Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL)
Official Title
A Pivotal Phase 2 Trial of Ponatinib (AP24534) in Patients With Refractory Chronic Myeloid Leukemia and Ph+ Acute Lymphoblastic Leukemia
Acronym
PACE
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Jan 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 30, 2010Actual
Primary Completion Date
Dec 20, 2018Actual
Completion Date
Jan 17, 2019Actual
First Submitted Date
Sep 20, 2010
First Submission Date that Met QC Criteria
Sep 22, 2010
First Posted Date
Sep 23, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 19, 2019
Results First Submitted that Met QC Criteria
Jan 17, 2020
Results First Posted Date
Jan 29, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 18, 2021
Last Update Posted Date
Feb 2, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Ariad PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the (T)hreonine-315-(I)soleucine (T315I) mutation.
Detailed Description
The preliminary analysis of the phase 1 clinical trial revealed evidence of clinical antitumor activity in patients with resistance to approved second-generation tyrosine kinase inhibitors (TKI), dasatinib and nilotinib, including patients with the T315I mutation of the BCR-ABL gene (BCR-ABL). This Phase 1 study, taken together with the strong preclinical data that characterize ponatinib, provides the rationale for moving to a pivotal phase 2 trial of this agent in a population of patients with chronic myeloid leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL) who are resistant or intolerant to prior TKI therapy and in those patients with the T315I mutation.
PACE is a multi-center, international, phase 2, uncontrolled, open-label trial of oral ponatinib in patients with Philadelphia chromosome-positive (Ph+) disease. The study enrolled 449 patients. Participants assigned to 1 of 6 cohorts in accordance with disease group and received:
Ponatinib 45 mg
This multi-center trial is conducted worldwide. The overall time to participate in this study is 96 months after last dose of study drug treatment.
Conditions Module
Conditions
Chronic Myeloid Leukemia
Ph+ Acute Lymphoblastic Leukemia
Keywords
CML
ALL
PH
ponatinib
Ph+ALL
T315I mutation
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
449Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort A: CP-CML R-I
Experimental
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Drug: Ponatinib
Cohort B: CP-CML with T315I Mutation
Experimental
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Drug: Ponatinib
Cohort C: Accelerated Phase (AP)-CML R-I
Experimental
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Drug: Ponatinib
Cohort D: AP-CML with T315I Mutation
Experimental
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ponatinib
Drug
Ponatinib tablets.
Cohort A: CP-CML R-I
Cohort B: CP-CML with T315I Mutation
Cohort C: Accelerated Phase (AP)-CML R-I
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of CP-CML Participants With Major Cytogenetic Response (MCyR)
MCyR is defined as percentage of participants with complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Cytogenetic response is the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow (BM). Response is further defined as MCyR: CCyR or PCyR, where CCyR: no Ph+ cells; PCyR: 1 to 35% Ph+ cells.
Up to 12 months after initiation of study treatment
Percentage of AP-CML Participants With Major Hematologic Response (MaHR)
MaHR is defined as percentage of participants with complete hematologic response (CHR) or no evidence of leukemia (NEL). Response criteria for CHR is reported as white blood cells (WBC)≤institutional upper limit of normal, absolute neutrophil count (ANC)≥1000/mm^3, platelets≥100,000/mm^3, no blasts or promyelocytes in peripheral blood, BM blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement; Response criteria for NEL is reported as WBC≤institutional upper limit of normal, no blasts or promyelocytes in peripheral blood, BM blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement, at least 1 of the following: (i) 20,000/mm^3≤platelets<100,000/mm^3; (ii) 500/mm^3≤ANC<1000/mm^3.
Up to 6 months after initiation of study treatment
Percentage of BP-CML/Ph+ ALL Participants With MaHR
MaHR is defined as percentage of participants with CHR or NEL. Response criteria for CHR is reported as WBC≤institutional upper limit of normal, ANC≥1000/mm^3, platelets ≥100,000/mm^3, no blasts or promyelocytes in peripheral blood, BM blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement; Response criteria for NEL is reported as WBC≤ institutional upper limit of normal, no blasts or promyelocytes in peripheral blood, BM blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement, at least 1 of the following: (i) 20,000/mm^3 ≤platelets<100,000/mm^3; (ii) 500/mm^3≤ANC<1000/mm^3.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of CP-CML Participants With CHR
Response criteria for CHR is reported as WBC≤institutional upper limit of normal, platelets<450,000/mm^3, no blasts or promyelocytes in peripheral blood, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement (including no hepatomegaly or splenomegaly).
Every 3 cycles up to 39 cycles, followed by every subsequent sixth cycle (Up to approximately 48 months after first dose)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must have CML in any phase (CP, AP, or BP of any phenotype) or Ph+ ALL
Previously treated with and developed resistance or intolerance to dasatinib or nilotinib OR developed the T3151 mutation after any tyrosine kinase inhibitor (TKI) therapy
≥18 years old
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Minimum life expectancy of ≥3 months
Adequate kidney function
Adequate liver function
Normal pancreatic function
Normal QT Fridericia-corrected interval (QTcF) ≤450 ms for males and ≤470 ms for females
Negative pregnancy test (if woman of childbearing potential)
Agree to use effective form of contraception (as applicable)
Ability to comply with study procedures, in the Investigator's opinion
Exclusion Criteria:
Received prior TKI treatment within 7 days prior to receiving the first dose of ponatinib, or have not recovered from adverse events (except alopecia) due to agents previously administered.
Received other therapies as follows:
For CML chronic phase (CP) and accelerated phase (AP) participants, received hydroxyurea or anagrelide within 24 hours prior to receiving the first dose of ponatinib; interferon, cytarabine, or immunotherapy within 14 days prior to first dose of ponatinib; or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of ponatinib.
For CML blast phase (BP) participants, received chemotherapy within 14 days prior to the first dose of ponatinib.
For Ph+ ALL participants, received corticosteroids within 24 hours before the first dose of ponatinib; or vincristine within 7 days prior to the first dose of ponatinib; or received other chemotherapy within 14 days prior to the first dose of ponatinib.
