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Study of INCB053914 in Subjects With Advanced Malignancies

Sponsor
Incyte Corporation (Industry)
Overall Status
Terminated
CT.gov ID
NCT02587598
Collaborator
(none)
97
Enrollment
19
Locations
9
Arms
55.4
Actual Duration (Months)
5.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, dose-escalation study of the proviral integration site of Moloney murine leukemia virus (PIM) kinase inhibitor INCB053914 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (monotherapy dose escalation) will evaluate safety and determine the maximum tolerated dose of INCB053914 monotherapy and the recommended phase 2 dose(s) (a tolerated pharmacologically active dose that will be taken forward into the remaining parts of the study). Part 2 (monotherapy dose expansion) will further evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the recommended Phase 2 dose(s). Part 3 (combination dose finding) will evaluate safety of INCB053914 in combination with select standard of care (SOC) agents and will identify the optimal INCB053914 dose in combination with conventional SOC regimens to take forward into Part 4. Part 4 (combination dose expansion) will further evaluate the safety, efficacy and pharmacokinetics of the recommended Phase 2 dose combination(s).

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
97 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2 Study of INCB053914 in Subjects With Advanced Malignancies
Actual Study Start Date :
Dec 29, 2015
Actual Primary Completion Date :
Aug 11, 2020
Actual Study Completion Date :
Aug 11, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Parts 1 and 2: INCB053914 100 mg QD

INCB053914 will be self-administered orally once a day in as a 100mg immediate release tablet as a monotherapy.

Drug: INCB053914
Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria. INCB053914 tablets to be administered by mouth.
Experimental: Parts 3 and 4: INCB053914 + Azacitidine

Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914.

Drug: INCB053914
Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria. INCB053914 tablets to be administered by mouth.

Drug: Azacitidine
Azacitidine dose will be 75 mg/m^2. Azacitidine will be administered either sub-cutaneously (SC) or intravenously (IV).
Other Names:
  • Vidaza®

    		•
    Experimental: Parts 3 and 4: INCB053914 + I-DAC (Intermediate dose cytarabine)

    I-DAC (intermediate dose cytarabine) will be administered at a dose of 1 g/m2 per day as an infusion as a combination therapy with INCB053914.

    Drug: INCB053914
    Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria. INCB053914 tablets to be administered by mouth.

    Drug: I-DAC (Intermediate dose cytarabine)
    Cytarabine dose will be 1 g/m^2. Cytarabine will be administered as an intravenous (IV) infusion.
    Experimental: Parts 3 and 4: INCB053914 + Ruxolitinib

    Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.

    Drug: INCB053914
    Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria. INCB053914 tablets to be administered by mouth.

    Drug: Ruxolitinib
    Starting dose of ruxolitinib will be the dose the subject was on at study entry Ruxolitinib will be administered by mouth.
    Experimental: Parts 1 and 2: INCB053914 50 mg

    INCB053914 will be self-administered orally twice day in as a 50mg immediate release tablet as a monotherapy.

    Drug: INCB053914
    Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria. INCB053914 tablets to be administered by mouth.
    Experimental: Parts 1 and 2: INB053914 65 mg

    INCB053914 will be self-administered orally twice day in as a 65mg immediate release tablet as a monotherapy.

    Drug: INCB053914
    Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria. INCB053914 tablets to be administered by mouth.
    Experimental: Parts 1 and 2: INB053914 80 mg

    INCB053914 will be self-administered orally twice day in as a 80mg immediate release tablet as a monotherapy.

    Drug: INCB053914
    Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria. INCB053914 tablets to be administered by mouth.
    Experimental: Parts 1 and 2: INB053914 100 mg BID

    INCB053914 will be self-administered orally twice day in as a 100mg immediate release tablet as a monotherapy.

    Drug: INCB053914
    Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria. INCB053914 tablets to be administered by mouth.
    Experimental: Parts 1 and 2: INB053914 115 mg

    INCB053914 will be self-administered orally twice day in as a 115mg immediate release tablet as a monotherapy.

