A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT00777036
Collaborator
(none)
145
Enrollment
93
Locations
3
Arms
164.9
Anticipated Duration (Months)
1.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
145 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Dasatinib Therapy in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or With Ph+ Leukemias Resistant or Intolerant to Imatinib
Actual Study Start Date :
Mar 20, 2009
Actual Primary Completion Date :
Sep 1, 2016
Anticipated Study Completion Date :
Dec 16, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Cohort 1: Imatinib-resistant/intolerant CP-CML

Dasatinib 60 mg/m² tablet every day (QD) [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² powder for oral suspension (PFOS) QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

Drug: Dasatinib
Other Names:
  • Sprycel (BMS-354825)
  • Experimental: Cohort 2: Ph+ALL or AP- or BP-CML

    Dasatinib 80 mg/m² tablet QD [with a maximum dose of 140 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 96 mg/m² PFOS QD [with a maximum dose of 170 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

    Drug: Dasatinib
    Other Names:
  • Sprycel (BMS-354825)
  • Experimental: Cohort 3: Newly diagnosed, treatment naïve CP-CML

    Dasatinib 60 mg/m² tablet QD [with a maximum dose of 100 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² PFOS QD [with a maximum dose of 120 mg QD for subjects with high BSA] for minimum of 24 months, may continue as long as deriving clinical benefit

    Drug: Dasatinib
    Other Names:
  • Sprycel (BMS-354825)
  • Outcome Measures

    Primary Outcome Measures

    1. Major Cytogenetic Response (MCyR) Rate [From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)]

      Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response, expressed as percentage. The denominator of the MCyR response rate consists of all treated participants in Cohort 1, and the numerator is all participants in Cohort 1 achieving MCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.

    2. Complete Hematologic Response (CHR) Rate [From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)]

      Complete Hematologic Response (CHR) rate is defined as the proportion of all treated participants who achieve a confirmed CHR while on-study, expressed as percentage. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood, expressed as percentage. The denominator of the CHR response rate consists of all treated participants in Cohort 2, and the numerator is all participants in Cohort 2 achieving CHR. 95% confidence interval was calculated by Clopper-Pearson exact method.

    3. Complete Cytogenetic Response (CCyR) Rate [From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)]

      Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study, expressed as a percentage. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The denominator of the CCyR response rate consists of all treated participants in Cohort 3, and the numerator is all participants in Cohort 3 achieving CCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.

    Secondary Outcome Measures

    1. Major Cytogenetic Response (MCyR) Rate in Cohort 2 [From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)]

      Major Cytogenetic Response (MCyR) rate was defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants in each arm with MCyR is reported.

    2. Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3 [From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)]

      Complete Hematologic Response (CHR) rate defined as the proportion of all treated participants who achieve a confirmed CHR while on-study. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood. The percentage of treated participants in each arm with CHR is reported.

    3. Rate of Best Cytogenetic Response [From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)]

      The number of participants achieving their best on-study cytogenetic response was reported as a percentage of all treated participants in that arm. (Based on >=20 Metaphases)

    4. Time to Major Cytogenetic Response (MCyR) [From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)]

      Time to MCyR is defined as the time from first dose of dasatinib until the first day MCyR criteria are met, computed only for participants whose best response is MCyR. (Based on >=20 Metaphases)

    5. Duration of Major Cytogenetic Response (MCyR) [From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)]

      Duration of MCyR will be computed from the first day criteria are met for MCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on >=20 Metaphases)

    6. Time to Complete Cytogenetic Response (CCyR) [From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)]

      Time to CCyR is defined as the time from first dose of dasatinib until the first day CCyR criteria are met, computed only for participants whose best response is CCyR. (Based on >=20 Metaphases)

    7. Duration of Complete Cytogenetic Response (CCyR) [From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)]

      Duration of CCyR will be computed from the first day criteria are met for CCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on >=20 Metaphases)

    8. Progression-Free Survival (PFS) Rate at 2 Years [2 years]

      PFS is defined as time from the first dosing date until the time PD is first documented by the investigator or death. Participants who die without a reported date of progression will be considered to have progressed on the date of death. Participants who neither progress nor die will be censored on the date of their last cytogenetic or hematologic assessment. The percentages of progression-free participants at 2 years are based on Kaplan-Meier estimation. Disease Progression was defined as any of the following criteria: -For CP-CML, progression to AP-CML or BP-CML while at highest tolerated dose -Increasing WBC -Loss of CHR (defined as any of the following: WBC count rises to >20.0x10^9/L; Platelet count rises to >600x10^9/L; appearance of extramedullary disease; appearance of >5% myelocytes+metamyelocytes in blood; appearance of blasts/promyelocytes in peripheral blood) -Loss of MCyR or increase in Ph+ bone marrow cells by >=30% from nadir -Death from any case during treatment

    9. Time to Complete Hematologic Response (CHR) [From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)]

      Time to CHR is defined as the time from first dose of dasatinib until the first day CHR criteria are met, provided they are confirmed 4 weeks later, computed only for participants whose best response is CHR.

    10. Duration of Complete Hemotologic Response (CHR) [From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)]

      Duration of CHR will be computed from the first day all criteria are met for CHR, provided they are confirmed 4 weeks later, until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic assessment.

    11. Disease-Free Survival Rate at 2 Years [2 years]

      Disease free survival is defined as time from CCyR for participants with newly diagnosed chronic phase CML and for participants with chronic phase CML who are resistant or intolerant to imatinib (cohort 3 and cohort 1), and as time from CHR for participants with advanced phase CML and PH + ALL (cohort 2) until the time progression is first documented by the investigator or death from any cause. The percentages of disease-free participants at 2 years are based on Kaplan-Meier estimation. (CML: Chronic Myeloid Leukemia)

    12. Overall Survival (OS) Rate at 2 Years [2 years]

      OS is defined as time from the first dosing date until the time of death. All participants will be followed yearly for survival for up to 5 years after treatment discontinuation. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. The percentages of surviving participants at 2 years are based on Kaplan-Meier estimation.

    13. Major Molecular Response (MMR) Rate [From date of first treatment to date of MMR (assessed up to September 2016, approximately 90 months)]

      Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). MMR for participants with the p210 BCR-ABL transcript variant was defined as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale. In this study, ABL was used as the control-gene. For a participant with the p190 BCR-ABL transcript variant (occurring in Cohort 2 only), on-study assessments were compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline was considered an MMR.

    14. Complete Molecular Response (CMR) Rate [From date of first treatment to date of CMR (assessed up to September 2016, approximately 90 months)]

      Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.

    15. Major Cytogenetic Response (MCyR) Rate up to 2 Years [24 months]

      Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants with MCyR is reported by arm.

