A Study of Ponatinib in Japanese Participants With Chroni... | NCT01667133 | Trialant
NCT01667133
Sponsor
Ariad Pharmaceuticals
Status
Completed
Last Update Posted
Jun 13, 2022Actual
Enrollment
35Actual
Phase
Phase 1Phase 2
Conditions
Chronic Myeloid Leukemia (CML)
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Interventions
ponatinib - Phase 1
ponatinib - Phase 2
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT01667133
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
AP24534-11-106
Secondary IDs
Not provided
Brief Title
A Study of Ponatinib in Japanese Participants With Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL)
Official Title
A Phase 1/2 Multi-center, Open-label Study of Ponatinib in Japanese Patients With Chronic Myeloid Leukemia (CML) Who Have Failed Dasatinib or Nilotinib or Ph+ Acute Lymphoblastic Leukemia (ALL) Who Have Failed Prior Tyrosine Kinase Inhibitors (TKIs)
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Mar 2022
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
Aug 31, 2012Actual
Primary Completion Date
Aug 2, 2018Actual
Completion Date
Aug 2, 2018Actual
First Submitted Date
Aug 13, 2012
First Submission Date that Met QC Criteria
Aug 15, 2012
First Posted Date
Aug 17, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 1, 2021
Results First Submitted that Met QC Criteria
Mar 9, 2022
Results First Posted Date
Jun 13, 2022Actual
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
Mar 9, 2022
Last Update Posted Date
Jun 13, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Ariad PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 assess the safety and efficacy of ponatinib in Japanese patients with chronic myeloid leukemia (CML) who have experienced failure of dasatinib or nilotinib or with Ph+ acute lymphoblastic leukemia (ALL) following failure of prior tyrosine kinase inhibitors (TKIs).
Detailed Description
This multi-center, phase 1/2, open-label study will consist of two phases. The first will be a dose escalation phase employing a modified 3+3 design with two dose cohorts (30mg and 45mg). After 6 patients complete the first cycle in a cohort, safety events will be evaluated before opening the next dose cohort. Patients will continue on treatment as long as it is tolerated and disease progression has not occurred. Phase 2 will occur at the recommended dose determined in phase 1 in an additional 25 patients. Another 3 patients will be dosed at 15mg for collection of pharmacokinetic data. These patients may also escalate to the recommended dose and be assessed for efficacy and safety as phase 2 patients.
Efficacy measures include molecular, cytogenetic, and hematologic response rates at various time points; time to response; duration of response; and survival follow-up. Safety measures include routine physical and laboratory evaluations, adverse event monitoring, and ECGs. Other measures include mutation testing and molecular genetic assessment. Accrual is expected to take approximately 12 months, and patients will be followed for survival for up to 60 months from the last dose of study drug; therefore, the estimated duration of the trial is 72 months.
Conditions Module
Conditions
Chronic Myeloid Leukemia (CML)
Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Keywords
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
35Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1 dose escalation
Experimental
Phase 1
Drug: ponatinib - Phase 1
Phase 2 expansion
Experimental
Phase 2
Drug: ponatinib - Phase 2
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ponatinib - Phase 1
Drug
30 mg dose of ponatinib taken orally once daily for at least the first 6 patients. If no dose-limiting toxicities are observed, the next patients will receive 45 mg dose of ponatinib taken orally once daily. Once the recommended dose is confirmed, all patients may receive the recommended dose, at the investigators' discretion.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) as a Measure of Safety Profile to Determine Recommended Dose of Ponatinib
DLT was evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 and was defined as any of the following events: 1. Grade greater than or equal to (>=) 3 non-hematologic, with the exception of medically controllable toxicities (example; nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting <=3 days, but excluding alopecia; 2. Missed doses: >25% of planned ponatinib doses over 28 days due to AEs in the first cycle; 3. Febrile neutropenia (the occurrence of an ANC <500/microliter concurrently with a temperature elevation of >101 degree Fahrenheit), when neutropenia is not related to underlying acute leukemia, as defined hematologic toxicity: Dose-limiting hematologic toxicity is the occurrence of a Grade 4 cytopenia >28 days, not related to underlying disease according to the investigator. Bone marrow examination must demonstrate <5% cellularity.
Cycle 1 (Cycle length= 28 days)
Phase 2, CP-CML Participants: Percentage of Participants With Major Cytogenetic Response (MCyR)
MCyR was defined as percentage of participants who achieved a complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR) after the initiation of study treatment. Cytogenic response was the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells. Participants entering the study already in PCyR had to achieve a CCyR in order to be considered a success for the confirmed MCyR rate.
Baseline up to 60 months
Phase 2, BP-CML and Ph+ALL: Percentage of Participants With Major Hematologic Response (MaHR)
MaHR was defined as percentage of participants with complete hematologic response (CHR) or no evidence of leukemia (NEL). MaHR response was confirmed by a peripheral blood complete blood count (CBC) and differential no earlier than 28 days after the response was observed. Response criteria for CHR was reported as white blood cells (WBC)<=institutional upper limit of normal (ULN), 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 reported as WBC<=institutional ULN, 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
CP-CML Participants: Percentage of Participants With CHR
Hematologic response was defined as CHR for CP-CML participants. Participants who entered the trial in CHR and continued to meet the criteria for CHR on study were analyzed as responders. Response criteria for CHR was reported as WBC <=institutional ULN, platelets <450,000 per cubic millimeter (/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).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patients must have CML in any phase (CP, AP, or BP of any phenotype) or Ph+ ALL, as follows:
All patients must have screening bone marrow (BM) cytogenetics with conventional banding performed within 42 days prior to beginning treatment.
Examination of at least 20 metaphases is required in patients in CP. If less than 20 metaphases are examined, the BM aspirate must be repeated.
Adequate BM aspirate with differential cell counts is required in patients with AP, BP, or Ph+ ALL. If an adequate aspirate is not obtained, the aspirate must be repeated.
Be previously treated with and resistant, or intolerant, as defined in the protocol, to either dasatinib or nilotinib for CML or at least one TKI for Ph+ ALL, regardless of whether dasatinib or nilotinib or the prior TKI were used to treat newly diagnosed or resistant patients.
Must be ≥ 18 years old.
Provide written informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Minimum life expectancy of 3 months or more.
Adequate renal function defined as serum creatinine < 1.5 × upper limit of normal (ULN) for institution.
