Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005101-31 | EudraCT Number | ||
| B1871053 | Other Identifier | Alias Study Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.
The study will be open for enrollment until the planned number of approximately 500 Philadelphia Chromosome Positive (Ph+) patients have been randomized (approximately 250 Ph+ patients in each treatment arm; a total of approximately 530 Ph+ and Ph- patients). All patients will be treated and/or followed for approximately 5 years (240 weeks) after randomization until the study has closed. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 5 years (240 weeks) after randomization.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bosutinib | Experimental | Bosutinib, 400 mg, oral administration once a day |
|
| Imatinib | Active Comparator | Imatinib, 400 mg, oral administration once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosutinib | Drug | Bosutinib (Bosulif®) is an orally bioavailable, potent, multi-targeted, dual Src-Abl tyrosine kinase inhibitor (TKI) that has been approved for the treatment of adult patients with Philadelphia positive (Ph+) chronic phase (CP), accelerated phase (AP) and blast phase (BP) chronic myelogenous leukemia (CML) previously treated with other TKI inhibitor therapy.[1] This study will investigate the use of bosutinib as first-line treatment for patients with Ph+ CP CML. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Major Molecular Response (MMR) at Month 12 | MMR was defined as a ratio of breakpoint cluster region to abelson (BCR-ABL/ABL) less than or equal to (<=) 0.1 percent (%) on the international scale (IS) (greater than or equal to [>=] 3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts [>=3000 ABL required]) by quantitative reverse transcriptase polymerase chain reaction (RT-qPCR). The percentage of participants with MMR at Month 12 are reported. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Major Molecular Response (MMR) Up to Month 18 | MMR was defined as a ratio of BCR-ABL/ABL <=0.1% on the international scale (>=3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts [>=3000 ABL required]) by quantitative RT-qPCR. The percentage of participants with MMR for up to Month 18 are reported. | Up to Month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Trough Plasma Concentration by Complete Cytogenetic Response (CCyR) of Bosutinib | CCyR was based on the prevalence of Ph+ metaphases among cells in metaphase on a BM aspirate. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. Trough plasma concentration of participants who had CCyR are presented in this outcome measure. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Cancer Medical Center, Inc. | Anaheim | California | 92801 | United States | ||
| Emory University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37553873 | Derived | Garrett M, Knight B, Cortes JE, Deininger MW. Population modeling of bosutinib exposure-response in patients with newly diagnosed chronic phase chronic myeloid leukemia. Cancer Med. 2023 Sep;12(17):17981-17992. doi: 10.1002/cam4.6439. Epub 2023 Aug 8. | |
| 35643868 | Derived | Brummendorf TH, Cortes JE, Milojkovic D, Gambacorti-Passerini C, Clark RE, le Coutre P, Garcia-Gutierrez V, Chuah C, Kota V, Lipton JH, Rousselot P, Mauro MJ, Hochhaus A, Hurtado Monroy R, Leip E, Purcell S, Yver A, Viqueira A, Deininger MW; BFORE study investigators. Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial. Leukemia. 2022 Jul;36(7):1825-1833. doi: 10.1038/s41375-022-01589-y. Epub 2022 May 28. |
Not provided
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bosutinib | Participants with Philadelphia chromosome-positive chronic myeloid leukemia (CML) received bosutinib tablets at a dose of 400 milligram (mg), orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
NOTE: Value was Open Label in old format; This study has an open-label design. Although most efficacy studies have a double blind design, this is not feasible in this trial, due to the complexity of the dose reduction and dose escalation schemes with tablets of various sizes, dosage strengths, as well as the number of tablets that would be required daily. However, the opportunity for bias is mitigated by the use of objective outcome measures (MMR, CCyR, CHR). The Investigators will be instructed to ensure that laboratory/pathology personnel are blinded to treatment information. For these reasons, an open-label, randomized study is appropriate.