    16. Complete Cytogenetic Response (CCyR) Rate up to 2 Years [24 months]

      Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The percentage of treated participants with CCyR is reported by arm.

    17. Major Molecular Response (MMR) Rate up to 2 Years [24 months]

      Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time qPCR. MMR for participants with the p210 BCR-ABL transcript variant is defined according to the recommendations of Hughes et al. as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale proposed by the authors. The standardized baseline, as established in the IRIS trial, is taken to represent 100% on the international scale and a 3-log reduction in ratio (BCR-ABL transcripts/ABL or BCR) from the standardized baseline (MMR) is fixed at 0.1%. In this study, ABL or other housekeeping gene, will be used as the control-gene. For a participant with the p190 BCR-ABL transcript variant, on-study assessments will be compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline will be considered an MMR. The percentage of treated participants with MMR is reported by arm.

    18. Complete Molecular Response (CMR) Rate up to 2 Years [24 months]

      Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

    Inclusion Criteria:
    • CP-CML who prove resistant or intolerant to imatinib (Cohort 1)

    • Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (Cohort 2)

    • Newly diagnosed, treatment naive CP-CML (Cohort 3)

    • Lansky or Karnofsky scale >50

    • Life expectancy ≥12 weeks

    • Adequate hepatic and renal function

    • Written informed consent

    • Target Population for the PK substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation

    • Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasatinib tablets outside of this protocol may be invited to participate in this PK substudy

    • Target Population for the PK substudy subjects with CP-CML who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib PFOS dose of at least 72 mg/m2

    • Target Population for the PK substudy prior exposure to imatinib or other TKI therapy is permissible

    • Target Population for the PK substudy subjects must meet relevant inclusion criteria

    Exclusion Criteria:
    • Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation

    • Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease)

    • Isolated extramedullary disease

    • Prior therapy with Dasatinib

    • Target Population for the PK substudy subjects participating in the PK substudy must comply with the relevant exclusion criteria

    • Target Population for the PK substudy subjects are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy

    Other inclusion/exclusion criteria may apply

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Local InstitutionBirminghamAlabamaUnited States35233
    2Phoenix Children'S HospitalPhoenixArizonaUnited States85016
    3Jonathan Jaques Children'S Cancer CenterLong BeachCaliforniaUnited States90801-1428
    4Jonathan Jaques Children'S Cancer CenterLong BeachCaliforniaUnited States90806
    5Children'S Hospital Of Orange CountyOrangeCaliforniaUnited States92868
    6Children'S HospitalAuroraColoradoUnited States80045
    7Children's Healthcare Of Atlanta - EglestonAtlantaGeorgiaUnited States30322
    8Children's Hospital of ChicagoChicagoIllinoisUnited States60611
    9Local InstitutionChicagoIllinoisUnited States60611
    10Dana Faber Cancer InstituteBostonMassachusettsUnited States02215
    11Dana Farber Cancer Institute.BostonMassachusettsUnited States02215
    12Stephen D. Hassenfeld Children'S CenterNew YorkNew YorkUnited States10016
    13Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065
    14Memorial Sloan Kettering NassauNew YorkNew YorkUnited States10065
    15Oregon Health & Sci UnivPortlandOregonUnited States97239-3098
    16Oregon Health & Sci UnivPortlandOregonUnited States97239
    17Children'S Hospital Of PhiladelphiaPhiladelphiaPennsylvaniaUnited States19104-4318
    18Children'S Hospital Of PittsburghPittsburghPennsylvaniaUnited States15224
    19MD Anderson Cancer CenterHoustonTexasUnited States77030-4009
    20Texas Children'S Cancer CenterHoustonTexasUnited States77030
    21Seattle Children'SSeattleWashingtonUnited States98105
    22Local InstitutionBunos AiresBuenos AiresArgentina1425
    23Hospital Nacional Profesor Alejandro PosadasEl PalomarBuenos AiresArgentina1684
    24Local InstitutionCordobaArgentina5016
    25Local InstitutionRandwickNew South WalesAustralia2031
    26Local InstitutionWestmeadNew South WalesAustralia2145
    27Local InstitutionSth BrisbaneQueenslandAustralia4101
    28Local InstitutionNorth AdelaideSouth AustraliaAustralia5006
    29Local InstitutionParkvilleVictoriaAustralia3052
    30Local InstitutionCuritibaParanaBrazil80060-900
    31Local InstitutionPorto AlegreRio Grande Do SulBrazil90035-003
    32Local InstitutionCampinasBrazil13083-970
    33Local InstitutionSao PauloBrazil01401-000
    34Local InstitutionSao PauloBrazil04023-062
    35Alberta Children'S HospitalCalgaryAlbertaCanadaT3B 6A8
    36Stollery Children'S HospitalEdmontonAlbertaCanadaT6G 2B7
    37Bc Children'S HospitalVancouverBritish ColumbiaCanadaV6H 3V4
    38Iwk Health CentreHalifaxNova ScotiaCanadaB3K 6R8
    39Children'S Hospital Of Eastern OntarioOttawaOntarioCanadaK1H 8L1
    40The Hospital For Sick ChildrenTorontoOntarioCanadaM5G 1X8
    41Chu Ste-JustineMontrealQuebecCanadaH3T 1C5
    42Local InstitutionLyonFrance69008
    43Local InstitutionNantesFrance44093
    44Local InstitutionParis Cedex 12France75571
    45Local InstitutionParisFrance75012
    46Local InstitutionParisFrance75935
    47Local InstitutionPoitiersFrance86000
    48Local InstitutionFrankfurtGermany60590
    49Local InstitutionHannoverGermany30625
    50Local InstitutionNavrangpura, AhmedabadGujaratIndia380009
    51Local InstitutionBangaloreKarnatakaIndia560027
    52Local InstitutionMumbaiMaharashtraIndia400010
    53Local InstitutionPuneMaharashtraIndia411001
    54Local InstitutionMaduraiTamil NaduIndia625107
    55Local InstitutionVelloreTamilnaduIndia632004
    56Local InstitutionKolkattaIndia700 016
    57Local InstitutionMumbaiIndia400010
    58Local InstitutionTrivandrumIndia695011
    59Local InstitutionBolognaItaly40138
    60Local InstitutionMonza (mb)Italy20900
    61Local InstitutionRomaItaly00161
    62Local InstitutionRomaItaly00165
    63Local InstitutionTorinoItaly10126
    64Local InstitutionSeoulKorea, Republic of05505
    65Local InstitutionSeoulKorea, Republic of137-701
    66Local InstitutionDfDistrito FederalMexico06720
    67Local InstitutionMexico D.f.Distrito FederalMexico06726
    68Local InstitutionMexico, D. F.Distrito FederalMexico06726
    69Local InstitutionMexicoDistrito FederalMexico04530
    70Hospital Civil De Guadalajara - Nuevo Dr. Juan I. MenchacaGuadalajaraJaliscoMexico44340
    71Local InstitutionMonterrey, N.l.Nuevo LeonMexico64180
    72Local InstitutionMonterreyNuevo LeonMexico64460
    73Local InstitutionRotterdamNetherlands3015 GJ
    74Local InstitutionUtrechtNetherlands3584 CS
    75Local InstitutionBucharestRomania022322
    76Local InstitutionMoscowRussian Federation115478
    77Local InstitutionMoscowRussian Federation117198
    78Local InstitutionSaint-petersburgRussian Federation197022
    79Local InstitutionSingaporeSingapore119228
    80Local InstitutionBloemfonteinFREE StateSouth Africa9301
    81Local InstitutionPretoriaGautengSouth Africa0001
    82Local InstitutionCape TownWestern CAPESouth Africa7925
    83Local InstitutionTygerbergWestern CAPESouth Africa7505
    84Local InstitutionBarcelonaSpain08025
    85Local InstitutionBarcelonaSpain08035
    86Local InstitutionMadridSpain28009
    87Local InstitutionMadridSpain28046
    88Local InstitutionMalagaSpain29010
    89Local InstitutionValenciaSpain46009
    90Local InstitutionValenciaSpain
    91Local InstitutionGlasgowCentralUnited KingdomG3 8SJ
    92Local InstitutionSuttonSurreyUnited KingdomSM2 5PT
    93Local InstitutionBirminghamWest MidlandsUnited KingdomB4 6NH