    Drug: INCB053914
    Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria. INCB053914 tablets to be administered by mouth.

    Outcome Measures

    Primary Outcome Measures

    1. Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events [Approximately 7 months]

    2. Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With the Intermediate-dose Cytarabine (I DAC) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) Based on Objective Remission Rate (ORR) [Approximately 2 months]

      The primary efficacy endpoint of ORR in patients with AML who received INCB053914 in combination with cytarabine in Part 4 was not assessed because Part 4 was not opened for enrollment owing to this combination regimen not being tolerated in Part 3.

    3. Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With Azacitidine in Subjects With Newly Diagnosed AML Who Are 65 Years or Older and Unfit for Intensive Chemotherapy Based on ORR [Approximately 6 months]

      The primary efficacy endpoint of ORR in patients with AML who received INCB053914 plus azacitidine in Part 4 was not performed due to limited enrollment as a result of early study termination.

    Secondary Outcome Measures

    1. Evaluation of Phosphorylated BCL--2 Associated Death Promoter Protein (pBAD) [1 month]

      Percent Inhibition of pBAD at the C1D15 trough from the pBAD at pre-dose by ex vivo cellular assay

    2. Pharmacokinetics: Tmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine [Cycle 1 Day 5]

    3. Pharmacokinetics: AUCtau of Combination Treatment Group A INCB053914 50 mg + Cytarabine [Cycle 1 Day 5]

    4. Pharmacokinetics: Cl/F of Combination Treatment Group A INCB053914 50 mg + Cytarabine [Cycle 1 Day 5]

    5. Pharmacokinetics: Cmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine [Cycle 1 Day 5]

    6. Pharmacokinetics: Cmin of Combination Treatment Group A INCB053914 50 mg + Cytarabine [Cycle 1 Day 5]

    7. Pharmacokinetics: Tmax of Combination Group B INCB053914 80 mg + Azatcitidine [Cycle 1 Day 8]

    8. Pharmacokinetics: AUCtau of Combination Group B INCB053914 80 mg + Azatcitidine [Cycle 1 Day 8]

    9. Pharmacokinetics: Cl/F of Combination Group B INCB053914 80 mg + Azatcitidine [Cycle 1 Day 8]

    10. Pharmacokinetics: Cmax of Combination Group B INCB053914 80 mg + Azatcitidine [Cycle 1 Day 8]

    11. Pharmacokinetics: Cmin of Combination Group B INCB053914 80 mg + Azatcitidine [Cycle 1 Day 8]

    12. Pharmacokinetics: Tmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib [Regimen 2 Week 4]

    13. Pharmacokinetics: AUCtau of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib [Regimen 2 Week 4]

    14. Pharmacokinetics: Cl/F of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib [Regimen 2 Week 4]

    15. Pharmacokinetics: Cmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib [Regimen 2 Week 4]

    16. Pharmacokinetics: Cmin of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib [Regimen 2 Week 4]

    17. Pharmacokinetics: Tmax of INCB053914 Monotherapy [Cycle 1 Day 8]

    18. Pharmacokinetics: AUCtau of INCB053914 Monotherapy [Cycle 1 Day 8]

    19. Pharmacokinetics: CL/F of INCB053914 Monotherapy [Cycle 1 Day 8]

    20. Pharmacokinetics: Cmax of INCB053914 Monotherapy [Cycle 1 Day 8]

    21. Pharmacokinetics: Ctau of INCB053914 Monotherapy [Cycle 1 Day 8]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Aged 18 years or older

    • Confirmed diagnosis of select advanced malignancy

    • Parts 1 and 2:

    • Unresponsive to currently available therapy and there is no standard-of-care therapy available in the judgment of the investigator.

    • Not currently a candidate for curative treatment

    • Parts 3 and 4:

    • Subjects with relapsed/refractory AML must have received either induction chemotherapy for AML or hypomethylating agents for hematologic disease before AML.