Adequate hepatic function defined as:
Total bilirubin < 1.5 × ULN
Alanine aminotransferase (ALT [SGPT]) and aspartate aminotransferase (AST [SGOT]) < 2.5 × ULN for institution (< 5 × ULN if liver involvement with leukemia)
Prothrombin time < 1.5 × ULN
Normal pancreatic status defined as:
Lipase ≤ 1.5 × ULN for institution
Amylase ≤ 1.5 × ULN for institution
Normal QT interval corrected (Fridericia) (QTcF) interval on screening ECG evaluation, defined as QTcF of ≤ 450 ms in males or ≤ 470 ms in females.
For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment.
Female and male patients who are of childbearing potential must agree to use an effective form of contraception with their sexual partners throughout participation in this study.
Ability to comply with study procedures, in the Investigator's opinion.
Exclusion Criteria:
Patients are not eligible for participation in the study if they meet any of the following exclusion criteria:
Received TKI therapy within 7 days prior to receiving the first dose of ponatinib, or have not recovered (> grade 1 by National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 [NCI CTCAE v.4.0]) from adverse events (AEs) (except alopecia) due to agents previously administered.
Received other therapies as follows:
For CP and AP patients, received interferon, cytarabine, or immunotherapy within 14 days, or any other cytotoxic chemotherapy, radiotherapy, or investigational therapy within 28 days prior to receiving the first dose of ponatinib.
For BP patients, received chemotherapy within 7 days prior to the first dose of ponatinib. Otherwise, 2a applies.
For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of ponatinib and other chemotherapy within 7 days prior to the first dose of ponatinib. Otherwise, 2a applies.
All patients are excluded if they have not recovered (> grade 1 by NCI CTCAE v.4.0) from AEs (except alopecia) due to agents previously administered.
Underwent autologous or allogeneic stem cell transplant < 60 days prior to receiving the first dose of ponatinib; any evidence of ongoing graft versus-host disease (GVHD) or GVHD requiring immunosuppressive therapy.
Take 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.
Have previously been treated with ponatinib.
Patients with CP-CML are excluded if they are in CCyR.
Patients with CP-CML are excluded if a baseline BM aspirate adequate for conventional cytogenetic analysis with 20 metaphases examined is not available.
Patients with AP-CML, BP-CML, or Ph+ ALL are excluded if they are in MaHR.
Patients with AP-CML, BP-CML, or Ph+ ALL are excluded if a baseline BM aspirate adequate for cell count and differential report is not available. Patients with a fibrotic marrow or dry tap that does not yield adequate cell counts for diagnosis are not evaluable for classification, and endpoints are not eligible.
Have active central nervous system (CNS) disease as evidenced by cytology or pathology. In the absence of clinical CNS disease, lumbar puncture is not required. History itself of CNS involvement is not exclusionary if CNS has been cleared with a documented negative lumbar puncture.
Have significant or active cardiovascular disease, specifically including, but not restricted to:
Myocardial infarction within 3 months prior to first dose of ponatinib
History of clinically significant atrial arrhythmia or any ventricular arrhythmia
Unstable angina within 3 months prior to first dose of ponatinib
Congestive heart failure within 3 months prior to first dose of ponatinib
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 orally administered ponatinib.
Have been diagnosed with another primary malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ, or controlled prostate cancer, which are allowed within 3 years).
Are pregnant or lactating. Women of childbearing potential must agree to an effective contraception from the time of signing the informed consent through the Follow-up Visit, approximately 30 days after last dose of ponatinib.
Underwent major surgery (with the exception of minor surgical procedures, such as catheter placement or BM biopsy) within 14 days prior to first dose of ponatinib.
Have ongoing or active infection (including known history of human immunodeficiency virus [HIV], hepatitis B virus [HBV], or hepatitis C virus [HCV]). Testing for these viruses is not required in the absence of history.
Suffer from any condition or illness that, in the opinion of the Investigator or the Medical Monitor, would compromise patients safety or interfere with the evaluation of the safety of the study drug.
Hanley MJ, Diderichsen PM, Narasimhan N, Srivastava S, Gupta N, Venkatakrishnan K. Population Pharmacokinetics of Ponatinib in Healthy Adult Volunteers and Patients With Hematologic Malignancies and Model-Informed Dose Selection for Pediatric Development. J Clin Pharmacol. 2022 Apr;62(4):555-567. doi: 10.1002/jcph.1990. Epub 2021 Dec 16.
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 with CP-CML, AP-CML, or BP-CML, or with Ph+ALL were enrolled in Phase 1 (dose-escalation) to receive 30 or 45 mg of ponatinib and recommended phase 2 dose in Phase 2 (expansion). As there was no participant enrolled in Phase 1: BP-CML Ponatinib 30 milligram (mg) arm, therefore the arm is not reported in the result summary. Participants in Phase 1 with CP-CML or AP-CML, BP-CML or Ph+ ALL and who had T315I mutation and other mutations were analyzed as subgroups in the study.
Recruitment Details
Participants took part in the study at 9 investigative sites in Japan from 31 August 2012 to 02 August 2018.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Ponatinib 30 mg: Phase 1 CP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with chronic phase (CP)-chronic myeloid leukemia (CML) resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
FG001
Periods
Title
Milestones
Reasons Not Completed
Phase 1: Dose-escalation
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
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
Prot
Yes
No
No
Study Protocol
Nov 21, 2013
Mar 1, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
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
Parallel 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
Phase 1 dose escalation
AP24534
ponatinib - Phase 2
Drug
Recommended dose of ponatinib as determined in the dose escalation phase. In addition, 3 patients will receive 15 mg dose once daily for 8 days for PK testing. These PK patients may be allowed to receive the recommended dose after PK testing is complete, at the investigators' discretion.
Phase 2 expansion
AP24534
Baseline up to 60 months
Baseline up to 60 months
CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Confirmed MCyR
Confirmed MCyR was defined as 2 assessments of CCyR or PCyR at least 28 days apart. Participants entering the trial in PCyR must achieve two consecutive assessments of CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. Participants entering the trial in less than PCyR must achieve two consecutive assessments of PCyR or CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells.
Baseline up to 60 months
CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Major Molecular Response (MMR)
MMR was 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). Participants were non-responders in any of the following situations: BCR-ABL or ABL levels not detectable at baseline, no valid baseline or post-baseline assessment, and baseline assessment for e1a2 variant only.
Baseline up to 60 months
CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Median Time to Response (TTR)
Time to response was defined as the interval from the first dose of study treatment until the criteria for response were first met, censored at the last assessment of response. Median time to response was estimated by Kaplan-Meier method.