Not provided
|
| Imatinib | Drug | Imatinib mesylate (referred to in this protocol as imatinib) is an inhibitor of the BCR-ABL kinase and been the standard first-line therapy for patients with chronic-phase CML. Imatinib was granted approval by the European Commission in November 2001 and by the FDA in December 2002 for the treatment of newly diagnosed patients with CP Ph+ CML based on results from the IRIS trial. Imatinib is considered the standard of care for both first-line and later line settings, and consequently is an appropriate active comparator. |
|
| Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 48 | The Kaplan-Meier curve was generated based on the first date of MMR until the date of the confirmed loss of MMR or censoring, objectively documented, for responders only. Confirmed loss of MMR was BCR-ABL/ABL IS ratio >0.1% in association with a >=5-fold increase in BCR-ABL/ABL IS ratio from the lowest value achieved up to that time-point confirmed by a second assessment at least 28 days later. Treatment discontinuation due to suboptimal response/treatment failure, progressive disease (PD) or death due to PD within 28 days of last dose were considered confirmed loss of MMR. PD was defined as disease progression to accelerated phase (AP) or blast phase (BP) CML. | Month 48 |
| Percentage of Participants With Complete Cytogenetic Response (CCyR) Up to Month 12 | Complete Cytogenetic Response (CCyR) was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. The percentage of participants with CCyR for up to Month 12 are reported. | Up to Month 12 |
| Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 48 | The Kaplan-Meier curve was generated based on the first date of CCyR until the date of the confirmed loss of CCyR or censoring, objectively documented, for responders only. Confirmed loss of CCyR was the presence of at least one Ph+ metaphase confirmed by a second assessment at least 28 days later. Treatment discontinuation due to suboptimal response/treatment failure, PD or death due to PD within 28 days of last dose were considered confirmed loss of CCyR. PD was defined as disease progression to AP or BP CML. | Month 48 |
| Cumulative Incidence of Event Free Survival (EFS) Events | EFS was defined as time from randomization to death due to any cause, transformation to AP or BP at any time, confirmed loss of complete hematologic response (CHR), confirmed loss of CCyR or censoring. Loss of CHR was defined as a hematologic assessment of non-CHR (chronic phase, AP, or BP) confirmed by 2 assessments at least 4 weeks apart. Loss of CHR was defined as appearance of any of the following: WBC count that rises to >20.0*10^9/L, platelet count rises to >=600*10^9/L, appearance of palpable spleen or other extramedullary involvement proven by biopsy, appearance of 5% myelocytes in peripheral blood, appearance of blasts or promyelocytes in peripheral blood. Loss of CCyR was defined as at least 1 Ph+ metaphase from analysis of <100 metaphases confirmed by follow up cytogenetic analysis after 1 month. Cumulative incidence of EFS was defined as percentage of participants with EFS event at Month 60 and was adjusted for competing risk of treatment discontinuation without event. | Up to Month 60 |
| Overall Survival (OS) Rate | OS was defined as the time (in months) from randomization to the occurrence of death due to any cause or censoring. Kaplan-meier analysis was used for determination of OS. Percentage of participants who were alive were estimated in this outcome measure. | Up to Month 60 |
| Pre-dose on Days 28, 56 and 84 |
| Summary of Trough Plasma Concentration by Major Molecular Response (MMR) of Bosutinib | MMR was defined as a ratio of BCR-ABL/ABL <=0.1% on the international scale (>=3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts) by quantitative RT-qPCR. Trough plasma concentration of participants who had MMR are presented in this outcome measure. | Pre-dose on Days 28, 56 and 84 |
| Summary of Trough Plasma Concentration by Presence of Grade 1 or Higher Adverse Events (AEs) of Bosutinib | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening or disabling; urgent intervention indicated; Grade 5= death. Trough plasma concentration of participants who had grade 1 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separately for each preferred term of AE. | Pre-dose on Days 28, 56 and 84 |
| Summary of Trough Plasma Concentration by Presence of Grade 3 or Higher Adverse Events (AEs) of Bosutinib | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on NCI CTCAE version 4.0. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening or disabling; urgent intervention indicated; Grade 5= death. Trough plasma concentration of participants who had grade 3 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separately for each preferred term of AE. | Pre-dose on Days 28, 56 and 84 |
| Number of Participants With Vital Signs Abnormalities | Criteria for vital signs abnormalities: systolic blood pressure <80 millimeter of mercury (mmHg), >210 mmHg; diastolic blood pressure <40 mmHg, >130 mmHg; heart rate <40 beats per minute (bpm), >150 bpm; temperature <32 degree celsius, >40 degree celsius; weight >=10% increase from baseline, >=10% decrease from baseline. The number of participants with any vital sign abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article until the last date of test article +28 days. | Baseline up to end of treatment (up to Month 60) |
| Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Version 4.03 | Laboratory parameters included hematological (haemoglobin, lymphocytes [absolute], neutrophils [absolute], platelets and leukocytes) and biochemistry (albumin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, amylase, bilirubin, creatinine kinase, calcium, creatinine, glucose, potassium, lipase, magnesium, phosphate, sodium, urate) parameters. Abnormalities in laboratory tests were graded by NCI CTCAE version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. The number of participants with laboratory test abnormalities were reported. | Baseline up to end of treatment (up to Month 60) |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Criteria for ECG abnormalities included heart rate: increase of >15 bpm from baseline value and >=120 bpm, decrease of >15 bpm from baseline value and <=45 bpm; PR interval: change of >=20 msec from baseline value and >=220 milliseconds (msec); QRS interval >=120 msec; QTcB interval >500 msec, increase of >60 msec from baseline; >450 msec (Men) or >470 msec (Women). QT interval using Fridericia's correction (QTcF) >500 msec, increase of >60 msec from baseline, >450 msec (Men) or >470 msec (Women). The number of participants with ECG abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article up until the last date of test article +28 days. | Baseline up to end of treatment (up to Month 60) |
| Number of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Baseline up to end of treatment (up to Month 60) |
| Number of Participants With Treatment-Emergent Adverse Events by National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.0) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE version 4.0. Grade 1 =mild; Grade 2 =moderate; Grade 3 =severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4 =life-threatening or disabling, urgent intervention indicated; Grade 5 =death. Treatment-emergent events were events between first dose of study drug and up to 60 months that were absent before treatment that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 adverse event, only the maximum CTCAE was reported. | Baseline up to end of treatment (up to Month 60) |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | United States |
| Kaiser Permanente Hawaii | Honolulu | Hawaii | 96819 | United States |
| Saint Alphonsus Regional Medical Center, Cancer Care Center | Boise | Idaho | 83706 | United States |
| Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | United States |
| Saint Alphonsus Caldwell Cancer Care Center | Caldwell | Idaho | 83605 | United States |
| Saint Alphonsus Medical Center Nampa | Nampa | Idaho | 83686 | United States |
| University of Illinois Cancer Center | Chicago | Illinois | 60612 | United States |
| John H. Stroger, Jr. Hospital of Cook County | Chicago | Illinois | 60621 | United States |
| Indiana Blood and Marrow Transplantation | Indianapolis | Indiana | 46237 | United States |
| PHARMACY Department Franciscan St. Francis Health ATTN:Jill Leslie, Pharm D | Indianapolis | Indiana | 46237 | United States |
| Cancer Center of Acadiana at Lafayette General Medical Center | Lafayette | Louisiana | 70503 | United States |
| Lafayette General Medical Center | Lafayette | Louisiana | 70503 | United States |
| LSU Health Sciences Center-Shreveport | Shreveport | Louisiana | 71103 | United States |
| University Health Shreveport | Shreveport | Louisiana | 71103 | United States |
| Rcca Md Llc | Bethesda | Maryland | 20817 | United States |
| University of Massachusetts Memorial Medical Center, ONC/Research Pharmacy | Worcester | Massachusetts | 01655 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| St. Joseph Mercy Hospital - Inpatient Pharmacy | Ann Arbor | Michigan | 48106 | United States |
| St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | United States |
| St. Joseph Mercy-Brighton | Brighton | Michigan | 48114 | United States |
| St. Joseph Mercy-Canton | Canton | Michigan | 48188 | United States |
| Chelsea Community Hospital | Chelsea | Michigan | 48118-1370 | United States |
| St. John Hospital&Medical Center | Detroit | Michigan | 48236 | United States |
| St. John Hospital&Medical Center-Van Elslander Cancer Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Van Elslander Cancer Center, Pharmacy | Grosse Pointe Woods | Michigan | 48236 | United States |
| Minnesota Oncology Hematology, PA | Edina | Minnesota | 55435 | United States |
| Park Nicollet Frauenshuh Cancer center | Saint Louis Park | Minnesota | 55426 | United States |
| Lakeview Hospital | Stillwater | Minnesota | 55082 | United States |
| North Mississippi Medical Center Hematology and Oncology Clinic | Tupelo | Mississippi | 38801 | United States |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| NYU Winthrop Hospital - Oncology / Hematology department | Mineola | New York | 11501 | United States |
| NYU Winthrop Hospital - Pharmacy Department | Mineola | New York | 11501 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| University of Rochester Investigational Drug Pharmacy | Rochester | New York | 14642 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| FirstHealth Moore Regional Hospital | Pinehurst | North Carolina | 28374 | United States |
| FirstHealth Outpatient Cancer Center | Pinehurst | North Carolina | 28374 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| UC Health Physicians Office South, | West Chester | Ohio | 45069 | United States |
| MUSC University Hospital | Charleston | South Carolina | 29425 | United States |