    • Elderly subjects (≥ 65 years) with newly diagnosed AML must be treatment naive and unfit for intensive chemotherapy.

    • Myelofibrosis subjects must have been treated with ruxolitinib for ≥ 6 months with a stable dose for ≥ 8 weeks (acceptable doses are 5 mg twice daily [BID] to 25 mg BID).

    • Willingness to undergo a pretreatment bone marrow biopsy and/or aspirate, or archival sample obtained since completion of most recent therapy (as appropriate to subjects with existing bone marrow disease or for whom bone marrow examination is a component of disease status assessment)

    • Eastern Cooperative Oncology Group (ECOG) performance status

    • Part 1: 0 or 1

    • Parts 2, 3 and 4: 0, 1, or 2

    • Life expectancy > 12 weeks or ≥ 24 weeks for Part 3 and Part 4 MF subjects.

    Exclusion Criteria:

    • Inadequate bone marrow or organ function

    • Received an investigational agent within 5 half-lives or 14 days, whichever is longer, prior to receiving the first dose of study drug

    • Received non-biologic anticancer medication within 5 half-lives prior to receiving the first dose of study drug (within 6 weeks for mitomycin-C or nitrosoureas), within 28 days for any antibodies or biological therapies

    • Prior receipt of a PIM inhibitor

    • Any history of disease involving the central nervous system (Part 1). Known active disease involving the central nervous system (Part 2).

    • Screening corrected QT interval (QTc) interval > 470 milliseconds

    • Radiotherapy within the 2 weeks prior to initiation of treatment

    • Chronic or current active infection requiring systemic antibiotic, antifungal, or antiviral treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Arizona Cancer Center Tucson Arizona United States 85719
    2 UC Davis comprehensive Cancer Center Sacramento California United States 95817
    3 UCLA Medical Hematology & Oncology Santa Monica California United States 90095
    4 Yale University New Haven Connecticut United States 06511
    5 Mayo Clinic Florida Jacksonville Florida United States 32224
    6 Florida Cancer Specialists & Research Institute Sarasota Florida United States 33916
    7 H. Lee Moffitt Cancer Center & Research Institute Tampa Florida United States 33612
    8 Emory University-Winship Cancer Institute Atlanta Georgia United States 30322
    9 University of Maryland Baltimore Maryland United States 21201
    10 Dana-Farber Cancer Center Boston Massachusetts United States 02215
    11 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    12 University of Nebraska Medical Center Omaha Nebraska United States 69198
    13 Oncology Hematology Care Clinical Trials LLC Cincinnati Ohio United States 45236
    14 Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
    15 Tennessee Oncology Nashville Tennessee United States 37203
    16 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    17 Texas Oncology Austin Texas United States 78705
    18 Texas Oncology Tyler Texas United States 75702
    19 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Fred Zheng, M.D., Incyte Corporation

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT02587598
    Other Study ID Numbers:
    • INCB 53914-101
    First Posted:
    Oct 27, 2015
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    leukemia
    myelodysplastic syndrome (MDS)
    myelodysplastic/myeloproliferative neoplasms (MDS/MPN)
    myelofibrosis (MF)
    lymphoproliferative disorders
    acute myeloid leukemia (AML)
    lymphomas
    multiple myeloma (MM)
    PIM kinases
    Additional relevant MeSH terms:
    Neoplasms
    Cytarabine
    Azacitidine

