Alberta | T2N 4Z6 | Canada |
| GSK Investigational Site | Edmonton | Alberta | T6G 2X8 | Canada |
| GSK Investigational Site | Abbotsford British Columbia | British Columbia | V2S 3N5 | Canada |
| GSK Investigational Site | Vancouver | British Columbia | V6Z 2K5 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R3A 1R9 | Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8N 4A6 | Canada |
| GSK Investigational Site | Kingston | Ontario | K7L 5G2 | Canada |
| GSK Investigational Site | London | Ontario | N6A 5A5 | Canada |
| GSK Investigational Site | London | Ontario | N6A 5W9 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1H 1A2 | Canada |
| GSK Investigational Site | Montreal | Quebec | H3A 1A1 | Canada |
| GSK Investigational Site | Montreal | Quebec | H3T 1E2 | Canada |
| GSK Investigational Site | Québec | Quebec | G1S 4L8 | Canada |
| GSK Investigational Site | Québec | Quebec | G3K 2P8 | Canada |
| GSK Investigational Site | Viña del Mar | 2520012 | Chile |
| GSK Investigational Site | Hradec Králové | 500 12 | Czechia |
| GSK Investigational Site | Olomouc | 77520 | Czechia |
| GSK Investigational Site | Ostrava - Vitkovice | 70384 | Czechia |
| GSK Investigational Site | Prague | 100 34 | Czechia |
| GSK Investigational Site | Prague | 140 21 | Czechia |
| GSK Investigational Site | Prague | 17004 | Czechia |
| GSK Investigational Site | Prague | 190 61 | Czechia |
| GSK Investigational Site | Aalborg | 9000 | Denmark |
| GSK Investigational Site | Aarhus | 8000 | Denmark |
| GSK Investigational Site | Herlev | 2730 | Denmark |
| GSK Investigational Site | Hvidovre | 2605 | Denmark |
| GSK Investigational Site | Odense | 5000 | Denmark |
| GSK Investigational Site | Tallinn | 10617 | Estonia |
| GSK Investigational Site | Tallinn | EE-10138 | Estonia |
| GSK Investigational Site | Tartu | 51014 | Estonia |
| GSK Investigational Site | Clichy | 92118 | France |
| GSK Investigational Site | Lille | 59037 | France |
| GSK Investigational Site | Nantes | 44093 | France |
| GSK Investigational Site | Nice | 06202 | France |
| GSK Investigational Site | Paris | 75475 | France |
| GSK Investigational Site | Pessac | 33604 | France |
| GSK Investigational Site | Saint-Priest-en-Jarez | 42270 | France |
| GSK Investigational Site | Vandœuvre-lès-Nancy | 54511 | France |
| GSK Investigational Site | Ulm | Baden-Wurttemberg | 89081 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60590 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| GSK Investigational Site | Minden | North Rhine-Westphalia | 32423 | Germany |
| GSK Investigational Site | Berlin | 10117 | Germany |
| GSK Investigational Site | Berlin | 13353 | Germany |
| GSK Investigational Site | Hamburg | 20148 | Germany |
| GSK Investigational Site | Hamburg | 22559 | Germany |
| GSK Investigational Site | Hong Kong | Hong Kong |
| GSK Investigational Site | Shatin, New Territories | Hong Kong |
| GSK Investigational Site | Békéscsaba | 5600 | Hungary |
| GSK Investigational Site | Budapest | 1062 | Hungary |
| GSK Investigational Site | Budapest | 1083 | Hungary |
| GSK Investigational Site | Budapest | 1136 | Hungary |
| GSK Investigational Site | Debrecen | 4025 | Hungary |
| GSK Investigational Site | Mosonmagyaróvár | 9200 | Hungary |
| GSK Investigational Site | Szekszárd | 7100 | Hungary |
| GSK Investigational Site | Vác | 2600 | Hungary |
| GSK Investigational Site | Afula | 18101 | Israel |
| GSK Investigational Site | Beersheba | 84101 | Israel |
| GSK Investigational Site | Haifa | 31096 | Israel |
| GSK Investigational Site | Holon | 58100 | Israel |
| GSK Investigational Site | Jerusalem | 91031 | Israel |
| GSK Investigational Site | Jerusalem | 91120 | Israel |
| GSK Investigational Site | Kfar Saba | 44281 | Israel |
| GSK Investigational Site | Petah Tikva | 49100 | Israel |
| GSK Investigational Site | Ramat Gan | 52621 | Israel |
| GSK Investigational Site | Tel Aviv | 64239 | Israel |
| GSK Investigational Site | Ẕerifin | 70300 | Israel |
| GSK Investigational Site | Genoa | Liguria | 16132 | Italy |
| GSK Investigational Site | Palermo | Sicily | 90127 | Italy |
| GSK Investigational Site | Modena | 41100 | Italy |
| GSK Investigational Site | Roma | 00152 | Italy |
| GSK Investigational Site | Aichi | 460-0012 | Japan |
| GSK Investigational Site | Chiba | 285-8741 | Japan |
| GSK Investigational Site | Fukuoka | 812-8582 | Japan |
| GSK Investigational Site | Fukuoka | 818-8502 | Japan |