Underwent stem cell transplant <60 days prior to receiving first dose of ponatinib
Evidence of on-going graft versus-host disease (GVHD), or GVHD requiring immunosuppressive therapy
Taking medications that are known to be associated with Torsades de Pointes
Require concurrent treatment with immunosuppressive agents (other than corticosteroids prescribed for a short course of therapy)
Previously treated with ponatinib
CML CP participants are excluded if they are in Complete cytogenetic response (CCyR)
Participants with CML AP, CML BP, or Ph+ ALL are excluded if they are in Major Hematologic Response (MaHR).
Have active Central Nervous System (CNS) disease
Have significant or active cardiovascular disease
Have a significant bleeding disorder unrelated to CML or Ph+ALL
Have a history of pancreatitis or alcohol abuse
Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
Have malabsorption syndrome or other gastrointestinal illness that could affect absorption of ponatinib
Diagnosed with another primary malignancy in the past 3 years
Pregnant or lactating
Underwent major surgery within 14 days prior to first dose of ponatinib
Have ongoing or active infection
Suffer from any other condition or illness that would compromise safety or interfere with evaluation of the drug
Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre PD, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Muller MC, Gambacorti-Passerini C, Lustgarten S, Rivera VM, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes TP, Shah NP, Kantarjian HM. Ponatinib efficacy and safety in Philadelphia chromosome-positive leukemia: final 5-year results of the phase 2 PACE trial. Blood. 2018 Jul 26;132(4):393-404. doi: 10.1182/blood-2016-09-739086. Epub 2018 Mar 22.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Not provided
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants were assigned to 1 of 6 cohorts: chronic myeloid leukemia (CML) in chronic (CP), accelerated (AP), or blast phase (BP), or with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) who were resistant or intolerant (R-I) to either dasatinib or nilotinib or had (T)hreonine-315-(I)soleucine (T315I) mutation.
Recruitment Details
Participants took part in the study at 66 investigative sites in the Australia, Belgium, Canada, France, Germany, Italy, the Netherlands, Republic of Korea, Singapore, Spain, Sweden, the United Kingdom and the United States from 30 September 2010 to 17 January 2019.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A: CP-CML R-I
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
SAP
No
Yes
No
Statistical Analysis Plan
Dec 14, 2010
Dec 19, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Canada
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Ponatinib
Cohort E: Blast Phase (BP)-CML/Ph+ ALL R-I
Experimental
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Drug: Ponatinib
Cohort F: BP-CML or Ph+ ALL with T315I Mutation
Experimental
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Drug: Ponatinib
Unassigned to Cohorts A-F
Experimental
Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not R-I to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Drug: Ponatinib
Cohort D: AP-CML with T315I Mutation
Cohort E: Blast Phase (BP)-CML/Ph+ ALL R-I
Cohort F: BP-CML or Ph+ ALL with T315I Mutation
Unassigned to Cohorts A-F
AP24534
Iclusig
Up to 6 months after initiation of study treatment
Percentage of CP-CML Participants With Confirmed MCyR
Confirmed MCyR is defined as 2 assessments of CCyR or PCyR at least 28 days apart. For CP participants entering the trial in PCyR, confirmed MCyR is defined as 2 assessments of CCyR at least 28 days apart.
Every 3 cycles up to 39 cycles, followed by every subsequent sixth cycle (Up to approximately 48 months after first dose)
Percentage of CP-CML Participants With Major Molecular Response (MMR)
MMR is defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL ≤0.1% on the international scale (equivalent to a 3-log reduction in transcript).
Every 3 cycles up to 39 cycles, followed by every subsequent sixth cycle (Up to approximately 48 months after first dose)
Percentage of AP-CML or BP-CML/Ph+ ALL Participants With MCyR
MCyR is defined as percentage of participants with CCyR or PCyR. Cytogenetic response is the percentage of Ph+ metaphases in BM. Response is further defined as MCyR: CCyR or PCyR, where CCyR: no Ph+ cells; PCyR: 1 to 35% Ph+ cells.
Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)
Percentage of AP-CML or BP-CML/Ph+ ALL Participants With Confirmed MCyR
Confirmed MCyR is defined as 2 assessments of CCyR or PCyR at least 28 days apart.
Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)
Percentage of AP-CML or BP-CML/Ph+ ALL Participants With MMR
MMR is defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL ≤0.1% on the international scale (equivalent to a 3-log reduction in transcript).
Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)
Time to Response
Time to response is defined as the interval from the first dose of study treatment until the criteria for response are first met, censored at the last assessment of response. Median time to response was estimated using the Kaplan-Meier method.
Up to approximately 48 months after first dose
Duration of Response
Duration of Response is defined as the interval between the first assessment at which the criteria for response are met until the criteria for progression are met, censored at the last date at which the criteria for response are met. Duration of response was estimated by the Kaplan-Meier method as the probability of remaining in response.
Up to approximately 48 months after first dose
Progression-free Survival (PFS)
PFS is defined as the interval from the first dose of study treatment until the criteria for progression or death are met, censored at the last response assessment. Progression from CP is reported as death, development of AP or BP, loss of CHR (in the absence of cytogenetic response), confirmed by development in complete blood counts (CBCs) at least 4 weeks apart, loss of MCyR, increasing WBC in participant without CHR defined by doubling of WBC to >20K on 2 occasions at least 4 weeks apart; Progression from AP is reported as death, development of confirmed BP, loss of previous major or minor hematologic response over a 2-week period, no decrease from baseline levels in percentage blasts in peripheral blood or BM on all assessments over a 4-week period; Progression from BP or Ph+ ALL is reported as death, increasing blasts in peripheral blood or BM over a 4 week period.
Every 12 weeks ± 2 weeks from last dose of study drug or the investigator/participant decision to discontinue treatment, whichever occurred later (Up to approximately 96 months after last dose)
Overall Survival (OS)
OS is defined as the interval from the first dose of study treatment until death, censored at the last date at which participant was known to be alive.
From the first dose of study treatment until death (Up to 96 months post last dose)
Number of Participants With Treatment-Emergent Adverse Event (TEAE) and Serious AE (SAE)
An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.