    Study Results

    Participant Flow

    Recruitment Details This study was conducted in 18 US centers and consisted of 4 parts: Parts 1 and 2 evaluated INCB053914 as a monotherapy, and Parts 3 and 4 evaluated INCB053914 as part of a combination therapy with select standard-of-care agents (cytarabine, azacitidine, and ruxolitinib) in participants with advanced malignancies. Note:The study was terminated early based on strategic business decisions and not due to concerns with the safety and tolerability of INCB053914.
    Pre-assignment Detail A total of 58 participants were enrolled and treated in Parts 1 and 2 combined and were included in the safety population and the full analysis set. A total of 39 participants enrolled and treated in Parts 3 and 4 combined were included in the safety population and the full analysis set.
    Arm/Group Title Parts 1 and 2: INCB053914 100 mg QD Parts 1 and 2: INCB053914 50 mg BID Parts 1 and 2: INB053914 65 mg BID Parts 1 and 2: INB053914 80 mg BID Parts 1 and 2: INB053914 100 mg BID Parts 1 and 2: INB053914 115 mg BID Parts 3 and 4: INCB053914 50 mg BID + Cytarabine Parts 3 and 4: INCB053914 50 mg BID + Azacitidine Part 3 and 4 - INCB053914 80 mg BID + Azacitidine Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib
    Arm/Group Description INCB053914 was self-administered orally once a day as a 100mg immediate release monotherapy dose. INCB053914 was self-administered orally twice day as a 50mg immediate release monotherapy dose. INCB053914 was self-administered orally twice day as a 65mg immediate release monotherapy dose. INCB053914 was self-administered orally twice day as a 80mg immediate release monotherapy dose. INCB053914 was self-administered orally twice day as a 100mg immediate release monotherapy dose. INCB053914 was self-administered orally twice day as a 115mg immediate release monotherapy dose. Combination Treatment Group A: 50 mg twice a day + I-DAC (intermediate dose cytarabine) was administered at a dose of 1 g/m2 as an infusion as a combination therapy with INCB053914. Combination Treatment Group B: INCB053914 50 mg twice a day + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914. Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine was administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914. Combination Treatment Group C: INCB053914 50 mg + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914. Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib was administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914.
    Period Title: Overall Study
    STARTED 4 11 4 21 12 6 6 7 9 3 14
    COMPLETED 0 0 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 4 11 4 21 12 6 6 7 9 3 14

    Baseline Characteristics

    Arm/Group Title Parts 1 and 2: INCB053914 100 mg QD Parts 1 and 2: INCB053914 50 mg BID Parts 1 and 2: INB053914 65 mg BID Parts 1 and 2: INB053914 80 mg BID Parts 1 and 2: INB053914 100 mg BID Parts 1 and 2: INB053914 115 mg BID Parts 3 and 4: INCB053914 50 mg BID + Cytarabine Parts 3 and 4: INCB053914 50 mg BID + Azacitidine Part 3 and 4 - INCB053914 80 mg BID + Azacitidine Part 3 and 4: INCB053914 50 mg BID + Ruxolitinib Part 3 and 4: INCB053914 80 mg BID + Ruxolitinib Total
    Arm/Group Description INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 65mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 80mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day s a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose. Combination Treatment Group A: 50 mg BID + I-DAC (intermediate dose cytarabine) will be administered at a dose of 1 g/m2 per day as an infusion as a combination therapy with INCB053914. Combination Treatment Group B: Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914 50 mg BID. Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine will be administered at a dose of 75 mg/m2 subcutaneously or via IV per day, as a combination therapy with INCB053914. Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914. Combination Treatment Group C: INCB053914 80 mg + Ruxolitinib will be administered as an oral dose between 5 mg to 25 mg twice per day, as a combination therapy with INCB053914. Total of all reporting groups
    Overall Participants 4 11 4 21 12 6 6 7 9 3 14 97
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    59.5
    (14.25)
    67.1
    (14.64)
    67.3
    (9.18)
    70.8
    (11.50)
    76.5
    (7.19)
    70.5
    (9.67)
    70.8
    (6.46)
    60.9
    (20.83)
    72.9
    (6.31)
    70.0
    (5.0)
    72.6
    (7.48)
    70.2
    (11.38)
    Sex: Female, Male (Count of Participants)
    Female
    3
    75%
    5
    45.5%
    2
    50%
    11
    52.4%
    3
    25%
    3
    50%
    5
    83.3%
    5
    71.4%
    2
    22.2%
    2
    66.7%
    6
    42.9%
    47
    48.5%
    Male
    1
    25%
    6
    54.5%
    2
    50%
    10
    47.6%
    9
    75%
    3
    50%
    1
    16.7%
    2
    28.6%
    7
    77.8%
    1
    33.3%
    8
    57.1%
    50
    51.5%
    Race/Ethnicity, Customized (Count of Participants)
    White/Caucasian
    4
    100%
    11
    100%
    1
    25%
    16
    76.2%
    11
    91.7%
    5
    83.3%
    4
    66.7%
    7
    100%
    8
    88.9%
    3
    100%
    13
    92.9%
    83
    85.6%
    Black/African American
    0
    0%
    0
    0%
    3
    75%
    4
    19%
    1
    8.3%
    1
    16.7%
    1
    16.7%
    0
    0%
    1
    11.1%
    0
    0%
    0
    0%
    11
    11.3%
    Other
    0
    0%
    0
    0%
    0
    0%
    1
    4.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1%
    Native Hawaiian/Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    7.1%
    1
    1%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    1
    25%
    0
    0%
    0
    0%
    1
    4.8%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    7.1%
    3
    3.1%
    Not Hispanic or Latino
    3
    75%
    11
    100%
    4
    100%
    18
    85.7%
    12
    100%
    6
    100%
    6
    100%
    7
    100%
    8
    88.9%
    3
    100%
    11
    78.6%
    89
    91.8%
    Unknown
    0
    0%
    0
    0%
    0
    0%
    2
    9.5%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    11.1%
    0
    0%
    2
    14.3%
    5
    5.2%