From the first dose of study treatment until the criteria for response were first met (up to 60 months)
CP-CML and Advanced Phase Participants: Median Duration of Response (DOR)
DOR: interval between first assessment at which criteria for response was met, until criteria for progression was met, censored at last date at which criteria for response was met. DOR was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to >20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in complete blood cells (CBCs) at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; and BP/Ph+ALL was: death/increasing blasts in peripheral blood or BM over a 4-week period. As planned, DOR is reported for all participants by entry mutation (T315I and Other).
From the first assessment at which criteria for response was met until the criteria for progression was first met (up to 60 months)
CP-CML and Advanced Phase Participants: Median Progression-free Survival (PFS)
PFS: interval from the first dose of study treatment until the criteria for progression or death were met, censored at the last response assessment. PFS was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to >20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in CBCs at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; BP/Ph+ALL was: death or increasing blasts in peripheral blood or BM over a 4-week period. As planned, PFS is reported for all participants by entry mutation (T315I and Other).
From the first assessment at which criteria for response was met until the criteria for progression or death was met (up to 60 months)
CP-CML and Advanced Phase Participants: Overall Survival (OS)
OS was 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. Overall survival was estimated using the Kaplan-Meier method. As planned, OS is reported for all participants by entry mutation (T315I and Other).
From the first dose of study treatment until death (up to 60 months)
Cmax: Maximum Observed Plasma Concentration for Ponatinib
Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)
Tmax: Time to Reach the Cmax for Ponatinib
Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)
AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Ponatinib
Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)
T1/2: Terminal Phase Elimination Half-life for Ponatinib
Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)
Akita
Akita
010-8543
Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima
Hiroshima
730-8619
Japan
Kyushu University Hospital
Hukuoka-shi
Hukuoka
Japan
Kinki University Hospital, Faculty of Medicine
Osakasayama-shi
Osaka
589-8511
Japan
The Cancer Institute Hospital Japanese Foundation for Cancer Research
Koto
Tokyo
Japan
The University of Tokyo, The Institute of Medical Science
Minato-ku
Tokyo
Japan
Keio University Hospital
Shinjuku-ku
Tokyo
Japan
Osaka City University Hospital
Shinjuku-ku
Tokyo
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo
Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo
Japan
Derived
Tojo A, Kyo T, Yamamoto K, Nakamae H, Takahashi N, Kobayashi Y, Tauchi T, Okamoto S, Miyamura K, Hatake K, Iwasaki H, Matsumura I, Usui N, Naoe T, Tugnait M, Narasimhan NI, Lustgarten S, Farin H, Haluska F, Ohyashiki K. Ponatinib in Japanese patients with Philadelphia chromosome-positive leukemia, a phase 1/2 study. Int J Hematol. 2017 Sep;106(3):385-397. doi: 10.1007/s12185-017-2238-9. Epub 2017 Apr 25.
Ponatinib 30 mg: Phase 1 AP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with accelerated phase (AP)- CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
FG002
Ponatinib 30 mg: Phase 1 Ph+ ALL
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Philadelphia chromosome plus acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to prior tyrosine kinase inhibitor (TKIs) in Dose-escalation Phase 1.
FG003
Ponatinib 45 mg: Phase 1 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
FG004
Ponatinib 45 mg: Phase 1 AP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
FG005
Ponatinib 45 mg: Phase 1 BP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
FG006
Ponatinib 45 mg: Phase 1 Ph+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
FG007
Ponatinib 15 mg: Phase 2 CP- CML
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
FG008
Ponatinib 15 mg: Phase 2 Ph+ ALL
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).
FG009
Ponatinib 45 mg: Phase 2 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
FG010
Ponatinib 45 mg: Phase 2 BP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
FG011
Ponatinib 45 mg: Phase 2 PH+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
FG0001 subjects
FG0011 subjects
FG0024 subjects
FG0033 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0024 subjects
FG0031 subjects
FG0041 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Progressive Disease
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Phase 2: Dose-expansion
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0081 subjects
FG00911 subjects
FG0103 subjects
FG0116 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Treated population included all participants who had received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Ponatinib 30 mg: Phase 1 CP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
BG001
Ponatinib 30 mg: Phase 1 AP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
BG002
Ponatinib 30 mg: Phase 1 Ph+ ALL
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
BG003
Ponatinib 45 mg: Phase 1 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
BG004
Ponatinib 45 mg: Phase 1 AP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
BG005
Ponatinib 45 mg: Phase 1 BP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
BG006
Ponatinib 45 mg: Phase 1 Ph+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
BG007
Ponatinib 15 mg: Phase 2 CP-CML
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
BG008
Ponatinib 15 mg: Phase 2 Ph+ ALL
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).
BG009
Ponatinib 45 mg: Phase 2 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
BG010
Ponatinib 45 mg: Phase 2 BP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
BG011
Ponatinib 45 mg: Phase 2 PH+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0024
BG0033
BG0041
BG0051
BG0061
BG0072
BG0081
BG00911
BG0103
BG0116
BG01235
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00061.0
BG00162.0
BG00256.5± 11.73
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Asian
Title
Measurements
BG0001
BG0011
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Japan
Title
Measurements
BG0001
BG0011
BG002
Weight
Mean
Standard Deviation
kilogram (kg)
Title
Denominators
Categories
Title
Measurements
BG00067.0
BG00157.0
BG002
Height
Mean
Standard Deviation
centimeter (cm)
Title
Denominators
Categories
Title
Measurements
BG000163.6
BG001155.9
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
ECOG performance status used by doctors/researchers to assess how participant's disease is progressing, assess how disease affects daily living activities of participant and determine appropriate treatment/prognosis on 5-point scale. 0=Actively able to do activities; 1=Restricted in physical activity, able to do light/sedentary work; 2=Ambulatory (>50% of waking hours), capable of self-care, unable to do any work activities; 3=Capable of limited self-care, confined to bed >50% of waking hours; 4=Completely disabled, cannot do any self-care, totally confined to bed; 5=dead.
Count of Participants
Participants
Title
Denominators
Categories
0 = Fully Active
Title
Measurements
BG0001
BG001
Participants with Initial Diagnosis of Leukemia
Count of Participants
Participants
Title
Denominators
Categories
CP-CML
Title
Measurements
BG0001
BG0011
BG002
Time Since Diagnosis to Date of First Dose
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00010.29(10.29 to 10.29)
BG00121.65(21.65 to 21.65)
BG002
Participants with Extramedullary Involvement
Participants with extramedullary disease sites were assessed. Extramedullary disease occurs when myeloma cells form tumors outside the bone marrow in the soft tissues or organs of the body.