From first dose up to 30 days after last dose of the study drug (Up to approximately 49 months)
Januzzi JL, Garasic JM, Kasner SE, McDonald V, Petrie MC, Seltzer J, Mauro M, Croce K, Berman E, Deininger M, Hochhaus A, Pinilla-Ibarz J, Nicolini F, Kim DW, DeAngelo DJ, Kantarjian H, Xu J, Hall T, Srivastava S, Naranjo D, Cortes J. Retrospective analysis of arterial occlusive events in the PACE trial by an independent adjudication committee. J Hematol Oncol. 2022 Jan 6;15(1):1. doi: 10.1186/s13045-021-01221-z.
Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre P, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, DiPersio J, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Muller MC, Gambacorti-Passerini C, Wong S, Lustgarten S, Rivera VM, Clackson T, Turner CD, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes T, Goldman JM, Shah NP, Kantarjian H; PACE Investigators. A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med. 2013 Nov 7;369(19):1783-96. doi: 10.1056/NEJMoa1306494. Epub 2013 Nov 1.
O'Hare T, Zabriskie MS, Eiring AM, Deininger MW. Pushing the limits of targeted therapy in chronic myeloid leukaemia. Nat Rev Cancer. 2012 Jul 24;12(8):513-26. doi: 10.1038/nrc3317.
Cohort B: CP-CML With T315I Mutation
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
FG002
Cohort C: AP-CML R-I
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
FG003
Cohort D: AP-CML With T315I Mutation
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
FG004
Cohort E: BP-CML/Ph+ ALL R-I
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
FG005
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
FG006
Unassigned to Cohorts A-F
Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not resistant or intolerant to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
FG000203 subjects
FG00164 subjects
FG00265 subjects
FG00318 subjects
FG00448 subjects
FG00546 subjects
FG0065 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG000203 subjects
FG00164 subjects
FG00265 subjects
FG00318 subjects
FG00448 subjects
FG00546 subjects
FG0065 subjects
Type
Comment
Reasons
Adverse Event
FG00046 subjects
FG00111 subjects
FG0027 subjects
FG0032 subjects
FG0046 subjects
FG0056 subjects
FG0062 subjects
Death
FG0006 subjects
FG0013 subjects
FG0022 subjects
FG0032 subjects
FG004
Lack of Efficacy
FG00013 subjects
FG0012 subjects
FG0025 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Non-compliance with Study Drug
FG0003 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Physician Decision
FG0006 subjects
FG0015 subjects
FG0025 subjects
FG0030 subjects
FG004
Progressive Disease
FG00019 subjects
FG00110 subjects
FG00219 subjects
FG0037 subjects
FG004
Protocol Violation
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Site Terminated by Sponsor
FG00069 subjects
FG00119 subjects
FG00212 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG00029 subjects
FG0014 subjects
FG0025 subjects
FG0033 subjects
FG004
Reason Not Specified
FG00010 subjects
FG00110 subjects
FG0027 subjects
FG0030 subjects
FG004
The safety population included all participants who received at least 1 dose of ponatinib.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A: CP-CML R-I
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
BG001
Cohort B: CP-CML With T315I Mutation
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
BG002
Cohort C: AP-CML R-I
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
BG003
Cohort D: AP-CML With T315I Mutation
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
BG004
Cohort E: BP-CML/Ph+ ALL R-I
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
BG005
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
BG006
Unassigned to Cohorts A-F
Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not resistant or intolerant to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000203
BG00164
BG00265
BG00318
BG00448
BG00546
BG0065
BG007449
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG00164
ParticipantsBG00265
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG00164
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG00164
ParticipantsBG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG00164
ParticipantsBG002
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG-PS measured on-therapy assessed participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (>50% of waking hrs), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair >50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.
1 participant from the cohort F had missing ECOG data.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG001
Time From Diagnosis to First Dose
Median
Full Range
years
Title
Denominators
Categories
ParticipantsBG000203
ParticipantsBG00164
ParticipantsBG002
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 CP-CML Participants With Major Cytogenetic Response (MCyR)
MCyR is defined as percentage of participants with complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Cytogenetic response is the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow (BM). Response is further defined as MCyR: CCyR or PCyR, where CCyR: no Ph+ cells; PCyR: 1 to 35% Ph+ cells.
Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts A and B only.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 12 months after initiation of study treatment
ID
Title
Description
OG000
Cohort A: CP-CML R-I
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG001
Cohort B: CP-CML With T315I Mutation
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Units
Counts
Participants
OG000203
OG00164
Title
Denominators
Categories
Title
Measurements
OG00050.7(43.6 to 57.8)
OG00170.3(57.6 to 81.1)
Primary
Percentage of AP-CML Participants With Major Hematologic Response (MaHR)
MaHR is defined as percentage of participants with complete hematologic response (CHR) or no evidence of leukemia (NEL). Response criteria for CHR is reported as white blood cells (WBC)≤institutional upper limit of normal, absolute neutrophil count (ANC)≥1000/mm^3, platelets≥100,000/mm^3, no blasts or promyelocytes in peripheral blood, BM blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement; Response criteria for NEL is reported as WBC≤institutional upper limit of normal, no blasts or promyelocytes in peripheral blood, BM blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement, at least 1 of the following: (i) 20,000/mm^3≤platelets<100,000/mm^3; (ii) 500/mm^3≤ANC<1000/mm^3.
Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts C and D only.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 6 months after initiation of study treatment
ID
Title
Description
OG000
Cohort C: AP-CML R-I
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG001
Cohort D: AP-CML With T315I Mutation
Primary
Percentage of BP-CML/Ph+ ALL Participants With MaHR
MaHR is defined as percentage of participants with CHR or NEL. Response criteria for CHR is reported as WBC≤institutional upper limit of normal, ANC≥1000/mm^3, platelets ≥100,000/mm^3, no blasts or promyelocytes in peripheral blood, BM blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement; Response criteria for NEL is reported as WBC≤ institutional upper limit of normal, no blasts or promyelocytes in peripheral blood, BM blasts ≤5%, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement, at least 1 of the following: (i) 20,000/mm^3 ≤platelets<100,000/mm^3; (ii) 500/mm^3≤ANC<1000/mm^3.
Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts E and F only.
Posted
Number
95% Confidence Interval
percentage of participants
Up to 6 months after initiation of study treatment
ID
Title
Description
OG000
Cohort E: BP-CML/Ph+ ALL R-I
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG001
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
Secondary
Percentage of CP-CML Participants With CHR
Response criteria for CHR is reported as WBC≤institutional upper limit of normal, platelets<450,000/mm^3, no blasts or promyelocytes in peripheral blood, <5% myelocytes plus metamyelocytes in peripheral blood, basophils in peripheral blood <5%, no extramedullary involvement (including no hepatomegaly or splenomegaly).
Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts A and B only.
Posted
Number
95% Confidence Interval
percentage of participants
Every 3 cycles up to 39 cycles, followed by every subsequent sixth cycle (Up to approximately 48 months after first dose)
ID
Title
Description
OG000
Cohort A: CP-CML R-I
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG001
Cohort B: CP-CML With T315I Mutation
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Secondary
Percentage of CP-CML Participants With Confirmed MCyR
Confirmed MCyR is defined as 2 assessments of CCyR or PCyR at least 28 days apart. For CP participants entering the trial in PCyR, confirmed MCyR is defined as 2 assessments of CCyR at least 28 days apart.
Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts A and B only.
Posted
Number
95% Confidence Interval
percentage of participants
Every 3 cycles up to 39 cycles, followed by every subsequent sixth cycle (Up to approximately 48 months after first dose)
ID
Title
Description
OG000
Cohort A: CP-CML R-I
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG001
Cohort B: CP-CML With T315I Mutation
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Secondary
Percentage of CP-CML Participants With Major Molecular Response (MMR)
MMR is defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL ≤0.1% on the international scale (equivalent to a 3-log reduction in transcript).
Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts A and B only.
Posted
Number
95% Confidence Interval
percentage of participants
Every 3 cycles up to 39 cycles, followed by every subsequent sixth cycle (Up to approximately 48 months after first dose)
ID
Title
Description
OG000
Cohort A: CP-CML R-I
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG001
Cohort B: CP-CML With T315I Mutation
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Secondary
Percentage of AP-CML or BP-CML/Ph+ ALL Participants With MCyR
MCyR is defined as percentage of participants with CCyR or PCyR. Cytogenetic response is the percentage of Ph+ metaphases in BM. Response is further defined as MCyR: CCyR or PCyR, where CCyR: no Ph+ cells; PCyR: 1 to 35% Ph+ cells.
Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts C to F only.
Posted
Number
95% Confidence Interval
percentage of participants
Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)
ID
Title
Description
OG000
Cohort C: AP-CML R-I
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG001
Cohort D: AP-CML With T315I Mutation
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Secondary
Percentage of AP-CML or BP-CML/Ph+ ALL Participants With Confirmed MCyR
Confirmed MCyR is defined as 2 assessments of CCyR or PCyR at least 28 days apart.
Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts C to F only.
Posted
Number
95% Confidence Interval
percentage of participants
Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)
ID
Title
Description
OG000
Cohort C: AP-CML R-I
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG001
Cohort D: AP-CML With T315I Mutation
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG002
Cohort E: BP-CML/Ph+ ALL R-I
Secondary
Percentage of AP-CML or BP-CML/Ph+ ALL Participants With MMR
MMR is defined as a ratio of reverse transcribed transcript of BCR-ABL to ABL ≤0.1% on the international scale (equivalent to a 3-log reduction in transcript).
Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. The data for this outcome measure is applicable for Cohorts C to F only.
Posted
Number
95% Confidence Interval
percentage of participants
Every 2 cycles up to 26 cycles, followed by every 3 cycles from cycles 27 through 39, and then every subsequent sixth cycle (Up to approximately 48 months after first dose)
ID
Title
Description
OG000
Cohort C: AP-CML R-I
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG001
Cohort D: AP-CML With T315I Mutation
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG002
Secondary
Time to Response
Time to response is defined as the interval from the first dose of study treatment until the criteria for response are first met, censored at the last assessment of response. Median time to response was estimated using the Kaplan-Meier method.
Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. Median time to response was reported for responders only. Participants who did not achieve the specified response were censored at the last response assessment. Number analyzed: participants with data available at given time-point.
Posted
Median
Full Range
days
Up to approximately 48 months after first dose
ID
Title
Description
OG000
Cohort A: CP-CML R-I
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG001
Cohort B: CP-CML With T315I Mutation
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Secondary
Duration of Response
Duration of Response is defined as the interval between the first assessment at which the criteria for response are met until the criteria for progression are met, censored at the last date at which the criteria for response are met. Duration of response was estimated by the Kaplan-Meier method as the probability of remaining in response.
Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib. Number analyzed is number of participants with data available for analysis at given time-point
Posted
Median
Full Range
days
Up to approximately 48 months after first dose
ID
Title
Description
OG000
Cohort A: CP-CML R-I
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG001
Cohort B: CP-CML With T315I Mutation
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Secondary
Progression-free Survival (PFS)
PFS is defined as the interval from the first dose of study treatment until the criteria for progression or death are met, censored at the last response assessment. Progression from CP is reported as death, development of AP or BP, loss of CHR (in the absence of cytogenetic response), confirmed by development in complete blood counts (CBCs) at least 4 weeks apart, loss of MCyR, increasing WBC in participant without CHR defined by doubling of WBC to >20K on 2 occasions at least 4 weeks apart; Progression from AP is reported as death, development of confirmed BP, loss of previous major or minor hematologic response over a 2-week period, no decrease from baseline levels in percentage blasts in peripheral blood or BM on all assessments over a 4-week period; Progression from BP or Ph+ ALL is reported as death, increasing blasts in peripheral blood or BM over a 4 week period.
Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib.
Posted
Median
95% Confidence Interval
days
Every 12 weeks ± 2 weeks from last dose of study drug or the investigator/participant decision to discontinue treatment, whichever occurred later (Up to approximately 96 months after last dose)
ID
Title
Description
OG000
Cohort A: CP-CML R-I
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG001
Secondary
Overall Survival (OS)
OS is defined as the interval from the first dose of study treatment until death, censored at the last date at which participant was known to be alive.