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00777036
    Other Study ID Numbers:
    • CA180-226
    • 2008-002260-33
    First Posted:
    Oct 22, 2008
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsParticipants were enrolled at 80 sites (Argentina, Australia, Brazil, Canada, France, Germany, Great Britain, India, Italy, Korea, Mexico, Netherlands, Romania, Russia, Singapore, South Africa, Spain, and USA).
    Pre-assignment DetailA total of 145 participants were enrolled and 130 participants were treated in the study. Reasons for non-treatment include 2 withdrew consent, 1 died, 11 failed to meet study criteria, and 1 other non-specified.
    Arm/Group TitleCohort 1Cohort 2Cohort 3
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Period Title: On Treatment
    STARTED291784
    COMPLETED14161
    NOT COMPLETED151623
    Period Title: On Treatment
    STARTED141323
    COMPLETED9519
    NOT COMPLETED584

    Baseline Characteristics

    Arm/Group TitleCohort 1Cohort 2Cohort 3Total
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Total of all reporting groups
    Overall Participants291784130
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    12.60
    (4.774)
    12.10
    (3.680)
    11.95
    (4.418)
    12.12
    (4.388)
    Age, Customized (participants) [Number]
    < 2 years
    1
    3.4%
    0
    0%
    2
    2.4%
    3
    2.3%
    >= 2 to < 7 years
    3
    10.3%
    2
    11.8%
    10
    11.9%
    15
    11.5%
    >= 7 to < 12 years
    6
    20.7%
    6
    35.3%
    28
    33.3%
    40
    30.8%
    >= 12 to < 18 years
    17
    58.6%
    9
    52.9%
    44
    52.4%
    70
    53.8%
    >= 18 years
    2
    6.9%
    0
    0%
    0
    0%
    2
    1.5%
    Sex: Female, Male (Count of Participants)
    Female
    16
    55.2%
    9
    52.9%
    39
    46.4%
    64
    49.2%
    Male
    13
    44.8%
    8
    47.1%
    45
    53.6%
    66
    50.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    6.9%
    0
    0%
    5
    6%
    7
    5.4%
    Not Hispanic or Latino
    4
    13.8%
    0
    0%
    20
    23.8%
    24
    18.5%
    Unknown or Not Reported
    23
    79.3%
    17
    100%
    59
    70.2%
    99
    76.2%
    Race/Ethnicity, Customized (Count of Participants)
    White
    20
    69%
    13
    76.5%
    56
    66.7%
    89
    68.5%
    Black or African American
    2
    6.9%
    0
    0%
    4
    4.8%
    6
    4.6%
    Asian
    6
    20.7%
    3
    17.6%
    23
    27.4%
    32
    24.6%
    American Indian or Alaska Native
    0
    0%
    0
    0%
    1
    1.2%
    1
    0.8%
    Other
    1
    3.4%
    1
    5.9%
    0
    0%
    2
    1.5%