Count of Participants
Participants
Title
Denominators
Categories
Hepatomegaly
Title
Measurements
BG0000
BG001
Participants with BCR-ABL Ratio
Breakpoint cluster region-Abelson complex (BCR-ABL1) is an abnormal gene found in CML and acute lymphoblastic leukemia (ALL). The chromosomal defect in the Philadelphia chromosome is a translocation, in which parts of two chromosomes, 9 and 22, swap places. The result is that a fusion gene is created by juxtapositioning the Abl1 gene on chromosome 9 to a part of the BCR gene on chromosome 22. Depending upon the breakpoints on the BCR gene, there are several forms of fusion proteins. BCR-ABL ratio is assessed in % international scale (IS).
Count of Participants
Participants
Title
Denominators
Categories
Greater than (>)0.1 - less than or equal to (<=)1%
Title
Measurements
BG0000
BG001
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
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs) as a Measure of Safety Profile to Determine Recommended Dose of Ponatinib
DLT was evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 and was defined as any of the following events: 1. Grade greater than or equal to (>=) 3 non-hematologic, with the exception of medically controllable toxicities (example; nausea, vomiting, fatigue, electrolyte disturbances, hypersensitivity reactions) lasting <=3 days, but excluding alopecia; 2. Missed doses: >25% of planned ponatinib doses over 28 days due to AEs in the first cycle; 3. Febrile neutropenia (the occurrence of an ANC <500/microliter concurrently with a temperature elevation of >101 degree Fahrenheit), when neutropenia is not related to underlying acute leukemia, as defined hematologic toxicity: Dose-limiting hematologic toxicity is the occurrence of a Grade 4 cytopenia >28 days, not related to underlying disease according to the investigator. Bone marrow examination must demonstrate <5% cellularity.
DLT evaluable population (Phase 1 only) included all participants who had completed at least 75% of their planned doses during Cycle 1, unless missed doses were due to adverse events (AEs).
Posted
Count of Participants
Participants
Cycle 1 (Cycle length= 28 days)
ID
Title
Description
OG000
Ponatinib 30 mg: Phase 1 CP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG001
Ponatinib 30 mg: Phase 1 AP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG002
Ponatinib 30 mg: Phase 1 Ph+ ALL
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
OG003
Ponatinib 45 mg: Phase 1 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG004
Ponatinib 45 mg: Phase 1 AP CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG005
Ponatinib 45 mg: Phase 1 BP-CML
Units
Counts
Participants
OG0001
OG0011
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG003
Primary
Phase 2, CP-CML Participants: Percentage of Participants With Major Cytogenetic Response (MCyR)
MCyR was defined as percentage of participants who achieved a complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR) after the initiation of study treatment. Cytogenic response was the percentage of Philadelphia chromosome positive (Ph+) metaphases in bone marrow. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells. Participants entering the study already in PCyR had to achieve a CCyR in order to be considered a success for the confirmed MCyR rate.
Treated population included all participants who had received at least 1 dose of study drug. This outcome measure was planned to be assessed only in CP-CML participants of Phase 2.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline up to 60 months
ID
Title
Description
OG000
Ponatinib 15 mg: Phase 2 CP-CML
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
OG001
Ponatinib 45 mg: Phase 2 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
Primary
Phase 2, BP-CML and Ph+ALL: Percentage of Participants With Major Hematologic Response (MaHR)
MaHR was defined as percentage of participants with complete hematologic response (CHR) or no evidence of leukemia (NEL). MaHR response was confirmed by a peripheral blood complete blood count (CBC) and differential no earlier than 28 days after the response was observed. Response criteria for CHR was reported as white blood cells (WBC)<=institutional upper limit of normal (ULN), 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 reported as WBC<=institutional ULN, 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 who had received at least 1 dose of study drug. This outcome measure was planned to be assessed only in BP-CML and Ph+ALL participants of Phase 2.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline up to 60 months
ID
Title
Description
OG000
Ponatinib 15 mg: Phase 2 Ph+ ALL
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).
Secondary
CP-CML Participants: Percentage of Participants With CHR
Hematologic response was defined as CHR for CP-CML participants. Participants who entered the trial in CHR and continued to meet the criteria for CHR on study were analyzed as responders. Response criteria for CHR was reported as WBC <=institutional ULN, platelets <450,000 per cubic millimeter (/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 who had received at least 1 dose of study drug. This outcome measure was planned to be assessed only in CP-CML Participants of Phase 1 and 2.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline up to 60 months
ID
Title
Description
OG000
Ponatinib 30 mg: Phase 1 CP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG001
Ponatinib 45 mg: Phase 1 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
Secondary
CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Confirmed MCyR
Confirmed MCyR was defined as 2 assessments of CCyR or PCyR at least 28 days apart. Participants entering the trial in PCyR must achieve two consecutive assessments of CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. Participants entering the trial in less than PCyR must achieve two consecutive assessments of PCyR or CCyR no fewer than 28 days apart in order to be considered as meeting the criteria for confirmed MCyR. CCyR: no Ph+ cells. PCyR: 1% to 35% Ph+ cells.
Treated population included all participants who had received at least 1 dose of study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline up to 60 months
ID
Title
Description
OG000
Ponatinib 30 mg: Phase 1 CP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG001
Ponatinib 30 mg: Phase 1 AP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
Secondary
CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Percentage of Participants With Major Molecular Response (MMR)
MMR was 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). Participants were non-responders in any of the following situations: BCR-ABL or ABL levels not detectable at baseline, no valid baseline or post-baseline assessment, and baseline assessment for e1a2 variant only.
Treated population included all participants who had received at least 1 dose of study drug.
Posted
Number
95% Confidence Interval
percentage of participants
Baseline up to 60 months
ID
Title
Description
OG000
Ponatinib 30 mg: Phase 1 CP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG001
Ponatinib 30 mg: Phase 1 AP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG002
Ponatinib 30 mg: Phase 1 Ph+ ALL
Secondary
CP-CML, AP-CML, BP-CML, and Ph+ALL Participants: Median Time to Response (TTR)
Time to response was defined as the interval from the first dose of study treatment until the criteria for response were first met, censored at the last assessment of response. Median time to response was estimated by Kaplan-Meier method.
Treated population included all participants who had received at least 1 dose of study drug.