Treated population included all participants assigned to Cohorts A to F who received at least 1 dose of ponatinib.
Posted
Median
95% Confidence Interval
days
From the first dose of study treatment until death (Up to 96 months post last dose)
ID
Title
Description
OG000
Cohort A: CP-CML R-I
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG001
Cohort B: CP-CML With T315I Mutation
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG002
Cohort C: AP-CML R-I
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Secondary
Number of Participants With Treatment-Emergent Adverse Event (TEAE) and Serious AE (SAE)
An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy.
The safety population included all participants who received at least 1 dose of ponatinib.
Posted
Count of Participants
Participants
From first dose up to 30 days after last dose of the study drug (Up to approximately 49 months)
ID
Title
Description
OG000
Cohort A: CP-CML R-I
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Time Frame
SAEs and Other AEs: From first dose up to 30 days after last dose of the study drug (Up to approximately 49 months); All-Cause Mortality: Up to approximately 8 years
Description
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort A: CP-CML R-I
CP-CML participants R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
41
203
132
203
203
203
EG001
Cohort B: CP-CML With T315I Mutation
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
18
64
39
64
64
64
EG002
Cohort C: AP-CML R-I
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
30
65
44
65
65
65
EG003
Cohort D: AP-CML With T315I Mutation
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
9
18
13
18
18
18
EG004
Cohort E: BP-CML/Ph+ ALL R-I
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
40
48
41
48
48
48
EG005
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
39
46
37
46
46
46
EG006
Unassigned AP/CP-CML
Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not R-I to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
2
5
3
5
5
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pancreatitis
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG00010 affected203 at risk
EG0014 affected64 at risk
EG0023 affected65 at risk
EG0030 affected18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0007 affected203 at risk
EG0011 affected64 at risk
EG0024 affected65 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0003 affected203 at risk
EG0011 affected64 at risk
EG0021 affected65 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0011 affected64 at risk
EG0021 affected65 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0021 affected65 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG00011 affected203 at risk
EG0014 affected64 at risk
EG0020 affected65 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
Two treatment-emergent deaths (1-Cohort B, 1-Cohort E) occurred during treatment with ponatinib and are not related.
EG0005 affected203 at risk
EG0013 affected64 at risk
EG0021 affected65 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0004 affected203 at risk
EG0016 affected64 at risk
EG0021 affected65 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort A and is related.
EG0002 affected203 at risk
EG0011 affected64 at risk
EG0021 affected65 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG00010 affected203 at risk
EG0014 affected64 at risk
EG0020 affected65 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
Four treatment-emergent deaths (2-Cohort A, 1-Cohort B, 1-Cohort F) occurred during treatment with ponatinib and one in Cohort F is related.
EG0002 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Atrial tachycardia
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0003 affected203 at risk
EG0011 affected64 at risk
EG0021 affected65 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 19.0
Systematic Assessment
Two treatment-emergent deaths occurred during treatment with ponatinib in Cohort A and one is related.
EG00010 affected203 at risk
EG0015 affected64 at risk
EG0028 affected65 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0004 affected203 at risk
EG0011 affected64 at risk
EG0022 affected65 at risk
EG003
Sepsis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
Three treatment-emergent deaths (1-Cohort D, 1-Cohort E, 1-Cohort F) occurred during treatment with ponatinib and are not related.
EG0002 affected203 at risk
EG0011 affected64 at risk
EG0022 affected65 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0005 affected203 at risk
EG0012 affected64 at risk
EG0020 affected65 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Herpes oesophagitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Wound infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Lipase increased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0004 affected203 at risk
EG0013 affected64 at risk
EG0021 affected65 at risk
EG003
Platelet count decreased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0022 affected65 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0003 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0022 affected65 at risk
EG003
Pyrexia
General disorders
MedDRA version 19.0
Systematic Assessment
EG0005 affected203 at risk
EG0013 affected64 at risk
EG0025 affected65 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA version 19.0
Systematic Assessment
EG0004 affected203 at risk
EG0011 affected64 at risk
EG0022 affected65 at risk
EG003
Asthenia
General disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Chest pain
General disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Chills
General disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pain
General disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0012 affected64 at risk
EG0020 affected65 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
Twenty-four treatment-emergent deaths (4-Cohort A, 1-Cohort B, 2-Cohort C, 2-Cohort D, 10-Cohort E, 5 Cohort F) occurred during treatment with ponatinib and are not related.
EG0006 affected203 at risk
EG0012 affected64 at risk
EG0027 affected65 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0003 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG00011 affected203 at risk
EG0010 affected64 at risk
EG0022 affected65 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort C and is not related.
EG0002 affected203 at risk
EG0011 affected64 at risk
EG0022 affected65 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0004 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Hot flush
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort F and is not related.
EG0003 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort B and is not related.
EG0005 affected203 at risk
EG0014 affected64 at risk
EG0021 affected65 at risk
EG003
Headache
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0012 affected64 at risk
EG0020 affected65 at risk
EG003
Ataxia
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Cerebral artery stenosis
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0012 affected64 at risk
EG0020 affected65 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0005 affected203 at risk
EG0013 affected64 at risk
EG0020 affected65 at risk
EG003
Haemorrhagic cerebral infarction
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort B and is not related.
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Haemorrhagic transformation stroke
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
IVth nerve paralysis
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Subarachnoid haemorrhage
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA version 19.0
Systematic Assessment
EG0007 affected203 at risk
EG0010 affected64 at risk
EG0024 affected65 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Splenic infarction
Blood and lymphatic system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA version 19.0
Systematic Assessment
EG0004 affected203 at risk
EG0011 affected64 at risk
EG0021 affected65 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort E and is not related.