| MUSC University of South Carolina, Investigational Drug Services | Charleston | South Carolina | 29425 | United States |
| MUSC-Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| GHS Cancer Institute | Easley | South Carolina | 29640 | United States |
| GHS Cancer Institute | Greenville | South Carolina | 29605 | United States |
| GHS Cancer Institute | Greenville | South Carolina | 29615 | United States |
| GHS Cancer Institute | Greer | South Carolina | 29650 | United States |
| GHS Cancer Institute | Seneca | South Carolina | 29672 | United States |
| GHS Cancer Institute | Spartanburg | South Carolina | 29307 | United States |
| The University of Texas, MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Utah Cancer Specialists | Murray | Utah | 84157 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| Huntsman Cancer Hospital | Salt Lake City | Utah | 84112 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| HSHS St. Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Mary's Hospital Medical Center | Green Bay | Wisconsin | 54303 | United States |
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| St George Hospital - Hematology Department | Kogarah | New South Wales | 2217 | Australia |
| Eastern Clinical Research Unit, Level 2 | Box Hill | Victoria | 3128 | Australia |
| UZ Ghent (University Hospital Ghent) | Ghent | 9000 | Belgium |
| Department of Haematology at UZ Leuven (7 th Floor) | Leuven | 3000 | Belgium |
| Hematology Department of CHU de Liège | Liège | 4000 | Belgium |
| Hematology Department CHR Verviers | Verviers | 4800 | Belgium |
| Horizon Health Network - The Moncton Hospital | Moncton | New Brunswick | E1C 6Z8 | Canada |
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| Lakeridge Health | Oshawa | Ontario | L1G 2B9 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| CHU de Québec - Université Laval | Québec | G1J 1Z4 | Canada |
| Fakultní Nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultní Nemocnice Hradec Králové | Hradec Králové | 500 05 | Czechia |
| Fakultní nemocnice Olomouc | Olomouc | 775 20 | Czechia |
| Všeobecná fakultní Nemocnice v Praze | Prague | 128 08 | Czechia |
| Aalborg University Hospital | Aalborg | 9000 | Denmark |
| Aarhus University Hospital | Aarhus | 8000 | Denmark |
| Roskilde Hospital | Roskilde | 4000 | Denmark |
| Helsinki University Central Hospital | Helsinki | 00029 HUS | Finland |
| Oncologie Centre de Radiotherapie | Strasbourg | NC | 67000 | France |
| Institut Bergonié | Bordeaux | 33076 | France |
| private Practice of Pr Philippe Rousselot | Le Chesnay | 78157 | France |
| private Practice of Dr. Viviane Dubruille | Nantes | 44093 | France |
| Hôpital L'Archet 1-CHU Nice | Nice | 06202 | France |
| Institut de Cancérologie du Gard - Hématologie Clinique | Nîmes | 30029 | France |
| Pr Mauricette Michallet Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| INSERM CIC 1402 - CHU Poitiers | Poitiers | 86021 | France |
| Institut Universitaire du Cancer de Toulouse - Oncopole | Toulouse | 31059 | France |
| Universitätsklinikum Bonn | Bonn | Rhineland-Palatinate | 53105 | Germany |
| Uniklinikum Aachen | Aachen | 52074 | Germany |
| Charité, CVK, Med. Klinik m.S Hämatologie und Onkologie | Berlin | 13353 | Germany |
| Universitätsklinikum Freiburg, Klinik für Innere Medizin I | Freiburg im Breisgau | 79106 | Germany |
| Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum | Hamburg | 20251 | Germany |
| Universitätsklinikum Jena, Klinik für Innere Medizin II | Jena Lobeda-Ost | 07747 | Germany |
| Schwerpunktpraxis für Hämatologie und Onkologie | Magdeburg | 39104 | Germany |
| Semmelweis Egyetem I. Belgyógyászat | Budapest | 1083 | Hungary |
| Debreceni Egyetem Klinikai Központ, Belgyógyászati Inézet Hematológiai Tanszék | Debrecen | 4032 | Hungary |
| Petz Aladár Megyei OktatóKórház, II. Belgyógyászati Osztály és Haematológiai Részleg | Győr | 9023 | Hungary |
| Somogy Megyei Kaposi Mór Oktató Kórház | Kaposvár | 7400 | Hungary |
| Szegedi Tudományegyetem, AOK, Szent-Györgyi Albert Klinikai Központ, II. sz. | Szeged | 6725 | Hungary |
| Jász-Nagykun-Szolnok Megyei Hetényi, Géza Kórház-Rendelőintézet | Szolnok | 5000 | Hungary |
| Hematology Department, Rambam Medical Centre | Haifa | 31096 | Israel |
| Hematology Div. Davidoff Cancer Center, Rabin Medical Center | Petah Tikva | 49100 | Israel |
| Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele" - P.O. G. Rodolico | Catania | CT | 95123 | Italy |
| USC Ematologia, A. O. Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| Policlinico S. Orsola - Malpighi, | Bologna | 40138 | Italy |
| A.O. Brozu - P.O. Armando Businco | Cagliari | 09121 | Italy |
| Azienda Ospedaliero Universitaria Careggi | Florence | 50134 | Italy |
| IRCCS - AOU San Martino_IST, Ematologia 1 | Genova | 16132 | Italy |
| Istituto Scientifico San Raffaele | Milan | 20132 | Italy |
| Unità di Ricerca Clinica, U.O. Ematologia Adulti | Monza | 20900 | Italy |
| A.O.U. Policlinico Università degli Studi di Napoli "Federico II" | Naples | 80131 | Italy |
| Dipartimento di ematologia | Reggio Calabria | 89124 | Italy |
| ASL Roma 2 - Ospedale Sant'Eugenio | Roma | 00144 | Italy |
| Hospital Angeles del Pedregal (S.A. de C.V.) | Mexico City | Mexico City | 10700 | Mexico |
| Monterrey International Research Center | Monterrey | Nuevo León | 64000 | Mexico |
| Klinische Farrnacologie en Apotheek | Amsterdam | North Holland | 1081 BT | Netherlands |
| VU University Medical Center | Amsterdam | North Holland | 1081 HV | Netherlands |
