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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001123-20 | EudraCT Number | ||
| AALL1122 | Other Identifier | COG |
Not provided
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| Name | Class |
|---|---|
| Children's Oncology Group | NETWORK |
| EsPhALL | OTHER |
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The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Dasatinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dasatinib | Drug | Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year Event-free Survival (EFS) Rate | 3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment. Events for EFS are defined as ANY first one of the following:
| From first dose to 3 years following first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | Number of participants experiencing different types of all causality all grade adverse events | From first dose to 100 days following last dose (up to approximately 23 months) |
| Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates) |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37407142 | Derived | Hunger SP, Tran TH, Saha V, Devidas M, Valsecchi MG, Gastier-Foster JM, Cazzaniga G, Reshmi SC, Borowitz MJ, Moorman AV, Heerema NA, Carroll AJ, Martin-Regueira P, Loh ML, Raetz EA, Schultz KR, Slayton WB, Cario G, Schrappe M, Silverman LB, Biondi A. Dasatinib with intensive chemotherapy in de novo paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (CA180-372/COG AALL1122): a single-arm, multicentre, phase 2 trial. Lancet Haematol. 2023 Jul;10(7):e510-e520. doi: 10.1016/S2352-3026(23)00088-1. | |
| 33242441 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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106 participants were treated with dasatinib.
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dasatinib Cohort | Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
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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 28, 2013 | May 24, 2018 |
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Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last. |
| From first dose to 3 years or 5 years following first dose |
| Complete Remission Rate | Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. < 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants. | From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks) |
| Percentage of Participants Negative for Minimal Residual Disease (MRD) | MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1% | From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks) |
| Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse | A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR. | At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years) |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| University Of Arkansas For Medical Sciences | Little Rock | Arkansas | 72202 | United States |
| Antranik Agop Bedros | Loma Linda | California | 92350 | United States |
| Miller Children's and Women Hospital | Long Beach | California | 90806 | United States |
| Children'S Hospital Of L.A. | Los Angeles | California | 90027 | United States |
| Southern California Permanente Medical Group | Los Angeles | California | 90027 | United States |
| Valley Children's Hospital | Madera | California | 93636 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Lpch & Sumc | Palo Alto | California | 94304 | United States |
| Kaiser Medical Center | Roseville | California | 95661 | United States |
| Ucsf - Hematology/Oncology | San Francisco | California | 94143-0106 | United States |
| Children'S Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| A. I. Dupont Hospital For Children | Wilmington | Delaware | 19803 | United States |
| Children'S National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Lee Memorial Health System | Fort Myers | Florida | 33908 | United States |
| University Of Florida | Gainesville | Florida | 32610 | United States |
| Nemours Children'S Clinic | Jacksonville | Florida | 32207 | United States |
| Md Anderson Cancer Center Orlando | Orlando | Florida | 32806 | United States |
| Nemours Childrens Hospital | Orlando | Florida | 32827 | United States |
| All Children'S Hospital | St. Petersburg | Florida | 33629 | United States |
| St. Joseph's Children's Hospital | Tampa | Florida | 33607 | United States |
| St. Mary'S | West Palm Beach | Florida | 33407 | United States |
| Children's Healthcare Of Atlanta | Atlanta | Georgia | 30322 | United States |
| Kapiolani Medical Center For Women & Children | Honolulu | Hawaii | 96826 | United States |
| Mountain States Tumor Institute | Boise | Idaho | 83712 | United States |
| Ann & Robert H Lurie Children's Hospital Of Chicago | Chicago | Illinois | 60611 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Southern Illinois University School Of Medicine | Springfield | Illinois | 62794-9635 | United States |
| James Whitcomb Riley Hospital For Children | Indianapolis | Indiana | 46202-5225 | United States |
| Children'S Center For Cancer And Blood Diseases | Indianapolis | Indiana | 46260 | United States |
| University Of Kentucky | Lexington | Kentucky | 40536-0284 | United States |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Sinai Hospital Of Baltimore | Baltimore | Maryland | 21215 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21231 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Children'S Hospital Of Michigan | Detroit | Michigan | 48201 | United States |
| Helen Devos Children'S Hospital | Grand Rapids | Michigan | 49503 | United States |
| Michigan State University | Lansing | Michigan | 48912 | United States |
| Childrens Hospitals And Clinics Of Minnesota | Minneapolis | Minnesota | 55404 | United States |
| Univ Of Mississippi Med Ctr | Jackson | Mississippi | 39216 | United States |
| University Of Missouri Health Care | Columbia | Missouri | 65212 | United States |
| Children'S Mercy Hospital And Clinics | Kansas City | Missouri | 64108 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| Children'S Specialty Center Of Nevada | Las Vegas | Nevada | 89109 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Goryeb Children'S Hospital | Morristown | New Jersey | 07962 | United States |
