Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000722-30 | EudraCT Number | ||
| ANDANTE II | Other Identifier | Alias Study Number |
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This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04236921 | Biological | Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs. | Baseline up to Week 48 |
| Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) | Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (>=) 4.32. Any positive ADA sample was further tested for NAbs. | At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Simon Medical Imaging | Scottsdale | Arizona | 85258 | United States | ||
| Digestive Health Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29247068 | Derived | Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-04236921 | All participants entering this study were given a 50 mg subcutaneous (SC) dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PF-04236921 | Biological | Dose escalation to 100 mg SC every 8 weeks will be allowed for subjects who have either not responded at Week 8 or have relapsed during the study. |
|
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Adobe Clinical Research, LLC | Tucson | Arizona | 85712 | United States |
| Adobe Surgery Center | Tucson | Arizona | 85712 | United States |
| Rocky Mountain Gastroenterology Associates | Lakewood | Colorado | 80215 | United States |
| Rocky Mountain Gastroenterology | Littleton | Colorado | 80120 | United States |
| Rocky Mountain Clinical Research, LLC. | Wheat Ridge | Colorado | 80033 | United States |
| Rocky Mountain Clinical Research, LLC | Wheat Ridge | Colorado | 80033 | United States |
| Medical Research Center of Connecticut, LLC | Hamden | Connecticut | 06518 | United States |
| Gastroenterology Consultants of Clearwater | Clearwater | Florida | 33756 | United States |
| Clinical Research of West Florida, Inc. | Clearwater | Florida | 33765 | United States |
| Gastroenterology Associates | Crystal River | Florida | 34429 | United States |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | United States |
| Suncoast Endoscopy Center | Inverness | Florida | 34453 | United States |
| International Clinical Research - US, LLC | Sanford | Florida | 32771 | United States |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | 30033 | United States |
| The Atlanta Center For Gastroenterology | Decatur | Georgia | 30033 | United States |
| Gastointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | United States |
| Illinois Gastroenterology Group, LLC | Arlington Heights | Illinois | 60005 | United States |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | United States |
| U of L Health Care Outpatient Center | Louisville | Kentucky | 40202 | United States |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| Digestive Disorders Associates | Annapolis | Maryland | 21401 | United States |
| Drgestive Disorders Associates | Annapolis | Maryland | 21401 | United States |
| East Valley Endoscopy | Grand Rapids | Michigan | 49546 | United States |
| Gastroenterology Associates of Western Michigan | Wyoming | Michigan | 49519 | United States |
| Metro Health Hospital Endoscopy Unit | Wyoming | Michigan | 49519 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| Huron Gastroenterology Associates | Ypsilanti | Michigan | 48197 | United States |
| Weill Cornell Medical College of Cornell University | New York | New York | 10021 | United States |
| Present, Chapman, Steinlauf and Marion | New York | New York | 10028 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| New York Presbyterian Hospital - Weill Cornell Medical College Investigational Pharmacy | New York | New York | 10065 | United States |
| Weill Cornell Imaging at New York Presbyterian Hospital | New York | New York | 10065 | United States |
| Weill Cornell Medical College of Cornell University-Greenberg | New York | New York | 10065 | United States |
| Arthur Asher Kombluth, MD PC | New York | New York | 10128 | United States |
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73102 | United States |
| Pharmacy: Wheeler and Stuckey, Inc. | Oklahoma City | Oklahoma | 73103 | United States |
| Colonoscopy and X-rays: OU Physicians Building | Oklahoma City | Oklahoma | 73104 | United States |
| Hillcrest Medical Center | Tulsa | Oklahoma | 74104 | United States |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104 | United States |
| Pittsburgh Gastroenterology Associates | Pittsburgh | Pennsylvania | 15241 | United States |
| Research Protocol Management Specialists | Pittsburgh | Pennsylvania | 15243 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center: IBD Clinic | Nashville | Tennessee | 37212-1375 | United States |
| Vanderbilt University Medical Center-GI Research | Nashville | Tennessee | 37212-1610 | United States |
| IBD Center-Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Vanderbilt University Medical Center-IDS | Nashville | Tennessee | 37212 | United States |
| Professional Quality Research, Inc. | Austin | Texas | 78705 | United States |
| Austin Gastroenterology, PA | Austin | Texas | 78745 | United States |
| Diagnostic Clinic Of Houston Pa | Houston | Texas | 77004 | United States |
| Diagnostic Clinic of Houston, PA | Houston | Texas | 77004 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| The University of TX Health Sci. Ctr at Houston | Houston | Texas | 77030 | United States |
| Texas Digestive Disease Consultants | Southlake | Texas | 76092 | United States |
| Clinical Pathologiy Laboratories, Inc, DBA DRL Labs | Tyler | Texas | 75701 | United States |
| Digestive Health Specialists of Tyler | Tyler | Texas | 75701 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| VC Medical Center Investigative Drug Service (IDS) [Ship Drug To] | Richmond | Virginia | 23298 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| Royal Brisbane and Women's Hospital | Brisbane | Queensland | 4029 | Australia |
| Mater Health Services | South Brisbane | Queensland | 4101 | Australia |
| Eastern Health, Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| St. Vincent's Hospital | Fitzroy | Victoria | 3065 | Australia |
| CHU Saint-Pierre | Brussels | 1000 | Belgium |
| Chu St Pierre | Brussels | 1000 | Belgium |
| University Hospital Leuven, Campus Gasthuisberg | Leuven | 3000 | Belgium |
| H.-Hartziekenhuis Roeselare-Menen vzw | Roeselare | 8800 | Belgium |
| Hospital Nossa Senhora das Gracas | Curitiba | Paraná | 80810-040 | Brazil |
| Setor de Cardiologia do Hospital Nossa Senhora das Gracas | Curitiba | Paraná | 80810-040 | Brazil |