| Haukeland University Hospital Department of Hematology | Bergen | 5021 | Norway |
| St. Olavs Hospital | Trondheim | 7006 | Norway |
| Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne | Gdansk | Pomeranian Voivodeship | 80-214 | Poland |
| SPZOZ ZSM w Chorzowie Oddzial Hematologiczny | Chorzów | 41-500 | Poland |
| Samodzielny Publiczny Szpital Kliniczny im. A Mielęckiego, ŚUM w Katowicach | Katowice | 40032 | Poland |
| Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Hematologii | Krakow | 31501 | Poland |
| Wojewódzki Szpital Specjalistyczny im M. Kopernika, Klinika Hematologii Uniwersytetu Medycznego | Lodz | 93510 | Poland |
| SPSK, Klinika Hematoonkologii i Transplantacji Szpiku w Lublinie | Lublin | 20081 | Poland |
| Universytet Medyczny im. Piastów Śląskich we Wrocławiu Katedra i | Wroclaw | 50-367 | Poland |
| National University Hospital, Main Building | Singapore | 119228 | Singapore |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| Univerzitná Nemocnica Bratislava-Nemocnica sv. Cyrila a Metoda | Bratislava | 851 07 | Slovakia |
| The Medical Oncology Centre of Rosebank | Johannesburg | Gauteng | 2196 | South Africa |
| Department of Medical Oncology, University of Pretoria and Steve Biko | Pretoria | Gauteng | 0002 | South Africa |
| Groenkloof Life hospital. | Pretoria | Gauteng | 0181 | South Africa |
| Department of Haematology | Cape Town | Western Cape | 7935 | South Africa |
| Hallym University Sacred Heart Hospital | Anyang-si | 14068 | South Korea |
| Dong A University Hospital | Busan | 49201 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 41931 | South Korea |
| Chonbuk National University Hospital | Jeonju | 54907 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Seoul St. Mary's Hospital of the Catholic University of Korea | Seoul | 06591 | South Korea |
| Hospital (Universitari(o)) Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario La Princesa | Madrid | Málaga | 28006 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clínic | Barcelona | 08036 | Spain |
| Hospital Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Virgen de la Salud | Toledo | 45004 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| Linköping University Hospital | Linköping | SE-581 85 | Sweden |
| Skåne University Hospital | Lund | SE-221 85 | Sweden |
| Karolinska University Hospital Solna | Stockholm | SE-171 76 | Sweden |
| Norrlands University Hospital | Umeå | SE-901 85 | Sweden |
| Akademiska Hospital | Uppsala | SE-751 85 | Sweden |
| China Medical University Hospital | Taichung | R.o.c. | 40447 | Taiwan |
| Chi-Mei Medical Center | Tainan | R.o.c. | 710 | Taiwan |
| Mackay Memorial Hospital | Taipei | R.o.c. | 10449 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan |
| Division of Hematology, Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital | Muang | Chiang Mai | 50200 | Thailand |
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| Phramongkutklao Hospital | Bangkok | 10400 | Thailand |
| Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital | Bangkok | 10700 | Thailand |
| MI "Cherkasy Regional Oncological Dispensary " of Cherkasy Regional Council | Cherkasy | 18009 | Ukraine |
| Regional Clinical Hospital in Ivano-Frankivsk, Hematology Department | Ivano-Frankivsk | 76008 | Ukraine |
| Khmelnytskyi Regional Hospital, Hematology Department | Khmelnytskyi | 29000 | Ukraine |
| State Institution "National research center for radiation medicine of NAMS of Ukraine", | Kyiv | 03115 | Ukraine |
| State Institution "National research center for radiation medicine of NAMS of Ukraine" | Kyiv | 03115 | Ukraine |
| transplantation department of hemotology and transplantology division within Clinical Radiology | Kyiv | 03115 | Ukraine |
| Chair of internal medicine #2. | Kyiv | 04112 | Ukraine |
| Kyiv City Clinical Hospital #9, Hematology department #1, | Kyiv | 04112 | Ukraine |
| State Institution "Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine" | Lviv | 79044 | Ukraine |
| Catherine Lewis Centre, Hammersmith Hospital | London | Greater London | W12 0HS | United Kingdom |
| Linda McCartney Centre | Liverpool | Merseyside | L7 8XP | United Kingdom |
| Department of Clinical Haematology | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
| Cancer & Haematology Centre, Churchill Hospital | Oxford | Oxfordshire | OX3 7LE | United Kingdom |
| Department of Haematology The Royal Hallamshire Hospital | Sheffield | South Yorkshire | S10 2JF | United Kingdom |
| Heartlands Hospital | Birmingham | WEST Midlands | B9 5SS | United Kingdom |
| St James's Institute of Oncology | Leeds | WEST Yorkshire | LS9 7TF | United Kingdom |
| Department of Haematology | Cardiff | CF14 4XW | United Kingdom |
| The Hope Clinical Trials Facility | Leicester | LE1 5WW | United Kingdom |
| 35235189 | Derived | Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2. |
| 33851349 | Derived | Chuah C, Koh LP, Numbenjapon T, Zang DY, Ong KH, Do YR, Ohkura M, Ono C, Viqueira A, Cortes JE, Brummendorf TH. Efficacy and safety of bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial. Int J Hematol. 2021 Jul;114(1):65-78. doi: 10.1007/s12185-021-03144-4. Epub 2021 Apr 13. |
| 29091516 | Derived | Cortes JE, Gambacorti-Passerini C, Deininger MW, Mauro MJ, Chuah C, Kim DW, Dyagil I, Glushko N, Milojkovic D, le Coutre P, Garcia-Gutierrez V, Reilly L, Jeynes-Ellis A, Leip E, Bardy-Bouxin N, Hochhaus A, Brummendorf TH. Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial. J Clin Oncol. 2018 Jan 20;36(3):231-237. doi: 10.1200/JCO.2017.74.7162. Epub 2017 Nov 1. |