    Outcome Measures

    1. Primary Outcome
    TitleMajor Cytogenetic Response (MCyR) Rate
    DescriptionMajor Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response, expressed as percentage. The denominator of the MCyR response rate consists of all treated participants in Cohort 1, and the numerator is all participants in Cohort 1 achieving MCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.
    Time FrameFrom first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    Primary efficacy endpoint pre-specified only for participants treated in Cohort 1
    Arm/Group TitleCohort 1
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.
    Measure Participants29
    Number (95% Confidence Interval) [percentage of participants]
    89.7
    309.3%
    2. Primary Outcome
    TitleComplete Hematologic Response (CHR) Rate
    DescriptionComplete Hematologic Response (CHR) rate is defined as the proportion of all treated participants who achieve a confirmed CHR while on-study, expressed as percentage. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood, expressed as percentage. The denominator of the CHR response rate consists of all treated participants in Cohort 2, and the numerator is all participants in Cohort 2 achieving CHR. 95% confidence interval was calculated by Clopper-Pearson exact method.
    Time FrameFrom first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    Primary efficacy endpoint pre-specified only for participants treated in Cohort 2
    Arm/Group TitleCohort 2
    Arm/Group DescriptionChildren and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
    Measure Participants17
    Number (95% Confidence Interval) [percentage of participants]
    29.4
    101.4%
    3. Primary Outcome
    TitleComplete Cytogenetic Response (CCyR) Rate
    DescriptionComplete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study, expressed as a percentage. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The denominator of the CCyR response rate consists of all treated participants in Cohort 3, and the numerator is all participants in Cohort 3 achieving CCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.
    Time FrameFrom first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    Primary efficacy endpoint pre-specified only for participants treated in Cohort 3
    Arm/Group TitleCohort 3
    Arm/Group DescriptionChildren and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants84
    Number (95% Confidence Interval) [percentage of participants]
    94.0
    324.1%
    4. Secondary Outcome
    TitleMajor Cytogenetic Response (MCyR) Rate in Cohort 2
    DescriptionMajor Cytogenetic Response (MCyR) rate was defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants in each arm with MCyR is reported.
    Time FrameFrom first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    Secondary efficacy endpoint pre-specified only for participants treated in Cohort 2
    Arm/Group TitleCohort 2
    Arm/Group DescriptionChildren and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
    Measure Participants17
    Number (95% Confidence Interval) [percent of participants]
    52.9
    182.4%
    5. Secondary Outcome
    TitleComplete Hematologic Response (CHR) Rate in Cohorts 1 and 3
    DescriptionComplete Hematologic Response (CHR) rate defined as the proportion of all treated participants who achieve a confirmed CHR while on-study. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood. The percentage of treated participants in each arm with CHR is reported.
    Time FrameFrom first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    Secondary efficacy endpoint pre-specified only for participants treated in Cohort 1 and Cohort 3
    Arm/Group TitleCohort 1Cohort 3
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants2984
    Number (95% Confidence Interval) [percentage of participants]
    93.1
    321%
    96.4
    567.1%
    6. Secondary Outcome
    TitleRate of Best Cytogenetic Response
    DescriptionThe number of participants achieving their best on-study cytogenetic response was reported as a percentage of all treated participants in that arm. (Based on >=20 Metaphases)
    Time FrameFrom first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    All treated participants
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants2917845133
    Complete (0%)
    82.8
    285.5%
    29.4
    172.9%
    94.0
    111.9%
    96.1
    73.9%
    90.9
    NaN
    Partial (>0% - 35%)
    6.9
    23.8%
    23.5
    138.2%
    2.4
    2.9%
    2.0
    1.5%
    3.0
    NaN
    Minor (>35% - 65%)
    3.4
    11.7%
    0
    0%
    0
    0%
    0
    0%
    0
    NaN
    Minimal (>65% - 95%)
    3.4
    11.7%
    0
    0%
    1.2
    1.4%
    2.0
    1.5%
    0
    NaN
    No Response (>95% - 100%)
    0
    0%
    5.9
    34.7%
    0
    0%
    0
    0%
    0
    NaN
    Unable to Determine
    3.4
    11.7%
    41.2
    242.4%
    2.4
    2.9%
    0
    0%
    6.1
    NaN
    7. Secondary Outcome
    TitleTime to Major Cytogenetic Response (MCyR)
    DescriptionTime to MCyR is defined as the time from first dose of dasatinib until the first day MCyR criteria are met, computed only for participants whose best response is MCyR. (Based on >=20 Metaphases)
    Time FrameFrom first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    All treated participants with MCyR
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants269815031
    Median (95% Confidence Interval) [months]
    3.1
    1.6
    3.0
    3.3
    3.0
    8. Secondary Outcome
    TitleDuration of Major Cytogenetic Response (MCyR)
    DescriptionDuration of MCyR will be computed from the first day criteria are met for MCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on >=20 Metaphases)
    Time FrameFrom first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    All treated participants with MCyR
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants269815031
    Median (95% Confidence Interval) [months]
    NA
    11.2
    NA
    NA
    NA
    9. Secondary Outcome
    TitleTime to Complete Cytogenetic Response (CCyR)
    DescriptionTime to CCyR is defined as the time from first dose of dasatinib until the first day CCyR criteria are met, computed only for participants whose best response is CCyR. (Based on >=20 Metaphases)
    Time FrameFrom first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    All treated participants with CCyR
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants245794930
    Median (95% Confidence Interval) [months]
    3.9
    1.6
    5.6
    5.7
    5.6
    10. Secondary Outcome
    TitleDuration of Complete Cytogenetic Response (CCyR)
    DescriptionDuration of CCyR will be computed from the first day criteria are met for CCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on >=20 Metaphases)
    Time FrameFrom first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    All treated participants who achieved CCyR
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants245794930
    Median (95% Confidence Interval) [months]
    NA
    NA
    NA
    NA
    NA
    11. Secondary Outcome
    TitleProgression-Free Survival (PFS) Rate at 2 Years
    DescriptionPFS is defined as time from the first dosing date until the time PD is first documented by the investigator or death. Participants who die without a reported date of progression will be considered to have progressed on the date of death. Participants who neither progress nor die will be censored on the date of their last cytogenetic or hematologic assessment. The percentages of progression-free participants at 2 years are based on Kaplan-Meier estimation. Disease Progression was defined as any of the following criteria: -For CP-CML, progression to AP-CML or BP-CML while at highest tolerated dose -Increasing WBC -Loss of CHR (defined as any of the following: WBC count rises to >20.0x10^9/L; Platelet count rises to >600x10^9/L; appearance of extramedullary disease; appearance of >5% myelocytes+metamyelocytes in blood; appearance of blasts/promyelocytes in peripheral blood) -Loss of MCyR or increase in Ph+ bone marrow cells by >=30% from nadir -Death from any case during treatment
    Time Frame2 years

    Outcome Measure Data

    Analysis Population Description
    All treated participants
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants2917845133
    Number (95% Confidence Interval) [percentage]
    81.7
    20.5
    95.1
    94.0
    96.8
    12. Secondary Outcome
    TitleTime to Complete Hematologic Response (CHR)
    DescriptionTime to CHR is defined as the time from first dose of dasatinib until the first day CHR criteria are met, provided they are confirmed 4 weeks later, computed only for participants whose best response is CHR.
    Time FrameFrom first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    All treated participants with CHR
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants275815130
    Median (95% Confidence Interval) [months]
    0.7
    2.5
    1.2
    1.2
    1.0
    13. Secondary Outcome
    TitleDuration of Complete Hemotologic Response (CHR)
    DescriptionDuration of CHR will be computed from the first day all criteria are met for CHR, provided they are confirmed 4 weeks later, until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic assessment.
    Time FrameFrom first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    All treated participants with CCyR
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants275815130
    Median (95% Confidence Interval) [months]
    NA
    NA
    NA
    NA
    NA
    14. Secondary Outcome
    TitleDisease-Free Survival Rate at 2 Years
    DescriptionDisease free survival is defined as time from CCyR for participants with newly diagnosed chronic phase CML and for participants with chronic phase CML who are resistant or intolerant to imatinib (cohort 3 and cohort 1), and as time from CHR for participants with advanced phase CML and PH + ALL (cohort 2) until the time progression is first documented by the investigator or death from any cause. The percentages of disease-free participants at 2 years are based on Kaplan-Meier estimation. (CML: Chronic Myeloid Leukemia)
    Time Frame2 years

    Outcome Measure Data

    Analysis Population Description
    All randomized treated participants with response of CCyR or CHR
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants245794930
    Number (95% Confidence Interval) [percentage]
    86.9
    60.0
    98.7
    97.9
    100
    15. Secondary Outcome
    TitleOverall Survival (OS) Rate at 2 Years
    DescriptionOS is defined as time from the first dosing date until the time of death. All participants will be followed yearly for survival for up to 5 years after treatment discontinuation. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. The percentages of surviving participants at 2 years are based on Kaplan-Meier estimation.
    Time Frame2 years