Posted
Median
Full Range
days
From the first dose of study treatment until the criteria for response were first met (up to 60 months)
ID
Title
Description
OG000
Ponatinib 30 mg: Phase 1 CP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG001
Ponatinib 30 mg: Phase 1 AP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG002
Ponatinib 30 mg: Phase 1 Ph+ ALL
Secondary
CP-CML and Advanced Phase Participants: Median Duration of Response (DOR)
DOR: interval between first assessment at which criteria for response was met, until criteria for progression was met, censored at last date at which criteria for response was met. DOR was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to >20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in complete blood cells (CBCs) at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; and BP/Ph+ALL was: death/increasing blasts in peripheral blood or BM over a 4-week period. As planned, DOR is reported for all participants by entry mutation (T315I and Other).
Treated population by entry mutation. Here number analyzed "n" are the participants who were evaluable for this outcome measure for given categories.
Posted
Median
95% Confidence Interval
days
From the first assessment at which criteria for response was met until the criteria for progression was first met (up to 60 months)
ID
Title
Description
OG000
Ponatinib 30 mg: Phase 1 CP-CML Participants With T315I Mutations
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had (T)hreonine-315-(I)soleucine mutation (T315I) mutation of BCR-ABL in Dose-escalation Phase 1.
Secondary
CP-CML and Advanced Phase Participants: Median Progression-free Survival (PFS)
PFS: interval from the first dose of study treatment until the criteria for progression or death were met, censored at the last response assessment. PFS was estimated using the Kaplan-Meier method. Progression criteria for CP was: death, development of AP/BP, or loss of CHR (in absence of cytogenic response), or loss of MCyR, or increasing WBC in participant without CHR (doubling of WBCs to >20,000 on 2 occasions at least 4 weeks apart, after first week of therapy), as confirmed by development in CBCs at least 4 weeks apart; AP was: death, development of confirmed BP, loss of previous major/minor hematologic response over-2 week period, or no decrease from baseline levels in percentage blasts in peripheral blood/BM on all assessments over a 4-week period; BP/Ph+ALL was: death or increasing blasts in peripheral blood or BM over a 4-week period. As planned, PFS is reported for all participants by entry mutation (T315I and Other).
Treated population by entry mutation. Here overall number analyzed "N" are the participants who were evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
days
From the first assessment at which criteria for response was met until the criteria for progression or death was met (up to 60 months)
ID
Title
Description
OG000
Ponatinib 30 mg: Phase 1 CP-CML Participants With T315I Mutations
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
Secondary
CP-CML and Advanced Phase Participants: Overall Survival (OS)
OS was 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. Overall survival was estimated using the Kaplan-Meier method. As planned, OS is reported for all participants by entry mutation (T315I and Other).
Treated population by entry mutation. Here overall number analyzed "N" are the participants who were evaluable for this outcome measure.
Posted
Median
95% Confidence Interval
days
From the first dose of study treatment until death (up to 60 months)
ID
Title
Description
OG000
Ponatinib 30 mg: Phase 1 CP-CML Participants With T315I Mutations
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
OG001
Ponatinib 45 mg: Phase 1 CP-CML Participants With T315I Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
Secondary
Cmax: Maximum Observed Plasma Concentration for Ponatinib
Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/mL)
Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)
ID
Title
Description
OG000
Ponatinib 15 mg
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to recommended phase 2 dose (RP2D) in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
OG001
Ponatinib 30 mg
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
OG002
Ponatinib 45 mg
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
Secondary
Tmax: Time to Reach the Cmax for Ponatinib
Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.
Posted
Median
Full Range
hour
Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)
ID
Title
Description
OG000
Ponatinib 15 mg
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to RP2D in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
OG001
Ponatinib 30 mg
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
OG002
Ponatinib 45 mg
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
Secondary
AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Ponatinib
Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.
Posted
Mean
Standard Deviation
hour*nanogram per milliliter (h*ng/mL)
Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)
ID
Title
Description
OG000
Ponatinib 15 mg
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to RP2D in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
OG001
Ponatinib 30 mg
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
OG002
Ponatinib 45 mg
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
Secondary
T1/2: Terminal Phase Elimination Half-life for Ponatinib
Treated population include all participants who had received at least 1 dose of study drug and for whom PK samples were collected. As planned, PK samples were analyzed per dose level.
Posted
Median
Full Range
hours
Cycle 1 Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose (Cycle length= 28 days)
ID
Title
Description
OG000
Ponatinib 15 mg
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment Cycle 1 before 15 mg was dose-escalated to RP2D in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
OG001
Ponatinib 30 mg
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
OG002
Ponatinib 45 mg
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment Cycle 1 in participants with CP-CML, BP-CML, or AP-CML who were resistant or intolerant to dasatinib or nilotinib, or with Ph+ALL who were resistant or intolerant to prior TKIs.
Time Frame
Treatment-emergent adverse events (TEAEs) are AEs that started after the first dose of study drug up to 5 years and 11 months
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
Ponatinib 30 mg: Phase 1 CP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
0
1
1
1
1
1
EG001
Ponatinib 30 mg: Phase 1 AP-CML
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
0
1
0
1
1
1
EG002
Ponatinib 30 mg: Phase 1 Ph+ ALL
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
4
4
2
4
3
4
EG003
Ponatinib 45 mg: Phase 1 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
0
3
2
3
3
3
EG004
Ponatinib 45 mg: Phase 1 AP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
1
1
1
1
1
1
EG005
Ponatinib 45 mg: Phase 1 BP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
0
1
0
1
1
1
EG006
Ponatinib 45 mg: Phase 1 Ph+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
1
1
0
1
1
1
EG007
Ponatinib 15 mg: Phase 2 CP-CML
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
0
2
1
2
2
2
EG008
Ponatinib 15 mg: Phase 2 Ph+ ALL
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).