EG0004 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0013 affected64 at risk
EG0021 affected65 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0003 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Peripancreatic fluid collection
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Procedural vomiting
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA version 19.0
Systematic Assessment
EG0003 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Prostatic obstruction
Reproductive system and breast disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Appendicitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0022 affected65 at risk
EG003
Breast cellulitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0003 affected203 at risk
EG0010 affected64 at risk
EG0022 affected65 at risk
EG003
Infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0022 affected65 at risk
EG003
Localised infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Lung infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort D and is related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Septic shock
Infections and infestations
MedDRA version 19.0
Systematic Assessment
Three treatment-emergent deaths (1-Cohort C, 2-Cohort F) occurred during treatment with ponatinib and are not related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Splenic abscess
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Retroperitoneal haematoma
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0022 affected65 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0022 affected65 at risk
EG003
Blast crisis in myelogenous leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
Three treatment-emergent deaths (1-Cohort C, 1-Cohort E, 1-Cohort F) occurred during treatment with ponatinib and are not related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0003 affected203 at risk
EG0010 affected64 at risk
EG0022 affected65 at risk
EG003
Device dislocation
Product Issues
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Cerebellar infarction
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort F and is not related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Migraine
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Somnolence
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0003 affected203 at risk
EG0011 affected64 at risk
EG0022 affected65 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0003 affected203 at risk
EG0013 affected64 at risk
EG0020 affected65 at risk
EG003
Cardiopulmonary failure
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort F and is not related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0022 affected65 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Traumatic intracranial haemorrhage
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort F and is not related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0011 affected64 at risk
EG0021 affected65 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0022 affected65 at risk
EG003
Extremity necrosis
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0011 affected64 at risk
EG0021 affected65 at risk
EG003
Acute febrile neutrophilic dermatosis
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Haemorrhagic ovarian cyst
Reproductive system and breast disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Klebsiella sepsis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Catheter site cellulitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Haematoma infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Otitis externa
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pneumonia respiratory syncytial viral
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Chloroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Hyperviscosity syndrome
Blood and lymphatic system disorders
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort E and is not related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Hyperleukocytosis
Blood and lymphatic system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Unassigned AP/CP-CML and is related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Acute abdomen
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Gastritis haemorrhagic
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort E and is related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Cardiac tamponade
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Right ventricular failure
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Urine analysis abnormal
Investigations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Implant site pain
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort E and is not related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Embolism venous
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Thrombophlebitis superficial
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Delirium
Psychiatric disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Dermatitis exfoliative generalised
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Graft versus host disease in skin
Immune system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pneumonitis chemical
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0011 affected64 at risk
EG0021 affected65 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Acute left ventricular failure
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Aortic valve stenosis
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Arrhythmia supraventricular
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Arteriospasm coronary
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0021 affected65 at risk
EG003
Cardiac Discomfort
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Congestive cardiomyopathy
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Dressler's syndrome
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Ischaemic cardiomyopathy
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0021 affected65 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Sinus node dysfunction
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Left ventricular failure
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Appendicitis Noninfective
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Colitis Ischaemic
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Fistula of small intestine
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Peritoneal haemorrhage
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Mesenteric arterial occlusion
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort E and is related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Impaired healing
General disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Gait disturbance
General disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Oedema peripheral
General disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Vascular stent occlusion
General disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Fatigue
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA version 19.0
Systematic Assessment
Two treatment-emergent deaths (1-Cohort E, 1-Cohort F) occurred during treatment with ponatinib and are not related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Non-alcoholic steatohepatitis
Hepatobiliary disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Venoocclusive liver disease
Hepatobiliary disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Biliary dilatation
Hepatobiliary disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Gallbladder obstruction
Hepatobiliary disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Anaphylactoid reaction
Immune system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Post procedural infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Abdominal sepsis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Arthritis viral
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Genital infection bacterial
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Otitis media chronic
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Peritonitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Systemic infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Viral infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Wound infection staphylococcal
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pneumonia staphylococcal
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Dementia
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Facial Paralysis
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Iiird nerve paralysis
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0005 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Gangrene
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Cerebrovascular disorder
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Kidney infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Urosepsis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Intracranial aneurysm
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Sciatica
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Seizure
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Infectious colitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort E and is not related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Carotid artery occlusion
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0012 affected64 at risk
EG0022 affected65 at risk
EG003
Renal artery stenosis
Renal and urinary disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Peripheral artery restenosis
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Spinal column injury
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
International normalised ratio increased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Liver function test increased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Skin squamous cell carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort A and is not related.
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Large cell lung cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Non-hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Vulval cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Central nervous system leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort D and is not related.