| FG001 | Imatinib | Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. |
| Treated |
|
| mITT Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat population: All randomized participants with study drug assignments designated according to initial randomization.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bosutinib | Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. |
| BG001 | Imatinib | Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. |
| BG002 | Total | Total of all reporting groups |
| 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 | Percentage of Participants With Major Molecular Response (MMR) at Month 12 | MMR was defined as a ratio of breakpoint cluster region to abelson (BCR-ABL/ABL) less than or equal to (<=) 0.1 percent (%) on the international scale (IS) (greater than or equal to [>=] 3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts [>=3000 ABL required]) by quantitative reverse transcriptase polymerase chain reaction (RT-qPCR). The percentage of participants with MMR at Month 12 are reported. | Modified intent-to-treat (mITT) population included all randomized participants with Philadelphia chromosome positive (Ph+) CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies greater than (>) 0 with study drug assignment designated according to initial randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Major Molecular Response (MMR) Up to Month 18 | MMR was defined as a ratio of BCR-ABL/ABL <=0.1% on the international scale (>=3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts [>=3000 ABL required]) by quantitative RT-qPCR. The percentage of participants with MMR for up to Month 18 are reported. | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies >0 with study drug assignment designated according to initial randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to Month 18 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Probability of Retaining Major Molecular Response (MMR) at Month 48 | The Kaplan-Meier curve was generated based on the first date of MMR until the date of the confirmed loss of MMR or censoring, objectively documented, for responders only. Confirmed loss of MMR was BCR-ABL/ABL IS ratio >0.1% in association with a >=5-fold increase in BCR-ABL/ABL IS ratio from the lowest value achieved up to that time-point confirmed by a second assessment at least 28 days later. Treatment discontinuation due to suboptimal response/treatment failure, progressive disease (PD) or death due to PD within 28 days of last dose were considered confirmed loss of MMR. PD was defined as disease progression to accelerated phase (AP) or blast phase (BP) CML. | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies >0 with study drug assignment designated according to initial randomization and who achieved MMR (responders). Here, "Overall number of Participants Analyzed (N)" signifies number of participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Cytogenetic Response (CCyR) Up to Month 12 | Complete Cytogenetic Response (CCyR) was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow (BM) aspirate. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. The percentage of participants with CCyR for up to Month 12 are reported. | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies >0 with study drug assignment designated according to initial randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to Month 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Kaplan-Meier Estimate of Probability of Retaining Complete Cytogenetic Response (CCyR) at Month 48 | The Kaplan-Meier curve was generated based on the first date of CCyR until the date of the confirmed loss of CCyR or censoring, objectively documented, for responders only. Confirmed loss of CCyR was the presence of at least one Ph+ metaphase confirmed by a second assessment at least 28 days later. Treatment discontinuation due to suboptimal response/treatment failure, PD or death due to PD within 28 days of last dose were considered confirmed loss of CCyR. PD was defined as disease progression to AP or BP CML. | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies >0 with study drug assignment designated according to initial randomization and who achieved CCyR (responders). Here, "N" signifies number of participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 48 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Event Free Survival (EFS) Events | EFS was defined as time from randomization to death due to any cause, transformation to AP or BP at any time, confirmed loss of complete hematologic response (CHR), confirmed loss of CCyR or censoring. Loss of CHR was defined as a hematologic assessment of non-CHR (chronic phase, AP, or BP) confirmed by 2 assessments at least 4 weeks apart. Loss of CHR was defined as appearance of any of the following: WBC count that rises to >20.0*10^9/L, platelet count rises to >=600*10^9/L, appearance of palpable spleen or other extramedullary involvement proven by biopsy, appearance of 5% myelocytes in peripheral blood, appearance of blasts or promyelocytes in peripheral blood. Loss of CCyR was defined as at least 1 Ph+ metaphase from analysis of <100 metaphases confirmed by follow up cytogenetic analysis after 1 month. Cumulative incidence of EFS was defined as percentage of participants with EFS event at Month 60 and was adjusted for competing risk of treatment discontinuation without event. | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies >0 with study drug assignment designated according to initial randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to Month 60 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) Rate | OS was defined as the time (in months) from randomization to the occurrence of death due to any cause or censoring. Kaplan-meier analysis was used for determination of OS. Percentage of participants who were alive were estimated in this outcome measure. | mITT population included all randomized participants with Ph+ CML harboring the b2a2 and/or b3a2 transcript and baseline BCR-ABL copies >0 with study drug assignment designated according to initial randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to Month 60 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Summary of Trough Plasma Concentration by Complete Cytogenetic Response (CCyR) of Bosutinib | CCyR was based on the prevalence of Ph+ metaphases among cells in metaphase on a BM aspirate. CCyR was achieved when there was 0% Ph+ metaphases among cells in a BM sample when at least 20 metaphases from a BM sample were analyzed, or MMR if no BM was available. Trough plasma concentration of participants who had CCyR are presented in this outcome measure. | Pharmacokinetic (PK) population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, "N" signifies number of participants evaluable for this outcome measure and "number analyzed (n)" signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Pre-dose on Days 28, 56 and 84 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Summary of Trough Plasma Concentration by Major Molecular Response (MMR) of Bosutinib | MMR was defined as a ratio of BCR-ABL/ABL <=0.1% on the international scale (>=3 log reduction from standardized baseline in ratio of BCR-ABL to ABL transcripts) by quantitative RT-qPCR. Trough plasma concentration of participants who had MMR are presented in this outcome measure. | PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, "N" signifies number of participants evaluable for this outcome measure and "n" signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose on Days 28, 56 and 84 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Summary of Trough Plasma Concentration by Presence of Grade 1 or Higher Adverse Events (AEs) of Bosutinib | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening or disabling; urgent intervention indicated; Grade 5= death. Trough plasma concentration of participants who had grade 1 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separately for each preferred term of AE. | PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, "N" signifies number of participants evaluable for this outcome measure and "n" signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose on Days 28, 56 and 84 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Summary of Trough Plasma Concentration by Presence of Grade 3 or Higher Adverse Events (AEs) of Bosutinib | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on NCI CTCAE version 4.0. Grade 1= mild; Grade 2= moderate; within normal limits, Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= life-threatening or disabling; urgent intervention indicated; Grade 5= death. Trough plasma concentration of participants who had grade 3 or higher AE are presented in this outcome measure. Data of plasma concentration is reported separately for each preferred term of AE. | PK population included all enrolled participants who received at least 1 dose of bosutinib and had sufficient plasma results available. Here, "N" signifies number of participants evaluable for this outcome measure and "n" signifies participants evaluable at specified time points only. Data for this outcome measure was not planned to be collected and analyzed for Imatinib arm as pre-specified in the protocol. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose on Days 28, 56 and 84 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Vital Signs Abnormalities | Criteria for vital signs abnormalities: systolic blood pressure <80 millimeter of mercury (mmHg), >210 mmHg; diastolic blood pressure <40 mmHg, >130 mmHg; heart rate <40 beats per minute (bpm), >150 bpm; temperature <32 degree celsius, >40 degree celsius; weight >=10% increase from baseline, >=10% decrease from baseline. The number of participants with any vital sign abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article until the last date of test article +28 days. | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. Here, "N" signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to end of treatment (up to Month 60) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) Version 4.03 | Laboratory parameters included hematological (haemoglobin, lymphocytes [absolute], neutrophils [absolute], platelets and leukocytes) and biochemistry (albumin, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, amylase, bilirubin, creatinine kinase, calcium, creatinine, glucose, potassium, lipase, magnesium, phosphate, sodium, urate) parameters. Abnormalities in laboratory tests were graded by NCI CTCAE version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. The number of participants with laboratory test abnormalities were reported. | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. | Posted | Count of Participants | Participants | Baseline up to end of treatment (up to Month 60) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Criteria for ECG abnormalities