1
1
1
1
1
1
EG009
Ponatinib 45 mg: Phase 2 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
1
11
6
11
11
11
EG010
Ponatinib 45 mg: Phase 2 BP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
3
3
2
3
3
3
EG011
Ponatinib 45 mg: Phase 2 PH+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
6
6
1
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial Infarction
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG0030 affected3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
Angina unstable
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pneumonia legionella
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Sepsis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Laryngeal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Diabetic nephropathy
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Brain stem infarction
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Genital haemorrhage
Reproductive system and breast disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cataract
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Retinal vein occlusion
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Mechanical ileus
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Platelet count decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG0031 affected3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0097 affected11 at risk
EG0100 affected3 at risk
EG0112 affected6 at risk
Lipase increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0022 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0022 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0022 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Weight decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Amylase increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Weight increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
White blood cell count decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Blood uric acid increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Blood creatine phosphokinase decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Blood phosphorus increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Blood urea increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Brain natriuretic peptide increased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Electrocardiogram t wave inversion
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Hyperkalaemia
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypertension
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypotension
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Protein C decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Urine output decreased
Investigations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Asteatosis
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dermatitis exfoliative generalised
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Nail discolouration
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Papule
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0022 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Malaise
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Fatigue
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Face oedema
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hyperthermia
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Chest pain
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Peripheral swelling
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0022 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Angular cheilitis
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Tooth loss
Gastrointestinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Platelet count decreased
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0022 affected4 at risk
EG003
Neutrophil count decreased
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
White blood cell count decreased
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Nephrogenic anaemia
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Gingivitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Skin infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Conjunctivitis bacterial
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Gastroenteritis norovirus
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Hordeolum
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Impetigo
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Ophthalmic herpes zoster
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Paronychia
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pyoderma
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Tinea infection
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Blood cholesterol increased
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypouricaemia
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Steroid diabetes
Metabolism and nutrition disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cerebral artery occlusion
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dementia alzheimers type
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hemiplegia
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Parkinsons disease
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Seizure
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypertensive nephropathy
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Urethral pain
Renal and urinary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Allergic transfusion reaction
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cystitis radiation
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Post procedural inflammation
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Tooth avulsion
Injury, poisoning and procedural complications
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cataract
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
CONJUNCTIVITIS allergic
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0021 affected4 at risk
EG003
Corneal disorder
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Dry eye
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Eye pain
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Glaucoma
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Macular degeneration
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Uveitis
Eye disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0011 affected1 at risk
EG0020 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0001 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cardiac aneurysm
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cardiac discomfort
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0022 affected4 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Blood bilirubin increased
Hepatobiliary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Menstrual disorder
Reproductive system and breast disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Pain
General disorders
MedDRA (22.0)
Systematic Assessment
EG0000 affected1 at risk
EG0010 affected1 at risk
EG0020 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG006
Ponatinib 45 mg: Phase 1 Ph+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
3
OG0041
OG0051
OG0061
1
OG0040
OG0050
OG0060
Units
Counts
Participants
OG0002
OG00111
Title
Denominators
Categories
Title
Measurements
OG00050(1.3 to 98.7)
OG00163.6(30.8 to 89.1)
OG001
Ponatinib 45 mg: Phase 2 BP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
OG002
Ponatinib 45 mg: Phase 2 PH+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
Units
Counts
Participants
OG0001
OG0013
OG0026
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 97.5)
OG00133.3(0.8 to 90.6)
OG00283.3(35.9 to 99.6)
OG002
Ponatinib 15 mg: Phase 2 CP-CML
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
OG003
Ponatinib 45 mg: Phase 2 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
Units
Counts
Participants
OG0001
OG0013
OG0022
OG00311
Title
Denominators
Categories
Title
Measurements
OG000100(2.5 to 100)
OG001100(29.2 to 100)
OG002100(15.8 to 100)
OG00390.9(58.7 to 99.8)
OG002
Ponatinib 30 mg: Phase 1 Ph+ ALL
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
OG003
Ponatinib 45 mg: Phase 1 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG004
Ponatinib 45 mg: Phase 1 AP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG005
Ponatinib 45 mg: Phase 1 BP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG006
Ponatinib 45 mg: Phase 1 Ph+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 in participant with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
OG007
Ponatinib 15 mg: Phase 2 CP-CML
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
OG008
Ponatinib 15 mg: Phase 2 Ph+ ALL
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).
OG009
Ponatinib 45 mg: Phase 2 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
OG010
Ponatinib 45 mg: Phase 2 BP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 6 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
OG011
Ponatinib 45 mg: Phase 2 PH+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0033
OG0041
OG0051
OG0061
OG0072
OG0081
OG00911
OG0103
OG0116
Title
Denominators
Categories
Title
Measurements
OG000100(2.5 to 100)
OG0010(0.0 to 97.5)
OG0020(0 to 60.2)
OG003100(29.2 to 100)
OG004100(2.5 to 100)
OG005100(2.5 to 100)
OG006100(2.5 to 100)
OG0070(0.0 to 84.2)
OG0080(0.0 to 97.5)
OG00963.6(30.8 to 89.1)
OG01033.3(0.8 to 90.6)
OG01116.7(0.4 to 64.1)
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
OG003
Ponatinib 45 mg: Phase 1 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG004
Ponatinib 45 mg: Phase 1 AP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG005
Ponatinib 45 mg: Phase 1 BP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG006
Ponatinib 45 mg: Phase 1 Ph+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 in participant with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
OG007
Ponatinib 15 mg: Phase 2 CP-CML
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
OG008
Ponatinib 15 mg: Phase 2 Ph+ ALL
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).
OG009
Ponatinib 45 mg: Phase 2 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
OG010
Ponatinib 45 mg: Phase 2 BP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
OG011
Ponatinib 45 mg: Phase 2 PH+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0033
OG0041
OG0051
OG0061
OG0072
OG0081
OG00911
OG0103
OG0116
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 97.5)
OG0010(0.0 to 97.5)
OG0020(0.0 to 60.2)
OG003100(29.2 to 100)
OG0040(0.0 to 97.5)
OG0050(0.0 to 97.5)
OG0060(0.0 to 97.5)
OG00750.0(1.3 to 98.7)
OG0089(0.0 to 97.5)
OG00927.3(6.0 to 61.0)
OG01033.3(0.8 to 90.6)
OG0110(0.0 to 45.9)
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
OG003
Ponatinib 45 mg: Phase 1 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG004
Ponatinib 45 mg: Phase 1 AP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG005
Ponatinib 45 mg: Phase 1 BP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Dose-escalation Phase 1.
OG006
Ponatinib 45 mg: Phase 1 Ph+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle 1 in participant with Ph+ ALL resistant or intolerant to prior TKIs in Dose-escalation Phase 1.
OG007
Ponatinib 15 mg: Phase 2 CP-CML
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
OG008
Ponatinib 15 mg: Phase 2 Ph+ ALL
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with Ph+ ALL resistant or intolerant to prior TKIs in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle 1 for up to unacceptable drug reaction or disease progression (up to 60 months).