| GSK Investigational Site | Hiroshima | 720-8520 | Japan |
| GSK Investigational Site | Hokkaido | 060-0033 | Japan |
| GSK Investigational Site | Hyōgo | 663-8501 | Japan |
| GSK Investigational Site | Kagoshima | 892-0846 | Japan |
| GSK Investigational Site | Kagoshima | 892-8512 | Japan |
| GSK Investigational Site | Miyagi | 981-3213 | Japan |
| GSK Investigational Site | Osaka | 530-0011 | Japan |
| GSK Investigational Site | Osaka | 545-8586 | Japan |
| GSK Investigational Site | Tokyo | 160-8582 | Japan |
| GSK Investigational Site | Tokyo | 169-0073 | Japan |
| GSK Investigational Site | Dunedin | 9054 | New Zealand |
| GSK Investigational Site | Lower Hutt | 6007 | New Zealand |
| GSK Investigational Site | Otahuhu, Auckland | 2025 | New Zealand |
| GSK Investigational Site | Tauranga | 3143 | New Zealand |
| GSK Investigational Site | Bydgoszcz | 85-168 | Poland |
| GSK Investigational Site | Bydgoszcz | 85-681 | Poland |
| GSK Investigational Site | Lublin | 20-607 | Poland |
| GSK Investigational Site | Sopot | 81-756 | Poland |
| GSK Investigational Site | Torun | 87-100 | Poland |
| GSK Investigational Site | Wroclaw | 53-333 | Poland |
| GSK Investigational Site | Lisbon | 1649-035 | Portugal |
| GSK Investigational Site | Lisbon | 1769-001 | Portugal |
| GSK Investigational Site | Porto | 4099-001 | Portugal |
| GSK Investigational Site | Viseu | 3504-509 | Portugal |
| GSK Investigational Site | Kazan' | 420064 | Russia |
| GSK Investigational Site | Lipetsk | 398055 | Russia |
| GSK Investigational Site | Moscow | 129110 | Russia |
| GSK Investigational Site | Nizhny Novgorod | 603126 | Russia |
| GSK Investigational Site | Rostov-on-Don | 344091 | Russia |
| GSK Investigational Site | Saint Petersburg | 196247 | Russia |
| GSK Investigational Site | Saint Petersburg | 197047 | Russia |
| GSK Investigational Site | Samara | 443011 | Russia |
| GSK Investigational Site | Tomsk | 634063 | Russia |
| GSK Investigational Site | Bratislava | 831 04 | Slovakia |
| GSK Investigational Site | Bratislava | 851 01 | Slovakia |
| GSK Investigational Site | Bratislava | 851 07 | Slovakia |
| GSK Investigational Site | Nitra | 949 01 | Slovakia |
| GSK Investigational Site | Nové Mesto nad Váhom | 915 01 | Slovakia |
| GSK Investigational Site | Prešov | 080 01 | Slovakia |
| GSK Investigational Site | Trnava | 917 02 | Slovakia |
| GSK Investigational Site | Bellville | 7530 | South Africa |
| GSK Investigational Site | Claremont | 7708 | South Africa |
| GSK Investigational Site | Observatory | 7925 | South Africa |
| GSK Investigational Site | Parktown | 2192 | South Africa |
| GSK Investigational Site | Busan | South Korea |
| GSK Investigational Site | Daegu | 705-717 | South Korea |
| GSK Investigational Site | Seoul | 120-752 | South Korea |
| GSK Investigational Site | Seoul | 130702 | South Korea |
| GSK Investigational Site | Seoul | 135710 | South Korea |
| GSK Investigational Site | Seoul | 138-736 | South Korea |
| GSK Investigational Site | Wŏnju | 220701 | South Korea |
| GSK Investigational Site | Badalona | 08916 | Spain |
| GSK Investigational Site | Elche | 03293 | Spain |
| GSK Investigational Site | Fuenlabrada (Madrid) | 28942 | Spain |
| GSK Investigational Site | Madrid | 28006 | Spain |
| GSK Investigational Site | Madrid | 28007 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28046 | Spain |
| GSK Investigational Site | Marbella | 29600 | Spain |
| GSK Investigational Site | Sabadell (Barcelona) | 08208 | Spain |
| GSK Investigational Site | Santander | 39008 | Spain |
| GSK Investigational Site | Lund | SE-221 85 | Sweden |
| GSK Investigational Site | Stockholm | SE-171 76 | Sweden |
| GSK Investigational Site | Stockholm | SE-182 88 | Sweden |
| GSK Investigational Site | Bern | 3004 | Switzerland |
| GSK Investigational Site | Zurich | 8091 | Switzerland |
| GSK Investigational Site | Taichung | 40705 | Taiwan |
| GSK Investigational Site | Ankara | 06100 | Turkey (Türkiye) |
| GSK Investigational Site | Chernivtsi | 58005 | Ukraine |
| GSK Investigational Site | Dnipropetrovsk | 49044 | Ukraine |
| GSK Investigational Site | Donetsk | 83003 | Ukraine |
| GSK Investigational Site | Donetsk | 83017 | Ukraine |
| GSK Investigational Site | Kharkiv | 61037 | Ukraine |
| GSK Investigational Site | Kyiv | Ukraine |
| GSK Investigational Site | Odesa | 65117 | Ukraine |
| GSK Investigational Site | Simferopol | 95017 | Ukraine |
| GSK Investigational Site | Vinnytsia | 21029 | Ukraine |