| The Cancer Institute Of New Jersey | New Brunswick | New Jersey | 08901 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| St. Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | United States |
| University Of New Mexico | Albuquerque | New Mexico | 87131-0001 | United States |
| New York University | New York | New York | 10016 | United States |
| The Herbert Irving Pavilion | New York | New York | 10032 | United States |
| New York Presbyterian/Weill Cornell | New York | New York | 10065 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Levine Children's Hospital | Charlotte | North Carolina | 28203 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157-1081 | United States |
| Cincinnati Children'S Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Nationwide Children'S Hospital | Columbus | Ohio | 43205 | United States |
| The Children'S Medical Center Of Dayton | Dayton | Ohio | 45404-1815 | United States |
| The Toledo Children'S Hospital | Toledo | Ohio | 43606 | United States |
| Mercy Children's Hospital | Toledo | Ohio | 43608 | United States |
| University Of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Legacy Emanuel Hospital & Health Center | Portland | Oregon | 97227 | United States |
| Oregon Health & Sci Univ | Portland | Oregon | 97239 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-1320 | United States |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Children'S Hospital Of Philadelphia | Philadelphia | Pennsylvania | 19104-4318 | United States |
| Children's Hospital Of Pittsburgh Of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| East Tennessee Children'S Hosp | Knoxville | Tennessee | 37916 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232-6310 | United States |
| Dell Children'S Medical Center Of Central Texas | Austin | Texas | 78723 | United States |
| Driscoll Children'S Hospital | Corpus Christi | Texas | 78411 | United States |
| Ut Southwestern | Dallas | Texas | 75390-9063 | United States |
| Cook Children'S Hem/Onc Center | Fort Worth | Texas | 76104 | United States |
| Texas Children'S Cancer Center | Houston | Texas | 77030 | United States |
| Scott & White - McLane Children's Specialty Clinic | Temple | Texas | 76508 | United States |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113 | United States |
| Inova Pediatric Specialty Center Ii | Fairfax | Virginia | 22031 | United States |
| Children'S Hosp-Kings Daughter | Norfolk | Virginia | 23507 | United States |
| Seattle Children'S | Seattle | Washington | 98105 | United States |
| St Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| Kenneth Desantes, Md | Madison | Wisconsin | 53705-2275 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Local Institution | Sth Brisbane | Queensland | 4101 | Australia |
| Local Institution | Parkville | Victoria | 3052 | Australia |
| Local Institution | Nedlands | Western Australia | 6009 | Australia |
| Alberta Children'S Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| Stollery Children'S Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Local Institution | London | Ontario | N6A 5W9 | Canada |
| Children'S Hospital Of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Chu Ste-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| The Montreal Children's Hospital of the MUHC | Montreal | Quebec | H4A 3J1 | Canada |
| Local Institution | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| Local Institution | Bologna | 40138 | Italy |
| Local Institution | Cagliari | 09121 | Italy |
| Local Institution | Catania | 95123 | Italy |
| Local Institution | Florence | 50139 | Italy |
| Local Institution | Genova | 16147 | Italy |
| Local Institution | Monza | 20900 | Italy |
| Local Institution | Naples | 80123 | Italy |
| Local Institution | Palermo | 90134 | Italy |
| Local Institution | Roma | 00161 | Italy |
| Local Institution | Roma | 00165 | Italy |
| Local Institution | Torino | 10126 | Italy |
| Local Institution | Trieste | 34137 | Italy |
| Local Institution | San Juan | 00912 | Puerto Rico |
| Local Institution | Bristol | Avon | BS2 8BJ | United Kingdom |
| Local Institution | Cardiff | Glamorgan | CF14 4XW | United Kingdom |
| Local Institution | Aberdeen | Grampian | AB25 2ZG | United Kingdom |
| Local Institution | London | Greater London | WC1N3JH | United Kingdom |
| Local Institution | Manchester | Greater Manchester | M27 4HA | United Kingdom |
| Local Institution | Southampton | Hampshire | SO9 4XY | United Kingdom |
| Local Institution | Glasgow | Lanarkshire | G3 8SJ | United Kingdom |
| Local Institution | Edinburgh | Lothian | EH9 1LF | United Kingdom |
| Local Institution | Liverpool | Merseyside | L12 2AP | United Kingdom |
| Local Institution | Leeds | North Yorkshire | LS1 3EX | United Kingdom |
| Local Institution | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| Local Institution | Oxford | Oxfordshire | OX 39DU | United Kingdom |
| Local Institution | Sheffield | South Yorkshire | S10 2TH | United Kingdom |
| Local Institution | Sutton | Surrey | SM2 5PT | United Kingdom |
| Local Institution | Newcastle upon Tyne | Tyne and Wear | NE1 4LP | United Kingdom |
| Local Institution | Birmingham | West Midlands | B4 6NH | United Kingdom |
| Local Institution | Cambridge | CB2 2QQ | United Kingdom |
| Derived |
| Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available. |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dasatinib Cohort | Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All treated particpants | Mean | Standard Deviation | Years |
| ||||||||||||||||
| Sex: Female, Male | All treated particpants | Count of Participants | Participants |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | All treated participants | 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 | 3-year Event-free Survival (EFS) Rate | 3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment. Events for EFS are defined as ANY first one of the following:
| All treated partcipants | Posted | Number | 90% Confidence Interval | Percentage of Participants | From first dose to 3 years following first dose |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Adverse Events | Number of participants experiencing different types of all causality all grade adverse events | All treated participants | Posted | Count of Participants | Participants | From first dose to 100 days following last dose (up to approximately 23 months) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates) | Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last. | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose to 3 years or 5 years following first dose |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Complete Remission Rate | Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. < 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants. | All treated participants | Posted | Number | Percentage of Partcipants | From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Negative for Minimal Residual Disease (MRD) | MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1% | All treated participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse | A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR. | All treated participants with available measurements | Posted | Number | Percentage of participants | At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years) |
|
|
All cause mortality was assessed from first dose to study completion. SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 23 months)
Not provided
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 | Dasatinib Cohort | Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily. | 21 | 106 | 101 | 106 | 106 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| DISSEMINATED INTRAVASCULAR COAGULATION | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| FEBRILE BONE MARROW APLASIA | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| HAEMORRHAGIC ANAEMIA | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| LYMPHATIC DISORDER | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| PANCYTOPENIA | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | 20.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | 20.0 | Systematic Assessment |
| |
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | 20.0 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | 20.0 | Systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | 20.0 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | 20.0 | Systematic Assessment |
| |
| HYPOACUSIS | Ear and labyrinth disorders | 20.0 | Systematic Assessment |
| |
| ADRENAL INSUFFICIENCY | Endocrine disorders | 20.0 | Systematic Assessment |
| |
| PHOTOPHOBIA | Eye disorders | 20.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | 20.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| ANAL HAEMORRHAGE | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| ASCITES | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| DIARRHOEA HAEMORRHAGIC | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| ENTEROCOLITIS | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| GASTRIC HAEMORRHAGE | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| GASTRIC PERFORATION | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| GASTROINTESTINAL NECROSIS | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| ILEUS | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| INTESTINAL PERFORATION | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| LARGE INTESTINAL ULCER | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| NEUTROPENIC COLITIS | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| OESOPHAGITIS | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| PANCREATITIS | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| PROCTALGIA | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| PROCTITIS | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| CHILLS | General disorders | 20.0 | Systematic Assessment |
| |
| DEVICE RELATED THROMBOSIS | General disorders | 20.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | 20.0 | Systematic Assessment |
| |
| LOCALISED OEDEMA | General disorders | 20.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | 20.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | 20.0 | Systematic Assessment |
| |
| OEDEMA | General disorders | 20.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | 20.0 | Systematic Assessment |
| |
| PAIN | General disorders | 20.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | 20.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | 20.0 | Systematic Assessment |
| |
| HEPATITIS TOXIC | Hepatobiliary disorders | 20.0 | Systematic Assessment |
| |
| VENOOCCLUSIVE LIVER DISEASE | Hepatobiliary disorders | 20.0 | Systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | 20.0 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | 20.0 | Systematic Assessment |
| |
| ABDOMINAL INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| BACTERIAL SEPSIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CANDIDA INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CANDIDA PNEUMONIA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CATHETER SITE INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CELLULITIS OF MALE EXTERNAL GENITAL ORGAN | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CLOSTRIDIAL INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| COCCIDIOIDOMYCOSIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| EMPYEMA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| ENTEROCOLITIS BACTERIAL | Infections and infestations | 20.0 | Systematic Assessment |
| |
| ENTEROCOLITIS INFECTIOUS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| ESCHERICHIA BACTERAEMIA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| ESCHERICHIA SEPSIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| ESCHERICHIA URINARY TRACT INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| FUNGAL SEPSIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| HEPATIC INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | 20.0 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| KIDNEY INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| KLEBSIELLA BACTERAEMIA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| LOCALISED INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| MUCOSAL INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| NAIL BED INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| NAIL INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| NEUTROPENIC INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| OSTEOMYELITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| PASTEURELLA INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| PELVIC INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| PERINEAL CELLULITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| PERIORBITAL CELLULITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | 20.0 | Systematic Assessment |