included heart rate: increase of >15 bpm from baseline value and >=120 bpm, decrease of >15 bpm from baseline value and <=45 bpm; PR interval: change of >=20 msec from baseline value and >=220 milliseconds (msec); QRS interval >=120 msec; QTcB interval >500 msec, increase of >60 msec from baseline; >450 msec (Men) or >470 msec (Women). QT interval using Fridericia's correction (QTcF) >500 msec, increase of >60 msec from baseline, >450 msec (Men) or >470 msec (Women). The number of participants with ECG abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article up until the last date of test article +28 days. | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. Here, "N" signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to end of treatment (up to Month 60) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Adverse Events (AEs) Leading to Study Drug Discontinuation | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. | Posted | Count of Participants | Participants | Baseline up to end of treatment (up to Month 60) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events by National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.0) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE version 4.0. Grade 1 =mild; Grade 2 =moderate; Grade 3 =severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4 =life-threatening or disabling, urgent intervention indicated; Grade 5 =death. Treatment-emergent events were events between first dose of study drug and up to 60 months that were absent before treatment that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 adverse event, only the maximum CTCAE was reported. | Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received. | Posted | Count of Participants | Participants | Baseline up to end of treatment (up to Month 60) |
|
From first dose of drug up to 28 days after last dose (up to Month 60)
All-cause mortality: The total number of deaths occurred during study (from randomization and up to month 60) are reported for all randomized participants, not only for treated participants, and included deaths which occurred after 28 days post last study drug dose. Serious AEs and other AEs: Analysis performed on safety population. The safety population included all participants, regardless of Philadelphia chromosome or transcript status, who received at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bosutinib | Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. | 14 | 268 | 98 | 268 | 264 | 268 |
| EG001 | Imatinib | Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. | 14 | 268 | 68 | 265 | 260 | 265 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pleuropericarditis | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Thyroid disorder | Endocrine disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Retinopathy | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Necrotising oesophagitis | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Oedematous pancreatitis | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Implant site haematoma | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Swelling face | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Candida pneumonia | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fournier's gangrene | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Infective pericardial effusion | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Meningococcal sepsis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Oropharyngitis fungal | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Splenic infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bladder papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Carcinoid tumour of the caecum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Endometrial cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fallopian tube cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fibromatosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Unintended pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v23.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Prostatic dysplasia | Reproductive system and breast disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pregnancy of partner | Social circumstances | MedDRA v23.0 | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v23.0 | 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 |
|---|---|
| D007938 | Leukemia |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D007951 | Leukemia, Myeloid |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D010677 | Philadelphia Chromosome |
| D009370 | Neoplasms by Histologic Type |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D014178 | Translocation, Genetic |
| D010335 | Pathologic Processes |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002869 | Chromosome Aberrations |
Not provided
Not provided
| ID | Term |
|---|---|
| C471992 | bosutinib |
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided
| Male |
|
95% Confidence Interval (CI) for the odds ratio adjusted for sokal risk group and region are based on Mantel-Haenszel confidence limits.
| Superiority |
|
|
|
| OG001 | Imatinib | Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. |
|
|
|
|
|
|
Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
|
|
|
| OG001 | Imatinib | Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. |
|
|
| OG001 |
| Imatinib |
Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 |
| Imatinib |
Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. |
|
|