    Outcome Measure Data

    Analysis Population Description
    All randomized and treated participants
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants2917845133
    Number (95% Confidence Interval) [percentage]
    96.4
    32.2
    100
    100
    100
    16. Secondary Outcome
    TitleMajor Molecular Response (MMR) Rate
    DescriptionMolecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). MMR for participants with the p210 BCR-ABL transcript variant was defined as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale. In this study, ABL was used as the control-gene. For a participant with the p190 BCR-ABL transcript variant (occurring in Cohort 2 only), on-study assessments were compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline was considered an MMR.
    Time FrameFrom date of first treatment to date of MMR (assessed up to September 2016, approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    All randomized treated participants
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants2917845133
    Number (95% Confidence Interval) [percentage of participants]
    62.1
    214.1%
    29.4
    172.9%
    79.8
    95%
    88.2
    67.8%
    66.7
    NaN
    17. Secondary Outcome
    TitleComplete Molecular Response (CMR) Rate
    DescriptionMolecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.
    Time FrameFrom date of first treatment to date of CMR (assessed up to September 2016, approximately 90 months)

    Outcome Measure Data

    Analysis Population Description
    All treated participants
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants2917845133
    Number (95% Confidence Interval) [percentage]
    24.1
    17.6
    29.8
    43.1
    9.1
    18. Secondary Outcome
    TitleMajor Cytogenetic Response (MCyR) Rate up to 2 Years
    DescriptionMajor Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants with MCyR is reported by arm.
    Time Frame24 months

    Outcome Measure Data

    Analysis Population Description
    All randomized treated participants
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants2917845133
    12 months
    89.7
    309.3%
    58.8
    345.9%
    96.4
    114.8%
    98.0
    75.4%
    93.9
    NaN
    24 months
    89.7
    309.3%
    58.8
    345.9%
    96.4
    114.8%
    98.0
    75.4%
    93.9
    NaN
    19. Secondary Outcome
    TitleComplete Cytogenetic Response (CCyR) Rate up to 2 Years
    DescriptionComplete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The percentage of treated participants with CCyR is reported by arm.
    Time Frame24 months

    Outcome Measure Data

    Analysis Population Description
    All randomized treated participants
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants2917845133
    12 months
    75.9
    261.7%
    41.2
    242.4%
    92.9
    110.6%
    96.1
    73.9%
    87.9
    NaN
    24 months
    82.8
    285.5%
    41.2
    242.4%
    94.0
    111.9%
    96.1
    73.9%
    90.9
    NaN
    20. Secondary Outcome
    TitleMajor Molecular Response (MMR) Rate up to 2 Years
    DescriptionMolecular response will be assessed using BCR-ABL transcript levels measurement by real-time qPCR. MMR for participants with the p210 BCR-ABL transcript variant is defined according to the recommendations of Hughes et al. as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale proposed by the authors. The standardized baseline, as established in the IRIS trial, is taken to represent 100% on the international scale and a 3-log reduction in ratio (BCR-ABL transcripts/ABL or BCR) from the standardized baseline (MMR) is fixed at 0.1%. In this study, ABL or other housekeeping gene, will be used as the control-gene. For a participant with the p190 BCR-ABL transcript variant, on-study assessments will be compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline will be considered an MMR. The percentage of treated participants with MMR is reported by arm.
    Time Frame24 months

    Outcome Measure Data

    Analysis Population Description
    All randomized treated participants
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants2917845133
    12 months
    41.4
    142.8%
    23.5
    138.2%
    52.4
    62.4%
    56.9
    43.8%
    45.5
    NaN
    24 months
    55.2
    190.3%
    29.4
    172.9%
    70.2
    83.6%
    74.5
    57.3%
    63.6
    NaN
    21. Secondary Outcome
    TitleComplete Molecular Response (CMR) Rate up to 2 Years
    DescriptionMolecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.
    Time Frame24 months

    Outcome Measure Data

    Analysis Population Description
    All randomized treated participants
    Arm/Group TitleCohort 1Cohort 2Cohort 3Cohort 3aCohort 3b
    Arm/Group DescriptionChildren and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL, AP-CML or BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD or powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.
    Measure Participants2917845133
    12 months
    6.9
    11.8
    8.3
    9.8
    6.1
    24 months
    17.2
    11.8
    21.4
    29.4
    9.1