| GSK Investigational Site | Harrow | Middlesex | HA1 3UJ | United Kingdom |
| GSK Investigational Site | Birmingham | B9 5SS | United Kingdom |
| GSK Investigational Site | Bristol | BS2 8HW | United Kingdom |
| GSK Investigational Site | Edinburgh | EH4 2XU | United Kingdom |
| GSK Investigational Site | Manchester | M13 9WL | United Kingdom |
| GSK Investigational Site | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| GSK Investigational Site | Oxford | OX3 9DU | United Kingdom |
| GSK Investigational Site | Salford | M6 8HD | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
|
|
The safety population included all the participants who received at least one dose of the study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK1605786A 500 mg BID | Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | Number of Participants With Any Adverse Events (AE) and Any Serious Adverse Events (SAE) | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety population consisted of all participants who enrolled in the study except those who did not take >=1 dose of investigational product. | Safety Population | Posted | Count of Participants | Participants | Up to Week 112 |
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| Secondary | Change From Baseline (Week 0) in Systolic and Diastolic Blood Pressure (SBP and DBP) Over Period | The SBP and DBP values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Baseline value was recorded at Week 0. Change from Baseline measurements in SBP and DBP were assessed at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. | Safety Population. Only participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline (Week 0) and up to Week 112 |
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| Secondary | Change From Baseline (Week 0) in Heart Rate (HR) Over Period | The HR values were obtained as part of vital sign monitoring and measured after the participant was at rest in the supine position for at least 5 minutes. Change from Baseline in HR was assessed at Week 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 4 weeks post-treatment. The Baseline value is defined as the value at Week 0. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. | Safety Population. Only participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | beats per minute | Baseline (week 0) and up to Week 112 |
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| Secondary | Number of Participants With Shifts From Baseline (Week 0) for the Indicated Hematology Parameters | Hematology parameters measured included platelets, neutrophils (NL), lymphocytes, monocytes, eosinophils, basophils, hematocrit, band cells, red blood cell (RBC) count, hemoglobin, white blood cell (WBC) count, and segmented (seg) NL. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated hematology parameters data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, shift to high) until 4 weeks post treatment are presented. | Safety Population. Only the participants available at the time of analysis were included. | Posted | Count of Participants | Participants | Baseline (Week 0) and up to Week 112 |
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| Secondary | Number of Participants With Shifts From Baseline (Week 0) for the Indicated Clinical Chemistry Parameters | Clinical chemistry parameters included platelets, total protein, phosphorous, albumin, sodium, potassium, chloride, calcium, glucose, gamma-glutamyl transferase, total bilirubin (TB), direct bilirubin (DB), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN)/urea, creatinine, uric acid, bicarbonate, lactate dehydrogenase, cholesterol, alkaline phosphatase (ALP), gamma glutamyl transferases (GGT), and creatine kinase. The Baseline value is defined as the value obtained at Week 0. The number of participants with the indicated clinical chemistry parameters' data reference range shifts from Baseline (defined as shift to low, shift to normal or no change, or shift to high) until 4 weeks post-treatment are presented. | Safety Population. Only participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (Week 0) and up to Week 112 |
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| Secondary | Change From Baseline (Week 0) in ALT, AST, ALP, and GGT as a Function of Liver Function Test (LFT) | Changes in Baseline in ALP, ALT, AST, and GGT were assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline. | Safety Population. Only participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | International Unit per Liter (IU/L) | Baseline (Week 0) and up to Week 112 |