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Acute lymphocytic leukaemia recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Skin swelling
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Mucocutaneous haemorrhage
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG00010 affected203 at risk
EG0014 affected64 at risk
EG0021 affected65 at risk
EG003
Peripheral artery stenosis
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0004 affected203 at risk
EG0013 affected64 at risk
EG0020 affected65 at risk
EG003
Peripheral artery occlusion
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0004 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0011 affected64 at risk
EG0021 affected65 at risk
EG003
Dry gangrene
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Aortic arteriosclerosis
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Temporal arteritis
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Varicose vein
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Vasculitis
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Coeliac artery occlusion
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Embolism arterial
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Intermittent claudication
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Neuroendocrine carcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Cataract
Eye disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Cystoid macular oedema
Eye disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Retinal artery occlusion
Eye disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Retinal vein thrombosis
Eye disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Ulcerative keratitis
Eye disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Vision blurred
Eye disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Macular fibrosis
Eye disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Immobile
Social circumstances
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected203 at risk
EG0011 affected64 at risk
EG0024 affected65 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0003 affected203 at risk
EG0014 affected64 at risk
EG0022 affected65 at risk
EG003
Thyroid mass
Endocrine disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0005 affected203 at risk
EG0011 affected64 at risk
EG0022 affected65 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Blood potassium increased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
JC polyomavirus test positive
Investigations
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0021 affected65 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0010 affected64 at risk
EG0020 affected65 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected203 at risk
EG0011 affected64 at risk
EG0020 affected65 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA version 19.0
Systematic Assessment
One treatment-emergent death occurred during treatment with ponatinib in Cohort A and is not related.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Units
Counts
Participants
OG00065
OG00118
Title
Denominators
Categories
Title
Measurements
OG00056.9(44.0 to 69.2)
OG00155.6(30.8 to 78.5)
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Units
Counts
Participants
OG00048
OG00146
Title
Denominators
Categories
Title
Measurements
OG00035.4(22.2 to 50.5)
OG00132.6(19.5 to 48.0)
Units
Counts
Participants
OG000203
OG00164
Title
Denominators
Categories
Title
Measurements
OG00094.6(90.5 to 97.3)
OG00192.2(82.7 to 97.4)
Units
Counts
Participants
OG000203
OG00164
Title
Denominators
Categories
Title
Measurements
OG00040.9(34.1 to 48.0)
OG00162.5(49.5 to 74.3)
Units
Counts
Participants
OG000203
OG00164
Title
Denominators
Categories
Title
Measurements
OG00035.0(28.4 to 42.0)
OG00157.8(44.8 to 70.1)
OG002
Cohort E: BP-CML/Ph+ ALL R-I
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG003
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Units
Counts
Participants
OG00065
OG00118
OG00248
OG00346
Title
Denominators
Categories
Title
Measurements
OG00033.8(22.6 to 46.6)
OG00155.6(30.8 to 78.5)
OG00227.1(15.3 to 41.8)
OG00334.8(21.4 to 50.2)
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG003
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Units
Counts
Participants
OG00065
OG00118
OG00248
OG00346
Title
Denominators
Categories
Title
Measurements
OG00024.6(14.8 to 36.9)
OG00138.9(17.3 to 64.3)
OG00220.8(10.5 to 35.0)
OG00315.2(6.3 to 28.9)
Cohort E: BP-CML/Ph+ ALL R-I
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG003
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Units
Counts
Participants
OG00065
OG00118
OG00248
OG00346
Title
Denominators
Categories
Title
Measurements
OG00018.5(9.9 to 30.0)
OG00133.3(13.3 to 59.0)
OG00218.8(8.9 to 32.6)
OG0034.3(0.5 to 14.8)
OG002
Cohort C: AP-CML R-I
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG003
Cohort D: AP-CML With T315I Mutation
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG004
Cohort E: BP-CML/Ph+ ALL R-I
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG005
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Units
Counts
Participants
OG000203
OG00164
OG00265
OG00318
OG00448
OG00546
Title
Denominators
Categories
Hematologic Response
ParticipantsOG000192
ParticipantsOG00159
ParticipantsOG00237
ParticipantsOG00310
ParticipantsOG00417
ParticipantsOG00515
Title
Measurements
OG00013.0(1 to 417)
OG00110.0(4 to 1008)
OG00221.0(12 to 112)
OG003
Cytogenetic Response
ParticipantsOG000103
ParticipantsOG00145
ParticipantsOG00222
ParticipantsOG00310
Molecular Response
ParticipantsOG00071
ParticipantsOG00137
ParticipantsOG00212
ParticipantsOG0036
OG002
Cohort C: AP-CML R-I
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG003
Cohort D: AP-CML With T315I Mutation
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG004
Cohort E: BP-CML/Ph+ ALL R-I
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG005
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Units
Counts
Participants
OG000203
OG00164
OG00265
OG00318
OG00448
OG00546
Title
Denominators
Categories
Hematologic Response
ParticipantsOG000192
ParticipantsOG00159
ParticipantsOG00237
ParticipantsOG00310
ParticipantsOG00417
ParticipantsOG00515
Title
Measurements
OG000NA(36 to 2172)Duration of response was not reached for Cohorts A and B due to fewer number of participants with events.
OG001NA(33 to 2171)Duration of response was not reached for Cohorts A and B due to fewer number of participants with events.
OG002360.0(35 to 2079)
OG003
Cytogenetic Response
ParticipantsOG000103
ParticipantsOG00145
ParticipantsOG00222
ParticipantsOG00310
Molecular Response
ParticipantsOG00071
ParticipantsOG00137
ParticipantsOG00212
ParticipantsOG0036
Cohort B: CP-CML With T315I Mutation
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG002
Cohort C: AP-CML R-I
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG003
Cohort D: AP-CML With T315I Mutation
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG004
Cohort E: BP-CML/Ph+ ALL R-I
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG005
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Units
Counts
Participants
OG000203
OG00164
OG00265
OG00318
OG00448
OG00546
Title
Denominators
Categories
Title
Measurements
OG000NA(1285.0 to NA)PFS was not reached for Cohorts A and B due to fewer number of participants with events.
OG0011809.0(1028.0 to NA)PFS was not reached for Cohorts A and B due to fewer number of participants with events.
OG002432.0(335.0 to 714.0)
OG003959.0(186.0 to 1847.0)
OG004111.0(55.0 to 169.0)
OG00583.0(55.0 to 150.0)
OG003
Cohort D: AP-CML With T315I Mutation
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG004
Cohort E: BP-CML/Ph+ ALL R-I
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG005
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Units
Counts
Participants
OG000203
OG00164
OG00265
OG00318
OG00448
OG00546
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median OS has not been reached for Cohort A and B due to fewer number of participants with events.
OG001NA(NA to NA)Median OS has not been reached for Cohort A and B due to fewer number of participants with events.
OG0021689.0(969.0 to NA)Upper limit of 95% confidence interval was not estimable due to fewer number of participants with events.
OG0031847.0(281.0 to 2143.0)
OG004209.0(119.0 to 379.0)
OG005200.0(150.0 to 279.0)
OG001
Cohort B: CP-CML With T315I Mutation
CP-CML participants who had T315I mutation of breakpoint cluster region-Abelson complex (BCR-ABL) were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG002
Cohort C: AP-CML R-I
AP-CML R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG003
Cohort D: AP-CML With T315I Mutation
AP-CML participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG004
Cohort E: BP-CML/Ph+ ALL R-I
BP-CML or Ph+ ALL R-I to dasatinib or nilotinib or Ph+ ALL R-I to dasatinib or nilotinib were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG005
Cohort F: BP-CML or Ph+ ALL With T315I Mutation
BP-CML or Ph+ ALL participants who had T315I mutation of BCR-ABL were administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
OG006
Unassigned to Cohorts A-F
Participants who were not assigned to any of the cohorts and have no T315I mutation at study entry and were not resistant or intolerant to dasatinib or nilotinib, administered ponatinib 45 mg, tablet, orally, once daily until disease progression or development of intolerance or if they met one or more of the protocol defined criteria for discontinuation (Up to approximately 48 months).