    Adverse Events

    Time FrameFrom date of first dose of study therapy to date of last dose plus 30 days (assessed up to September 2016, approximately 90 months)
    Adverse Event Reporting Description
    Arm/Group TitleCohort 3aCohort 3bCohort 1Cohort 2: BP-CML OnlyCohort 2: Ph+ ALL Only
    Arm/Group DescriptionChildren and adolescents with CP-CML who were treatment-naive received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were treatment-naive received dasatinib powder for oral suspension (PFOS) at 72 mg/m2 QD on a continuous oral regimen.Children and adolescents with CP-CML who were resistant or intolerant to imatinib received dasatinib tablets at 60 mg/m2 QD on a continuous oral regimen.Children and adolescents with BP-CML who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.Children and adolescents with Ph+ ALL who were resistant or intolerant to, or relapsed after imatinib therapy received dasatinib tablets at a dose schedule of 80 mg/m2 QD on a continuous oral regimen.
    All Cause Mortality
    Cohort 3aCohort 3bCohort 1Cohort 2: BP-CML OnlyCohort 2: Ph+ ALL Only
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Cohort 3aCohort 3bCohort 1Cohort 2: BP-CML OnlyCohort 2: Ph+ ALL Only
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total19/51 (37.3%) 9/33 (27.3%) 13/29 (44.8%) 7/8 (87.5%) 6/9 (66.7%)
    Blood and lymphatic system disorders
    Anaemia3/51 (5.9%) 1/33 (3%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Febrile neutropenia2/51 (3.9%) 1/33 (3%) 0/29 (0%) 2/8 (25%) 3/9 (33.3%)
    Leukocytosis0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 1/9 (11.1%)
    Leukopenia0/51 (0%) 1/33 (3%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Lymphadenopathy1/51 (2%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Neutropenia0/51 (0%) 1/33 (3%) 2/29 (6.9%) 2/8 (25%) 0/9 (0%)
    Cardiac disorders
    Left ventricular dysfunction0/51 (0%) 0/33 (0%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Gastrointestinal disorders
    Abdominal pain2/51 (3.9%) 1/33 (3%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Anal ulcer0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Colitis1/51 (2%) 0/33 (0%) 1/29 (3.4%) 0/8 (0%) 1/9 (11.1%)
    Diarrhoea0/51 (0%) 3/33 (9.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Enteritis0/51 (0%) 1/33 (3%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Gastrointestinal haemorrhage0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Haematochezia1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Pancreatitis0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Rectal haemorrhage0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Stomatitis0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Vomiting0/51 (0%) 3/33 (9.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    General disorders
    Chills1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Disease progression0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Fatigue1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Oedema peripheral1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Pain0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Pyrexia2/51 (3.9%) 3/33 (9.1%) 2/29 (6.9%) 2/8 (25%) 0/9 (0%)
    Hepatobiliary disorders
    Hepatic function abnormal0/51 (0%) 0/33 (0%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Immune system disorders
    Drug hypersensitivity0/51 (0%) 1/33 (3%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Infections and infestations
    Bacterial sepsis0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Cellulitis0/51 (0%) 1/33 (3%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Device related infection0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Gastroenteritis1/51 (2%) 0/33 (0%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Gastrointestinal infection1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Infection1/51 (2%) 0/33 (0%) 2/29 (6.9%) 1/8 (12.5%) 0/9 (0%)
    Meningitis aseptic1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Myringitis1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Oral herpes0/51 (0%) 0/33 (0%) 0/29 (0%) 2/8 (25%) 0/9 (0%)
    Otitis externa1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Periorbital cellulitis1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Sepsis0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Upper aerodigestive tract infection1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Upper respiratory tract infection0/51 (0%) 1/33 (3%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Injury, poisoning and procedural complications
    Facial bones fracture1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Gun shot wound1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Hand fracture1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Overdose1/51 (2%) 1/33 (3%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Investigations
    Alanine aminotransferase increased0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Aspartate aminotransferase increased0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    White blood cell count decreased2/51 (3.9%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Metabolism and nutrition disorders
    Decreased appetite0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Dehydration2/51 (3.9%) 1/33 (3%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Musculoskeletal and connective tissue disorders
    Osteonecrosis1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Pain in extremity1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute lymphocytic leukaemia recurrent0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Blast cell proliferation0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Blast crisis in myelogenous leukaemia0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Chronic myeloid leukaemia0/51 (0%) 0/33 (0%) 1/29 (3.4%) 1/8 (12.5%) 0/9 (0%)
    Leukaemia0/51 (0%) 1/33 (3%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Leukaemia recurrent0/51 (0%) 2/33 (6.1%) 1/29 (3.4%) 1/8 (12.5%) 0/9 (0%)
    Malignant neoplasm progression0/51 (0%) 0/33 (0%) 0/29 (0%) 2/8 (25%) 2/9 (22.2%)
    Nervous system disorders
    Arachnoiditis0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Depressed level of consciousness0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Facial nerve disorder0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Headache1/51 (2%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Peripheral motor neuropathy0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Presyncope0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Seizure0/51 (0%) 0/33 (0%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Syncope1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Psychiatric disorders
    Confusional state0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Personality change1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Suicidal ideation1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Reproductive system and breast disorders
    Genital haemorrhage0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Uterine haemorrhage1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough0/51 (0%) 0/33 (0%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Pulmonary haemorrhage0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Respiratory failure0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Skin and subcutaneous tissue disorders
    Rash maculo-papular1/51 (2%) 1/33 (3%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Surgical and medical procedures