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| Secondary | Change From Baseline (Week 0) in Total Bilirubin | Changes from Baseline (Week 0) in total bilirubin (TB) was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post-treatment. The last value on or prior to the treatment start date was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline. | Safety Population. Only participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | micromole/Liter | Baseline (Week 0) and up to Week 112 |
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| Secondary | Change From Baseline (Week 0) in Albumin | Change from Baseline in albumin was assessed to monitor liver function. Blood samples were taken at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72, 84, 96, 108, and 4 Weeks post treatment. The last value on or prior to the treatment start date (Week 0) was considered the Baseline value. Change from Baseline was calculated as the post-Baseline value at the time point indicated minus the value at Baseline. | Safety Population. Only participants available at the specified time points were analyzed. | Posted | Mean | Standard Deviation | Grams/Liter (G/L) | Baseline (Week 0) and up to Week 112 |
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| Secondary | Number of Participants With the Indicated Change From Baseline (Week 0) in Corrected QT Interval (QTc) Value | QTc is the corrected QT interval as measured by the electrocardiogram (ECG). ECG parameters including the change from Baseline in the QTc interval values QTcF and QTcB were summarised. The QTcF is Fridericia's formula and defined as the QT interval/cubed root of the R-R interval. The QTcB is the Bazett's formula defined as the QT/squared root of the R-R interval. The number of participants with change from Baseline in the QTcF and QTcB intervals of >30, 30 to <60 and >=60 milliseconds were assessed at Week 24, 48, 72, 108, and Week 112. The last value on or prior to the treatment start date was considered the Baseline value (Week 0). Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. | Safety Population. Only participants available at the specified time points were analyzed. | Posted | Count of Participants | Participants | Baseline (week 0) and Weeks 24, 48, 72, 108, and 112 (4 weeks post treatment) |
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| Secondary | Change From Baseline (Week 0) in Crohn's Disease Activity Index (CDAI) Score Over 108 Weeks | The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant,investigator entries, standardized weight determination, and Hematocrit values received from the central laboratory. The Baseline CDAI score was recorded pre-dose on Week 0. Change from Baseline is the value at indicated time point minus the Baseline value. Remissions are defined as participants with CDAI score of < 150 points. No imputation for missing data was performed. The assessment was based on questionnaire like number of liquid stool in past 7 days, abdominal pain, other symptoms, antidiarrheal use, abdominal mass, anemia, and body weight. The total score is summation of all individual sub-scores. CDAI scoring scale ranges from 0-500 and a score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity. | Safety population. Only the participants available at the time of assessment were analyzed. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Week 0) and up to 108 weeks |
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| Secondary | Percentage of Participants in Clinical Remission (CDAI Score Less Than 150) for All Participants, for Participants in Remission at Baseline (Week 0), and for Participants Not in Remission at Baseline Over 108 Weeks | The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product is taken. The CDAI score was measured over 108 weeks although it was planned to be measured till 112 weeks. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed. Combined data for participants with remission at Baseline and without remission at Baseline has been presented. | Safety population. Only the participants available at the time of assessment were analyzed. | Posted | Number | 95% Confidence Interval | Participants | Baseline (Week 0) and up to 108 weeks |