Units
Counts
Participants
OG000203
OG00164
OG00265
OG00318
OG00448
OG00546
OG0065
Title
Denominators
Categories
TEAE
Title
Measurements
OG000203
OG00164
OG00265
OG00318
OG00448
OG00546
OG0065
SAE
Title
Measurements
OG000132
OG00139
OG00244
OG003
1 affected
18 at risk
EG0044 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0041 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0042 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0041 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0043 affected48 at risk
EG0052 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0041 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
2 affected
18 at risk
EG0042 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0041 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0041 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0044 affected48 at risk
EG0055 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0042 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0042 affected48 at risk
EG0052 affected46 at risk
EG0061 affected5 at risk
0 affected
18 at risk
EG0041 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0041 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0041 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0041 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0042 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
2 affected
18 at risk
EG0042 affected48 at risk
EG0052 affected46 at risk
EG0061 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
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EG0050 affected46 at risk
EG0061 affected5 at risk
0 affected
18 at risk
EG0041 affected48 at risk
EG0051 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
4 affected
18 at risk
EG0044 affected48 at risk
EG0053 affected46 at risk
EG0060 affected5 at risk
2 affected
18 at risk
EG0042 affected48 at risk
EG0053 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0043 affected48 at risk
EG0051 affected46 at risk
EG0061 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0061 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG00410 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0043 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
2 affected
18 at risk
EG0043 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0043 affected48 at risk
EG0050 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0041 affected48 at risk
EG0051 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0052 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
4 affected
18 at risk
EG0041 affected48 at risk
EG0050 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0061 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0061 affected5 at risk
3 affected
18 at risk
EG0048 affected48 at risk
EG0056 affected46 at risk
EG0061 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
4 affected
18 at risk
EG00411 affected48 at risk
EG0053 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG0045 affected48 at risk
EG0053 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0044 affected48 at risk
EG0052 affected46 at risk
EG0060 affected5 at risk
3 affected
18 at risk
EG0048 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
2 affected
18 at risk
EG0048 affected48 at risk
EG0054 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
4 affected
18 at risk
EG0044 affected48 at risk
EG0053 affected46 at risk
EG0060 affected5 at risk
4 affected
18 at risk
EG00415 affected48 at risk
EG0059 affected46 at risk
EG0064 affected5 at risk
0 affected
18 at risk
EG0041 affected48 at risk
EG0051 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG0043 affected48 at risk
EG0054 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0051 affected46 at risk
EG0062 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG0041 affected48 at risk
EG0053 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG0042 affected48 at risk
EG0052 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0042 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
3 affected
18 at risk
EG0042 affected48 at risk
EG0053 affected46 at risk
EG0060 affected5 at risk
2 affected
18 at risk
EG00411 affected48 at risk
EG0058 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0042 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0043 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0043 affected48 at risk
EG0051 affected46 at risk
EG0062 affected5 at risk
3 affected
18 at risk
EG0042 affected48 at risk
EG0051 affected46 at risk
EG0061 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0052 affected46 at risk
EG0061 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0052 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0042 affected48 at risk
EG0052 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0061 affected5 at risk
0 affected
18 at risk
EG0041 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0061 affected5 at risk
0 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0061 affected5 at risk
8 affected
18 at risk
EG00413 affected48 at risk
EG0058 affected46 at risk
EG0062 affected5 at risk
0 affected
18 at risk
EG0043 affected48 at risk
EG0051 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
1 affected
18 at risk
EG0040 affected48 at risk
EG0050 affected46 at risk
EG0060 affected5 at risk
31
BG00526
BG0062
BG007238
46
BG00534
BG0065
BG007407
0
BG0050
BG0060
BG0070
8
BG0057
BG0062
BG00759
1
BG0051
BG0060
BG00725
39
BG00538
BG0063
BG007352
0
BG0050
BG0060
BG0078
0
BG0050
BG0060
BG0073
20
BG00519
BG0060
BG007147
12
BG00511
BG0060
BG00734
20.5
(14 to 176)
OG00428.0(14 to 168)
OG00524.0(11 to 57)
ParticipantsOG00413
ParticipantsOG00516
Title
Measurements
OG00085.0(56 to 343)
OG00184.0(49 to 333)
OG002113.5(26 to 280)
OG00383.0(25 to 295)
OG00428.0(28 to 168)
OG00556.0(27 to 112)
ParticipantsOG0049
ParticipantsOG0052
Title
Measurements
OG000173.0(55 to 1686)
OG001167.0(81 to 756)
OG002340.5(55 to 1364)
OG003335.5(107 to 925)
OG00456.0(54 to 113)
OG00563.0(59 to 67)
732.0
(42 to 1334)
OG004196.0(54 to 1811)
OG005108.0(54 to 1038)
ParticipantsOG00413
ParticipantsOG00516
Title
Measurements
OG000NA(1 to 1963)Duration of response was not reached for Cohorts A and B due to fewer number of participants with events.
OG001NA(1 to 1903)Duration of response was not reached for Cohorts A and B due to fewer number of participants with events.
OG002NA(1 to 1779)Duration of response was not reached due to fewer number of participants with events.
OG003728.0(28 to 1569)
OG004NA(1 to 1770)Duration of response was not reached due to fewer number of participants with events.
OG00563.0(1 to 673)
ParticipantsOG0049
ParticipantsOG0052
Title
Measurements
OG000NA(78 to 1891)Duration of response was not reached for Cohorts A and B due to fewer number of participants with events.
OG001NA(1 to 1899)Duration of response was not reached for Cohorts A and B due to fewer number of participants with events.
OG002560.0(1 to 1666)
OG003222.0(1 to 783)
OG004NA(1 to 1742)Duration of response was not reached due to fewer number of participants with events.