    Bone marrow transplant0/51 (0%) 0/33 (0%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Vascular disorders
    Jugular vein thrombosis0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Other (Not Including Serious) Adverse Events
    Cohort 3aCohort 3bCohort 1Cohort 2: BP-CML OnlyCohort 2: Ph+ ALL Only
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total50/51 (98%) 33/33 (100%) 27/29 (93.1%) 7/8 (87.5%) 9/9 (100%)
    Blood and lymphatic system disorders
    Anaemia10/51 (19.6%) 5/33 (15.2%) 2/29 (6.9%) 2/8 (25%) 2/9 (22.2%)
    Febrile neutropenia0/51 (0%) 1/33 (3%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Haemoglobinaemia0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Leukopenia3/51 (5.9%) 2/33 (6.1%) 2/29 (6.9%) 2/8 (25%) 0/9 (0%)
    Lymphadenopathy1/51 (2%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Lymphopenia1/51 (2%) 1/33 (3%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Neutropenia17/51 (33.3%) 8/33 (24.2%) 6/29 (20.7%) 4/8 (50%) 3/9 (33.3%)
    Pancytopenia0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Thrombocytopenia13/51 (25.5%) 7/33 (21.2%) 5/29 (17.2%) 4/8 (50%) 4/9 (44.4%)
    Ear and labyrinth disorders
    Ear pain7/51 (13.7%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Hypoacusis0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Eye disorders
    Dry eye1/51 (2%) 2/33 (6.1%) 1/29 (3.4%) 1/8 (12.5%) 0/9 (0%)
    Eye oedema1/51 (2%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Eye pain3/51 (5.9%) 1/33 (3%) 3/29 (10.3%) 0/8 (0%) 2/9 (22.2%)
    Periorbital oedema0/51 (0%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Vision blurred3/51 (5.9%) 1/33 (3%) 1/29 (3.4%) 1/8 (12.5%) 0/9 (0%)
    Gastrointestinal disorders
    Abdominal pain18/51 (35.3%) 7/33 (21.2%) 10/29 (34.5%) 1/8 (12.5%) 2/9 (22.2%)
    Abdominal pain upper12/51 (23.5%) 4/33 (12.1%) 8/29 (27.6%) 0/8 (0%) 0/9 (0%)
    Anal fissure0/51 (0%) 1/33 (3%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Anal ulcer0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Colitis3/51 (5.9%) 1/33 (3%) 1/29 (3.4%) 1/8 (12.5%) 1/9 (11.1%)
    Constipation9/51 (17.6%) 5/33 (15.2%) 4/29 (13.8%) 2/8 (25%) 0/9 (0%)
    Diarrhoea27/51 (52.9%) 12/33 (36.4%) 17/29 (58.6%) 3/8 (37.5%) 3/9 (33.3%)
    Dyspepsia0/51 (0%) 1/33 (3%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Flatulence0/51 (0%) 1/33 (3%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Gastritis6/51 (11.8%) 1/33 (3%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Gingival bleeding2/51 (3.9%) 0/33 (0%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Mouth ulceration0/51 (0%) 2/33 (6.1%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Nausea20/51 (39.2%) 10/33 (30.3%) 11/29 (37.9%) 3/8 (37.5%) 2/9 (22.2%)
    Oral pain2/51 (3.9%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Stomatitis2/51 (3.9%) 4/33 (12.1%) 0/29 (0%) 2/8 (25%) 1/9 (11.1%)
    Tongue ulceration0/51 (0%) 1/33 (3%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Toothache4/51 (7.8%) 1/33 (3%) 3/29 (10.3%) 0/8 (0%) 1/9 (11.1%)
    Vomiting22/51 (43.1%) 11/33 (33.3%) 15/29 (51.7%) 3/8 (37.5%) 3/9 (33.3%)
    General disorders
    Asthenia0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Chest pain2/51 (3.9%) 0/33 (0%) 3/29 (10.3%) 0/8 (0%) 0/9 (0%)
    Chills0/51 (0%) 3/33 (9.1%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Fatigue10/51 (19.6%) 7/33 (21.2%) 8/29 (27.6%) 1/8 (12.5%) 2/9 (22.2%)
    Influenza like illness0/51 (0%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Malaise1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Mass1/51 (2%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Mucosal inflammation0/51 (0%) 2/33 (6.1%) 1/29 (3.4%) 1/8 (12.5%) 0/9 (0%)
    Non-cardiac chest pain3/51 (5.9%) 3/33 (9.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Oedema peripheral2/51 (3.9%) 1/33 (3%) 3/29 (10.3%) 1/8 (12.5%) 0/9 (0%)
    Pain6/51 (11.8%) 5/33 (15.2%) 3/29 (10.3%) 1/8 (12.5%) 1/9 (11.1%)
    Peripheral swelling0/51 (0%) 0/33 (0%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Pyrexia23/51 (45.1%) 10/33 (30.3%) 14/29 (48.3%) 1/8 (12.5%) 5/9 (55.6%)
    Immune system disorders
    Drug hypersensitivity0/51 (0%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Hypersensitivity0/51 (0%) 0/33 (0%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Infections and infestations
    Abscess0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 1/9 (11.1%)
    Bronchitis0/51 (0%) 1/33 (3%) 3/29 (10.3%) 0/8 (0%) 0/9 (0%)
    Cellulitis3/51 (5.9%) 0/33 (0%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Conjunctivitis2/51 (3.9%) 2/33 (6.1%) 3/29 (10.3%) 0/8 (0%) 0/9 (0%)
    Ear infection5/51 (9.8%) 3/33 (9.1%) 1/29 (3.4%) 0/8 (0%) 1/9 (11.1%)
    Febrile infection0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Folliculitis2/51 (3.9%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Gastroenteritis7/51 (13.7%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 1/9 (11.1%)
    Gastroenteritis viral0/51 (0%) 1/33 (3%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Gingivitis1/51 (2%) 0/33 (0%) 1/29 (3.4%) 1/8 (12.5%) 0/9 (0%)
    Herpes virus infection0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Hordeolum0/51 (0%) 1/33 (3%) 2/29 (6.9%) 0/8 (0%) 1/9 (11.1%)
    Influenza6/51 (11.8%) 1/33 (3%) 3/29 (10.3%) 0/8 (0%) 0/9 (0%)
    Localised infection1/51 (2%) 2/33 (6.1%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Lower respiratory tract infection0/51 (0%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Nasopharyngitis10/51 (19.6%) 4/33 (12.1%) 7/29 (24.1%) 0/8 (0%) 0/9 (0%)
    Oral herpes4/51 (7.8%) 1/33 (3%) 0/29 (0%) 2/8 (25%) 0/9 (0%)
    Otitis media0/51 (0%) 0/33 (0%) 1/29 (3.4%) 1/8 (12.5%) 0/9 (0%)
    Pharyngitis6/51 (11.8%) 1/33 (3%) 2/29 (6.9%) 2/8 (25%) 2/9 (22.2%)
    Rhinitis7/51 (13.7%) 4/33 (12.1%) 3/29 (10.3%) 0/8 (0%) 1/9 (11.1%)
    Sinusitis3/51 (5.9%) 2/33 (6.1%) 4/29 (13.8%) 0/8 (0%) 1/9 (11.1%)
    Tonsillitis3/51 (5.9%) 1/33 (3%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Tooth infection3/51 (5.9%) 0/33 (0%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Upper respiratory tract infection16/51 (31.4%) 11/33 (33.3%) 9/29 (31%) 1/8 (12.5%) 1/9 (11.1%)
    Viral infection3/51 (5.9%) 0/33 (0%) 3/29 (10.3%) 0/8 (0%) 1/9 (11.1%)
    Injury, poisoning and procedural complications
    Arthropod bite0/51 (0%) 2/33 (6.1%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Contusion3/51 (5.9%) 4/33 (12.1%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Foot fracture0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Procedural pain2/51 (3.9%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Sunburn1/51 (2%) 1/33 (3%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Investigations
    Alanine aminotransferase increased3/51 (5.9%) 4/33 (12.1%) 4/29 (13.8%) 3/8 (37.5%) 1/9 (11.1%)
    Aspartate aminotransferase increased3/51 (5.9%) 3/33 (9.1%) 3/29 (10.3%) 2/8 (25%) 0/9 (0%)
    Blood creatinine increased0/51 (0%) 1/33 (3%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Blood lactate dehydrogenase increased2/51 (3.9%) 4/33 (12.1%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Blood phosphorus decreased0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Blood urea increased0/51 (0%) 1/33 (3%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Gamma-glutamyltransferase increased0/51 (0%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Haemoglobin decreased0/51 (0%) 5/33 (15.2%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Neutrophil count decreased1/51 (2%) 5/33 (15.2%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Platelet count decreased2/51 (3.9%) 11/33 (33.3%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Weight decreased3/51 (5.9%) 1/33 (3%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Weight increased3/51 (5.9%) 3/33 (9.1%) 2/29 (6.9%) 1/8 (12.5%) 0/9 (0%)