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| Secondary | Percentage of Participants Achieving Response (CDAI Decrease of at Least 100 Points From Baseline ([Week 0] of Prior Induction Study) in the Sub-population of Non-responders at Study Entry Over 112 Weeks | The CDAI score was determined by interactive voice response relationship (IVRS) based on the combination of participant and investigator entries and standardized weight determination. Haematocrit values received from the central laboratory on the day of the visit were to be utilized for calculation of the CDAI scores. The Baseline (Week 0) CDAI score was defined as the last evaluation prior to or on the date the first dose of investigational product was taken. Remissions are defined as subjects with CDAI score of < 150 points. Percentages are based on the number of subjects with observed data. No imputation for missing data was performed. | ITT population was planned to be analyzed for this study.However, this outcome measure was not analyzed due to termination of study and no data was collected for this outcome measure. | Posted | Baseline (Week 0) and up to 112 weeks |
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| Secondary | Change From Baseline (Week 0) in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form Health Survey (SF-36) Version 2, EuroQol 5 Dimensional (EQ-5D), Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and Disability Over 112 Weeks | IBDQ, SF-36, EQ-5D, WPAI-CD, and disability scores were all health outcome related scores that were based on assessment of participants based on different questionnaire. Each scoring scale had different range and participants were planned to be rated separately based on each scale. | ITT population was planned to be analyzed for this study. However, this outcome measure was not analyzed due to termination of study and no data was collected for this outcome measure. | Posted | Baseline (Week 0) and up to 112 weeks |
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On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the follow-up visit (up to 112 weeks).
On-treatment SAEs and non-serious AEs are reported for members of the safety Population, comprised of all participants who enrolled in the study except those who did not take at least one dose of investigational product.
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 | GSK1605786A | Eligible participants received oral GSK1605786A 500 mg BID for 216 weeks and were followed-up till 220 weeks. The participants who prematurely discontinued the study were followed by for last 4 weeks after receiving the last dose of the study drug. | 0 | 398 | 41 | 398 | 295 | 398 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Anal fistula | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gastrointestinal stenosis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Intestinal perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Large intestinal stenosis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Subileus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
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| Abdominal abscess | Infections and infestations | MedDRA | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Campylobacter gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA | Systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
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| Shigella infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Multiple sclerosis | Nervous system disorders | MedDRA | Systematic Assessment |
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| Myoclonus | Nervous system disorders | MedDRA | Systematic Assessment |
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| Incisional hernia | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Fistula | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA | Systematic Assessment |
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| Drug ineffective | General disorders | MedDRA | Systematic Assessment |
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| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Bartholinitis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Crohn's Disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
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| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C583420 | CCX282-B |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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