| |
| PNEUMONIA VIRAL | Infections and infestations | 20.0 | Systematic Assessment |
| |
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| PSEUDOMONAL BACTERAEMIA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| RASH PUSTULAR | Infections and infestations | 20.0 | Systematic Assessment |
| |
| RESPIRATORY SYNCYTIAL VIRUS INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| SEPTIC EMBOLUS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| SEPTIC SHOCK | Infections and infestations | 20.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| SPLENIC INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| STREPTOCOCCAL SEPSIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| SYSTEMIC CANDIDA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| SYSTEMIC MYCOSIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| TOOTH ABSCESS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| TOOTH INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION ENTEROCOCCAL | Infections and infestations | 20.0 | Systematic Assessment |
| |
| VIRAL DIARRHOEA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| ALLERGIC TRANSFUSION REACTION | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| ANAPHYLACTIC TRANSFUSION REACTION | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| OVERDOSE | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| TOXICITY TO VARIOUS AGENTS | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| TRANSFUSION REACTION | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| TRAUMATIC FRACTURE | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| VASCULAR ACCESS COMPLICATION | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | 20.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | 20.0 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | 20.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | 20.0 | Systematic Assessment |
| |
| BLOOD CULTURE POSITIVE | Investigations | 20.0 | Systematic Assessment |
| |
| DRUG CLEARANCE DECREASED | Investigations | 20.0 | Systematic Assessment |
| |
| ENTEROVIRUS TEST POSITIVE | Investigations | 20.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | 20.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | 20.0 | Systematic Assessment |
| |
| TRANSAMINASES INCREASED | Investigations | 20.0 | Systematic Assessment |
| |
| TROPONIN I INCREASED | Investigations | 20.0 | Systematic Assessment |
| |
| URINE OUTPUT DECREASED | Investigations | 20.0 | Systematic Assessment |
| |
| VIRAL TEST | Investigations | 20.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | 20.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | 20.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT INCREASED | Investigations | 20.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPERNATRAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| PAIN IN JAW | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| RHABDOMYOLYSIS | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| ACUTE LYMPHOCYTIC LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Systematic Assessment |
| |
| ASTROCYTOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Systematic Assessment |
| |
| LEUKAEMIA RECURRENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 20.0 | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| DEPRESSED LEVEL OF CONSCIOUSNESS | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| DYSARTHRIA | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| ENCEPHALOPATHY | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| FACIAL PARESIS | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| LEUKOENCEPHALOPATHY | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | 20.0 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | 20.0 | Systematic Assessment |
| |
| PERSONALITY CHANGE | Psychiatric disorders | 20.0 | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | 20.0 | Systematic Assessment |
| |
| BLADDER SPASM | Renal and urinary disorders | 20.0 | Systematic Assessment |
| |
| CYSTITIS NONINFECTIVE | Renal and urinary disorders | 20.0 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | 20.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | 20.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | 20.0 | Systematic Assessment |
| |
| URINARY TRACT OBSTRUCTION | Renal and urinary disorders | 20.0 | Systematic Assessment |
| |
| OEDEMA GENITAL | Reproductive system and breast disorders | 20.0 | Systematic Assessment |
| |
| CHYLOTHORAX | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| PLEURITIC PAIN | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| PNEUMONITIS | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| RESPIRATORY DISTRESS | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| STRIDOR | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| RASH GENERALISED | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| RASH MACULAR | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | 20.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | 20.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | 20.0 | Systematic Assessment |
| |
| PERICARDIAL EFFUSION | Cardiac disorders | 20.0 | Systematic Assessment |
| |
| SINUS TACHYCARDIA | Cardiac disorders | 20.0 | Systematic Assessment |
| |
| TACHYCARDIA | Cardiac disorders | 20.0 | Systematic Assessment |
| |
| EAR PAIN | Ear and labyrinth disorders | 20.0 | Systematic Assessment |
| |
| EYE PAIN | Eye disorders | 20.0 | Systematic Assessment |
| |
| OCULAR HYPERAEMIA | Eye disorders | 20.0 | Systematic Assessment |
| |
| PERIORBITAL OEDEMA | Eye disorders | 20.0 | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | 20.0 | Systematic Assessment |
| |
| ABDOMINAL DISTENSION | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| ANAL INFLAMMATION | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| MOUTH ULCERATION | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| ORAL PAIN | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| PROCTALGIA | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | 20.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | 20.0 | Systematic Assessment |