| Setor de Endoscopia Digestiva do Hospital Nossa Senhora das Gracas | Curitiba | Paraná | 80810-040 | Brazil |
| Hospital Universitário Fraga Filho da UFRJ | Rio de Janeiro | Rio de Janeiro | 21941-913 | Brazil |
| Laboratório de Análises ClÃnicas do HUCFF/UFRJ | Rio de Janeiro | Rio de Janeiro | 21941-913 | Brazil |
| Hospital Israelita Albert Einstein | São Paulo | São Paulo | 05651-901 | Brazil |
| Heritage Medical Research Clinic - University of Calgary | Calgary | Alberta | T2N4Z6 | Canada |
| London Health Science Centre - University Hospital | London | Ontario | N6A 5A5 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Montreal General Hospital - McGill University Health Centre | Montreal | Quebec | H3G 1A4 | Canada |
| Hepato-Gastroenterologie HK, s.r.o. Poliklinika III | Hradec Králové | 500 12 | Czechia |
| Fakultni nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Fakultni Nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Institut klinicke a experimentalni mediciny | Prague | 140 21 | Czechia |
| Krajska zdravotni, a.s. | Ústà nad Labem | 40113 | Czechia |
| Aarhus Universitetshospital, Aarhus Sygehus | Aarhus C | 8000 | Denmark |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| "Gastroenheden Herlev Hospital | Herlev | 2730 | Denmark |
| "Kirurgisk Afdeling 0143 Hilleroed Hospital | Hilleroed | 3400 | Denmark |
| Hvidovre Hospital | Hvidovre | 2650 | Denmark |
| Bispebjerg Hospital | Koebenhavn NV | 2400 | Denmark |
| Medicinsk Afdeling, Gastroenterologisk Sektion | Koege | 4600 | Denmark |
| Hopital Saint-Antoine - Service De Gastroenterologie | Paris | Cedex 12 | 75571 | France |
| Hopital Huriez CHRU de Lille | Lille | 59037 | France |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| Praxis Dr. Howaldt | Hamburg | 20148 | Germany |
| Universitaetsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| Gastroenterologische Gemeinschaftspraxis Minden | Minden | 32423 | Germany |
| Pannonia Maganorvosi Centrum Kft. | Budapest | 1136 | Hungary |
| Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum | Debrecen | 4032 | Hungary |
| Szegedi Tudomanyegyetem altalanos Orvostudomanyi Kar / I. sz. Belgyogyaszati Klinika | Szeged | 6720 | Hungary |
| Clinfan Kft. | Szekszárd | 7100 | Hungary |
| National Virus Reference Laboratory | Dublin | D04 FX62 | Ireland |
| Pathology, Haematology and Biochemistry Laboratories, St. Vincent's Healthcare Group | Dublin | D04 T6F4 | Ireland |
| Mater Misericordiae Hospital, Department of Clinical Chemistry and Clinical Haematology | Dublin | D07 K201 | Ireland |
| St. Vincents University Hospital | Dublin | DUBLIN 4 | Ireland |
| University Hospital Galway | Galway | Ireland |
| Digestive Disease Institute | Beith Vagan | Jerusalem | 91031 | Israel |
| Institute of Gastroenterology | Haifa | 3339419 | Israel |
| Hadassah university Hospital (HUH) - Ein Karem, Hadassah Medical Organization (HMO) | Jerusalem | 91120 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| Rabin Medical Center, Beilinson Hospital | Petah Tikva | 49100 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Istituto Clinico Humanitas IRCCS | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedaliera - Universita di Padova | Padova | 35128 | Italy |
| Universita Campus Biomedico UOC di Gastroenterologia | Roma | 00128 | Italy |
| AOS San Camillo Forlanini | Rome | 00152 | Italy |
| Shakespeare Specialist Group | Milford | Auckland | 0620 | New Zealand |
| Waikato Hospital | Hamilton | 3204 | New Zealand |
| Universitaetsspital Zuerich | Zurich | 8091 | Switzerland |
| Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Glasgow Royal Infirmary | Glasgow | G4 0SS | United Kingdom |
| Barts Health NHS Trust-Royal London Hospital | London | E1 1BB | United Kingdom |
| Clinical Research Centre | London | E1 2AT | United Kingdom |
| St Bartholomew's Hospital (Barts Health NHS Trust) | London | EC1A 7BE | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Included all participants who received at least 1 dose of study treatment during the study B0151005
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-04236921 | All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With On-Treatment Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs. | The safety analysis set was defined as all participants who received at least one dose of PF-04236921during the study. | Posted | Number | participants | Baseline up to Week 48 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) | Samples were analyzed using the semi-quantitative electrochemiluminescent (ECL) immunoassay method, a validated analytical method in compliance with sponsor's standard operating procedures. ADA positive is defined as ADA titer greater than or equal to (>=) 4.32. Any positive ADA sample was further tested for NAbs. | The safety analysis set was defined as all participants who received at least one dose of PF-04236921during the study. | Posted | Number | percentage of participants | At Baseline and Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 and 76. |
|
|
Not provided
The same event might have appeared as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant might have experienced both a serious and non-serious event during the study.
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 | PF-04236921 | All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8. | 79 | 191 | 150 | 191 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anorectal disorder | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fistula of small intestine | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cholangitis sclerosing | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bartholin's abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment | Percentages of gender specific events are calculated using the corresponding gender count as denominator. |
|
| Cellulitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Groin abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Mesenteric abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Retroperitoneal abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anastomotic fistula | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Intestinal anastomosis complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oncocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Non-systematic Assessment | Percentages of gender specific events are calculated using the corresponding gender count as denominator. |
|
| Calculus ureteric | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000620303 | PF-04236921 |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
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