    Metabolism and nutrition disorders
    Decreased appetite4/51 (7.8%) 1/33 (3%) 2/29 (6.9%) 1/8 (12.5%) 0/9 (0%)
    Fluid retention0/51 (0%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Hypercalcaemia0/51 (0%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Hyperkalaemia0/51 (0%) 3/33 (9.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Hypermagnesaemia1/51 (2%) 1/33 (3%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Hypernatraemia0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Hyperphosphataemia0/51 (0%) 1/33 (3%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Hyperuricaemia0/51 (0%) 4/33 (12.1%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Hypoalbuminaemia1/51 (2%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Hypocalcaemia2/51 (3.9%) 3/33 (9.1%) 2/29 (6.9%) 1/8 (12.5%) 0/9 (0%)
    Hypokalaemia2/51 (3.9%) 1/33 (3%) 0/29 (0%) 2/8 (25%) 1/9 (11.1%)
    Hypomagnesaemia1/51 (2%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Hyponatraemia1/51 (2%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Hypophosphataemia0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia11/51 (21.6%) 6/33 (18.2%) 6/29 (20.7%) 1/8 (12.5%) 1/9 (11.1%)
    Back pain7/51 (13.7%) 6/33 (18.2%) 4/29 (13.8%) 1/8 (12.5%) 0/9 (0%)
    Bone pain5/51 (9.8%) 0/33 (0%) 1/29 (3.4%) 1/8 (12.5%) 3/9 (33.3%)
    Coccydynia0/51 (0%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Groin pain3/51 (5.9%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Muscle spasms0/51 (0%) 0/33 (0%) 1/29 (3.4%) 0/8 (0%) 1/9 (11.1%)
    Musculoskeletal chest pain1/51 (2%) 4/33 (12.1%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Musculoskeletal pain5/51 (9.8%) 7/33 (21.2%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Musculoskeletal stiffness1/51 (2%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Myalgia3/51 (5.9%) 6/33 (18.2%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Neck pain2/51 (3.9%) 2/33 (6.1%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Pain in extremity11/51 (21.6%) 14/33 (42.4%) 15/29 (51.7%) 2/8 (25%) 0/9 (0%)
    Pain in jaw0/51 (0%) 1/33 (3%) 3/29 (10.3%) 0/8 (0%) 0/9 (0%)
    Tendonitis0/51 (0%) 0/33 (0%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma3/51 (5.9%) 3/33 (9.1%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Nervous system disorders
    Arachnoiditis0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Brain oedema0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Dizziness12/51 (23.5%) 3/33 (9.1%) 2/29 (6.9%) 1/8 (12.5%) 0/9 (0%)
    Dysgeusia0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Facial paralysis0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Headache24/51 (47.1%) 15/33 (45.5%) 17/29 (58.6%) 3/8 (37.5%) 5/9 (55.6%)
    Neuropathy peripheral0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Paraesthesia0/51 (0%) 1/33 (3%) 5/29 (17.2%) 0/8 (0%) 0/9 (0%)
    Somnolence0/51 (0%) 0/33 (0%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Psychiatric disorders
    Anxiety2/51 (3.9%) 3/33 (9.1%) 2/29 (6.9%) 1/8 (12.5%) 1/9 (11.1%)
    Depression4/51 (7.8%) 1/33 (3%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Insomnia3/51 (5.9%) 2/33 (6.1%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Renal and urinary disorders
    Dysuria4/51 (7.8%) 1/33 (3%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Urinary incontinence0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Reproductive system and breast disorders
    Breast mass1/51 (2%) 0/33 (0%) 1/29 (3.4%) 1/8 (12.5%) 0/9 (0%)
    Dysmenorrhoea4/51 (7.8%) 1/33 (3%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Menstruation irregular0/51 (0%) 0/33 (0%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Vaginal discharge3/51 (5.9%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Vaginal haemorrhage1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Respiratory, thoracic and mediastinal disorders
    Cough16/51 (31.4%) 9/33 (27.3%) 13/29 (44.8%) 1/8 (12.5%) 4/9 (44.4%)
    Dyspnoea4/51 (7.8%) 2/33 (6.1%) 3/29 (10.3%) 1/8 (12.5%) 0/9 (0%)
    Epistaxis5/51 (9.8%) 4/33 (12.1%) 3/29 (10.3%) 0/8 (0%) 1/9 (11.1%)
    Nasal congestion3/51 (5.9%) 2/33 (6.1%) 3/29 (10.3%) 0/8 (0%) 0/9 (0%)
    Oropharyngeal pain10/51 (19.6%) 11/33 (33.3%) 6/29 (20.7%) 1/8 (12.5%) 0/9 (0%)
    Pharyngeal erythema3/51 (5.9%) 5/33 (15.2%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Productive cough1/51 (2%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Respiratory failure0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Respiratory tract congestion0/51 (0%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Rhinalgia0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Rhinitis allergic3/51 (5.9%) 3/33 (9.1%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Rhinorrhoea11/51 (21.6%) 4/33 (12.1%) 3/29 (10.3%) 1/8 (12.5%) 1/9 (11.1%)
    Wheezing3/51 (5.9%) 2/33 (6.1%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Skin and subcutaneous tissue disorders
    Acne1/51 (2%) 7/33 (21.2%) 3/29 (10.3%) 0/8 (0%) 1/9 (11.1%)
    Alopecia5/51 (9.8%) 1/33 (3%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Dermatitis acneiform2/51 (3.9%) 2/33 (6.1%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Dry skin2/51 (3.9%) 0/33 (0%) 4/29 (13.8%) 0/8 (0%) 1/9 (11.1%)
    Eczema1/51 (2%) 1/33 (3%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Erythema4/51 (7.8%) 2/33 (6.1%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Papule1/51 (2%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Petechiae1/51 (2%) 1/33 (3%) 1/29 (3.4%) 0/8 (0%) 1/9 (11.1%)
    Pruritus7/51 (13.7%) 4/33 (12.1%) 5/29 (17.2%) 0/8 (0%) 0/9 (0%)
    Rash14/51 (27.5%) 11/33 (33.3%) 8/29 (27.6%) 1/8 (12.5%) 1/9 (11.1%)
    Rash erythematous3/51 (5.9%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 0/9 (0%)
    Rash maculo-papular0/51 (0%) 3/33 (9.1%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Rash papular3/51 (5.9%) 1/33 (3%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Skin exfoliation0/51 (0%) 0/33 (0%) 1/29 (3.4%) 0/8 (0%) 1/9 (11.1%)
    Skin hypopigmentation1/51 (2%) 0/33 (0%) 2/29 (6.9%) 0/8 (0%) 1/9 (11.1%)
    Skin induration0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Urticaria3/51 (5.9%) 3/33 (9.1%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Xeroderma0/51 (0%) 0/33 (0%) 2/29 (6.9%) 0/8 (0%) 0/9 (0%)
    Vascular disorders
    Haematoma2/51 (3.9%) 3/33 (9.1%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Hot flush0/51 (0%) 0/33 (0%) 0/29 (0%) 0/8 (0%) 1/9 (11.1%)
    Hypertension5/51 (9.8%) 4/33 (12.1%) 1/29 (3.4%) 0/8 (0%) 0/9 (0%)
    Phlebitis0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)
    Thrombophlebitis0/51 (0%) 0/33 (0%) 0/29 (0%) 1/8 (12.5%) 0/9 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

    Results Point of Contact

    Name/TitleBristol-Myers Squibb Study Director
    OrganizationBristol-Myers Squibb
    Phone
    EmailClinical.Trials@bms.com
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT00777036
    Other Study ID Numbers:
    • CA180-226
    • 2008-002260-33
    First Posted:
    Oct 22, 2008
    Last Update Posted:
    Feb 25, 2022
    Last Verified:
    Feb 1, 2022