OG009
Ponatinib 45 mg: Phase 2 CP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
OG010
Ponatinib 45 mg: Phase 2 BP-CML
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with BP-CML resistant or intolerant to dasatinib or nilotinib in Expansion Phase 2.
OG011
Ponatinib 45 mg: Phase 2 PH+ ALL
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with PH+ ALL resistant or intolerant to prior TKI in Expansion Phase 2.
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0033
OG0041
OG0051
OG0061
OG0072
OG0082
OG00911
OG0103
OG0116
Title
Denominators
Categories
Cytogenic response
Title
Measurements
OG00085.0(85 to 85)
OG001NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG002NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG00385(85 to 169)
OG004113(113 to 113)
OG00529(29 to 29)
OG00628(28 to 28)
OG00784(84 to 84)
OG008NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG009167(84 to 755)
OG01031(31 to 31)
OG01129(24 to 58)
Hematologic response
Title
Measurements
OG000NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG00122(22 to 22)
OG00214.5(14 to 15)
OG003
Molecular response
Title
Measurements
OG000NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG001NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG002NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG003
OG001
Ponatinib 45 mg: Phase 1 CP-CML Participants With T315I Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
OG002
Ponatinib 15 mg: Phase 2 CP-CML Participants With T315I Mutations
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
OG003
Ponatinib 45 mg: Phase 2 CP-CML Participants With T315I Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2.
OG004
Ponatinib 30 mg: Phase 1 CP-CML Participants With Other Mutations
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
OG005
Ponatinib 45 mg: Phase 1 CP-CML Participants With Other Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
OG006
Ponatinib 15 mg: Phase 2 CP-CML Participants With Other Mutations
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
OG007
Ponatinib 45 mg: Phase 2 CP-CML Participants With Other Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.
OG012
Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
OG013
Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
OG014
Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations
Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.
OG015
Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.
Units
Counts
Participants
OG0001
OG0010
OG0020
OG0031
OG0040
OG0053
OG0062
OG0079
OG0082
OG0092
OG0100
OG0114
OG0121
OG0131
OG0140
OG0152
Title
Denominators
Categories
Cytogenic response
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
ParticipantsOG0040
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0076
ParticipantsOG0080
ParticipantsOG0092
ParticipantsOG0100
ParticipantsOG0114
ParticipantsOG0120
ParticipantsOG0131
ParticipantsOG0140
ParticipantsOG0151
Title
Measurements
OG0001513.0(NA to NA)95% CI were not estimable as excessive participants were censored.
OG003NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG005NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG006
Hematologic response
ParticipantsOG0001
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Molecular response
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
OG001
Ponatinib 45 mg: Phase 1 CP-CML Participants With T315I Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
OG002
Ponatinib 15 mg: Phase 2 CP-CML Participants With T315I Mutations
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
OG003
Ponatinib 45 mg: Phase 2 CP-CML Participants With T315I Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2.
OG004
Ponatinib 30 mg: Phase 1 CP-CML Participants With Other Mutations
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
OG005
Ponatinib 45 mg: Phase 1 CP-CML Participants With Other Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
OG006
Ponatinib 15 mg: Phase 2 CP-CML Participants With Other Mutations
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
OG007
Ponatinib 45 mg: Phase 2 CP-CML Participants With Other Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.
OG012
Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
OG013
Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
OG014
Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations
Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.
OG015
Phase 2: Ponatinib 45 mg, Advanced Phase Participants With Other Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment Cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.
Units
Counts
Participants
OG0001
OG0010
OG0020
OG0032
OG0040
OG0053
OG0062
OG0079
OG0083
OG0092
OG0101
OG0115
OG0122
OG0131
OG0140
OG0154
Title
Denominators
Categories
Title
Measurements
OG0001597.0(NA to NA)95% CI were not estimable as excessive participants were censored.
OG003NA(85.0 to NA)Median and 95% CI (upper limit) were not estimable as excessive participants were censored.
OG005NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG006NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG007NA(113.0 to NA)Median and 95% CI (upper limit) were not estimable as excessive participants were censored.
OG00851.0(29.0 to NA)95% CI (upper limit) were not estimable as excessive participants were censored.
OG009320.0(113.0 to NA)95% CI (upper limit) were not estimable as excessive participants were censored.
OG01033.0(NA to NA)95% CI were not estimable as excessive participants were censored.
OG011100.0(10.0 to NA)95% CI (upper limit) were not estimable as excessive participants were censored.
OG01256.5(10.0 to NA)95% CI (upper limit) were not estimable as excessive participants were censored.
OG013281.0(NA to NA)95% CI were not estimable as excessive participants were censored.
OG015127.5(85.0 to NA)95% CI (upper limit) were not estimable as excessive participants were censored.
OG002
Ponatinib 15 mg: Phase 2 CP-CML Participants With T315I Mutations
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
OG003
Ponatinib 45 mg: Phase 2 CP-CML Participants With T315I Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had T315I mutation of BCR-ABL in Expansion Phase 2.
OG004
Ponatinib 30 mg: Phase 1 CP-CML Participants With Other Mutations
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
OG005
Ponatinib 45 mg: Phase 1 CP-CML Participants With Other Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
OG006
Ponatinib 15 mg: Phase 2 CP-CML Participants With Other Mutations
Ponatinib 15 mg, tablet, orally, once daily for 7-days in a 28-day treatment cycle in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2. Dose was increased to ponatinib 45 mg in the same participants at the discretion of Investigator and was administered as tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months).
OG007
Ponatinib 45 mg: Phase 2 CP-CML Participants With Other Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with CP-CML resistant or intolerant to dasatinib or nilotinib and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Dose-escalation Phase 1.
Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had T315I mutation of BCR-ABL in Expansion Phase 2.
OG012
Ponatinib 30 mg: Phase 1 Advanced Phase Participants With Other Mutations
Ponatinib 30 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
OG013
Ponatinib 45 mg: Phase 1 Advanced Phase Participants With Other Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Dose-escalation Phase 1.
OG014
Ponatinib 15 mg: Phase 2 Advanced Phase Participants With Other Mutations
Ponatinib 15 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.
OG015
Ponatinib 45 mg: Phase 2 Advanced Phase Participants With Other Mutations
Ponatinib 45 mg, tablet, orally, once daily in a 28-day treatment cycle for up to unacceptable drug reaction or disease progression (up to 60 months) in participants with AP-CML and BP-CML resistant or intolerant to dasatinib or nilotinib and Ph+ ALL participants and who had mutation other than T315I, no mutations, and no sequencing data in Expansion Phase 2.