| |
| CATHETER SITE ERYTHEMA | General disorders | 20.0 | Systematic Assessment |
| |
| CATHETER SITE PAIN | General disorders | 20.0 | Systematic Assessment |
| |
| CHILLS | General disorders | 20.0 | Systematic Assessment |
| |
| FACE OEDEMA | General disorders | 20.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | 20.0 | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | 20.0 | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | 20.0 | Systematic Assessment |
| |
| MALAISE | General disorders | 20.0 | Systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | 20.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | 20.0 | Systematic Assessment |
| |
| OEDEMA | General disorders | 20.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | 20.0 | Systematic Assessment |
| |
| PAIN | General disorders | 20.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | 20.0 | Systematic Assessment |
| |
| DRUG HYPERSENSITIVITY | Immune system disorders | 20.0 | Systematic Assessment |
| |
| CANDIDA INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| CONJUNCTIVITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| DEVICE RELATED INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| EAR INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| ENTEROCOLITIS INFECTIOUS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| LUNG INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| ORAL CANDIDIASIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| OTITIS MEDIA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | 20.0 | Systematic Assessment |
| |
| RHINITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| RHINOVIRUS INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | 20.0 | Systematic Assessment |
| |
| SKIN INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | 20.0 | Systematic Assessment |
| |
| ALLERGIC TRANSFUSION REACTION | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| ARTHROPOD BITE | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| SKIN ABRASION | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| SUNBURN | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| TRANSFUSION REACTION | Injury, poisoning and procedural complications | 20.0 | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | 20.0 | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | 20.0 | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | 20.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | 20.0 | Systematic Assessment |
| |
| CARDIAC MURMUR | Investigations | 20.0 | Systematic Assessment |
| |
| ELECTROCARDIOGRAM QT PROLONGED | Investigations | 20.0 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | 20.0 | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | 20.0 | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | 20.0 | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | 20.0 | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | 20.0 | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | 20.0 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | 20.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPOCALCAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPOMAGNESAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | 20.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| NECK PAIN | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| PAIN IN JAW | Musculoskeletal and connective tissue disorders | 20.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | 20.0 | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | 20.0 | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | 20.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | 20.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | 20.0 | Systematic Assessment |
| |
| IRRITABILITY | Psychiatric disorders | 20.0 | Systematic Assessment |
| |
| DYSURIA | Renal and urinary disorders | 20.0 | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | 20.0 | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | 20.0 | Systematic Assessment |
| |
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| RESPIRATORY TRACT CONGESTION | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| SNEEZING | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| TACHYPNOEA | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| WHEEZING | Respiratory, thoracic and mediastinal disorders | 20.0 | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| ECCHYMOSIS | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| PAIN OF SKIN | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| PETECHIAE | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| RASH PAPULAR | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| SWELLING FACE | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | 20.0 | Systematic Assessment |
| |
| FLUSHING | Vascular disorders | 20.0 | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | 20.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | 20.0 | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | 20.0 | Systematic Assessment |
| |
| PALLOR | Vascular disorders | 20.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email: | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 28, 2013 | May 24, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided
| Follow-up no longer required per protocol |
|
| Other and not reported reasons |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Difference in 3-year binomial EFS rate for all treated participants (dasatinib plus chemotherapy) vs. continuous imatinib plus chemotherapy in the Amended EsPhALL Trial Historical Control |
| Chi-squared |
| 0.271 |
Superiority test versus EsPhALL |
| Estimate of difference |
| 6.91 |
| 2-Sided |
| 90 |
| -3.3 |
| 17.2 |
Treatment difference (CA180372 - EsPhALL) Test if lower confidence limit is above -5% |
| Non-Inferiority |
non-inferiority margin = 5%. One-sided type I error rate of 0.05 |
| Chi-squared | 0.157 | Estimate of difference | -10.75 | 2-Sided | 90 | -22.7 | 1.2 | Treatment difference (CA180372 - COG AALL0031) | Superiority | Difference in 3-year binomial EFS rate in all treated participants (dasatinib plus chemotherapy) vs. chemotherapy alone in COG AALL0031 historical control |
|
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