Units
Counts
Participants
OG0001
OG0010
OG0020
OG0032
OG0040
OG0053
OG0062
OG0079
OG0083
OG0092
OG0101
OG0115
OG0122
OG0131
OG0140
OG0154
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG003NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG005NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG006NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG007NA(1305.0 to NA)Median and 95% CI (upper limit) were not estimable as excessive participants were censored.
OG008201.0(194.0 to NA)95% CI (upper limit) were not estimable as excessive participants were censored.
OG009NA(527.0 to NA)Median and 95% CI (upper limit) were not estimable as excessive participants were censored.
OG010109.0(NA to NA)95% CI were not estimable as excessive participants were censored.
OG011264.0(169.0 to NA)95% CI (upper limit) were not estimable as excessive participants were censored.
OG012131.0(10.0 to NA)95% CI (upper limit) were not estimable as excessive participants were censored.
OG013382.0(NA to NA)95% CI were not estimable as excessive participants were censored.
OG015550.5(281.0 to NA)95% CI (upper limit) were not estimable as excessive participants were censored.
Units
Counts
Participants
OG0003
OG0016
OG0026
Title
Denominators
Categories
Title
Measurements
OG00023.67± 7.136
OG00131.55± 9.072
OG00289.13± 24.63
Units
Counts
Participants
OG0003
OG0016
OG0026
Title
Denominators
Categories
Title
Measurements
OG0004.00(4.0 to 6.2)
OG0016.75(3.9 to 8.1)
OG0025.00(4.0 to 6.0)
Units
Counts
Participants
OG0003
OG0016
OG0026
Title
Denominators
Categories
Title
Measurements
OG000336.00± 129.55
OG001495.98± 154.09
OG0021385.5± 456.20
Units
Counts
Participants
OG0003
OG0016
OG0026
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Data could not be calculated for t1/2 due to lack of PK time points beyond 24 hours post-dose.
OG001NA(NA to NA)Data could not be calculated for t1/2 due to lack of PK time points beyond 24 hours post-dose.
OG002NA(NA to NA)Data could not be calculated for t1/2 due to lack of PK time points beyond 24 hours post-dose.
0 affected
3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0093 affected11 at risk
EG0101 affected3 at risk
EG0113 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0101 affected3 at risk
EG0113 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0072 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0112 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0072 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0112 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0051 affected1 at risk
EG0061 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0094 affected11 at risk
EG0102 affected3 at risk
EG0112 affected6 at risk
2 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0112 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0041 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
2 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
1 affected
3 at risk
EG0041 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0081 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0114 affected6 at risk
3 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0072 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0102 affected3 at risk
EG0111 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0094 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0112 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0072 affected2 at risk
EG0081 affected1 at risk
EG0096 affected11 at risk
EG0103 affected3 at risk
EG0115 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0093 affected11 at risk
EG0100 affected3 at risk
EG0113 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0092 affected11 at risk
EG0101 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
2 affected
3 at risk
EG0040 affected1 at risk
EG0051 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0101 affected3 at risk
EG0112 affected6 at risk
2 affected
3 at risk
EG0041 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0093 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
1 affected
3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0091 affected11 at risk
EG0101 affected3 at risk
EG0111 affected6 at risk
1 affected
3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0101 affected3 at risk
EG0111 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 events0 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 events0 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0051 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0101 affected3 at risk
EG0111 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
3 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0081 affected1 at risk
EG0093 affected11 at risk
EG0102 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0041 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0090 affected11 at risk
EG0102 affected3 at risk
EG0112 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0091 affected11 at risk
EG0102 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
2 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0111 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 events0 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0102 affected3 at risk
EG0112 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0092 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0081 affected1 at risk
EG0096 affected11 at risk
EG0101 affected3 at risk
EG0113 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0093 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0093 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0041 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0101 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
2 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
2 affected
3 at risk
EG0040 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0081 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0071 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0041 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0092 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0061 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0094 affected11 at risk
EG0101 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
2 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0111 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0051 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
2 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
2 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0091 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
1 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0100 affected3 at risk
EG0110 affected6 at risk
0 affected
3 at risk
EG0040 affected1 at risk
EG0050 affected1 at risk
EG0060 affected1 at risk
EG0070 affected2 at risk
EG0080 affected1 at risk
EG0090 affected11 at risk
EG0101 affected3 at risk
EG0111 affected6 at risk
NA
(NA to NA)
Median and 95% CI were not estimable as excessive participants were censored.
OG00456(56 to 56)
OG00515(15 to 15)
OG006NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG007NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG008NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG009NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG01017(17 to 17)
OG01115(10 to 44)
85
(85 to 421)
OG004NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG005NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG006NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG00784(84 to 84)
OG008NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG009253.0(84 to 842)
OG01058(58 to 58)
OG011NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
NA
(NA to NA)
Median and 95% CI were not estimable as excessive participants were censored.
OG007NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG009NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG01131.0(20.0 to NA)95% CI (upper limit) were not estimable as excessive participants were censored.
OG013169.0(NA to NA)95% CI were not estimable as excessive participants were censored.
OG015205.0(NA to NA)95% CI were not estimable as excessive participants were censored.
ParticipantsOG0040
ParticipantsOG0053
ParticipantsOG0062
ParticipantsOG0079
ParticipantsOG0082
ParticipantsOG0091
ParticipantsOG0100
ParticipantsOG0114
ParticipantsOG0121
ParticipantsOG0131
ParticipantsOG0140
ParticipantsOG0152
Title
Measurements
OG000NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG003NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG005NA(1226.0 to NA)Median and 95% CI (upper limit) were not estimable as excessive participants were censored.
OG006NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG007NA(85.0 to NA)Median and 95% CI (upper limit) were not estimable as excessive participants were censored.
OG00856.5(38.0 to NA)95% CI (upper limit) were not estimable as excessive participants were censored.
OG009NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG01150.5(33.0 to NA)95% CI (upper limit) were not estimable as excessive participants were censored.
OG012NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG013226.0(NA to NA)95% CI were not estimable as excessive participants were censored.
OG015113.5(110.0 to NA)95% CI (upper limit) were not estimable as excessive participants were censored.
ParticipantsOG0040
ParticipantsOG0053
ParticipantsOG0061
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0111
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
Title
Measurements
OG003NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG005NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG006NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG007NA(NA to NA)Median and 95% CI were not estimable as excessive participants were censored.
OG011168.0(NA to NA)95% CI were not estimable as excessive participants were censored.