    Outcome Measures

    1. Primary Outcome
    Title Determination of the Safety and Tolerability of INCB053914 as Measured by the Number of Participants With Adverse Events
    Description
    Time Frame Approximately 7 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 1 and 2: INCB053914 100 mg QD Parts 1 and 2: INCB053914 50 mg BID Parts 1 and 2: INB053914 65 mg BID Parts 1 and 2: INB053914 80 mg BID Parts 1 and 2: INB053914 100 mg BID Parts 1 and 2: INB053914 115 mg BID Parts 3 and 4: INCB053914 50 mg BID + Cytarabine Parts 3 and 4: INCB053914 50 mg BID + Azacitidine Parts 3 and 4: INCB053914 80 mg BID + Azacitine Parts 3 & 4: INCB 053914 50 mg BID + Ruxolitinib Parts 3 & 4: INCB 053914 80 mg + Ruxolitinib
    Arm/Group Description INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose. Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine Combination Treatment Group B: INCB053914 50 mg BID + Azacitidine Combination Treatment Group B: INCB053914 80 mg BID + Azacitine Combination Treatment Group C: INCB053914 50 mg BID + Ruxolitinib Combination Treatment Group C: INCB 053914 80 mg BID + Ruxolitinib
    Measure Participants 4 11 4 21 12 3 6 7 9 3 14
    Number [Participants]
    4
    100%
    11
    100%
    4
    100%
    21
    100%
    12
    100%
    6
    100%
    6
    100%
    7
    100%
    9
    100%
    3
    100%
    14
    100%
    2. Primary Outcome
    Title Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With the Intermediate-dose Cytarabine (I DAC) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) Based on Objective Remission Rate (ORR)
    Description The primary efficacy endpoint of ORR in patients with AML who received INCB053914 in combination with cytarabine in Part 4 was not assessed because Part 4 was not opened for enrollment owing to this combination regimen not being tolerated in Part 3.
    Time Frame Approximately 2 months

    Outcome Measure Data

    Analysis Population Description
    Part 4 was not opened for enrollment owing to combination regimen not being tolerated in Part 3.
    Arm/Group Title Part 4: INCB053914 50 mg BID + Cytarabine)
    Arm/Group Description Combination Treatment Group A: INCB053914 50 mg BID + Cytarabine
    Measure Participants 0
    3. Primary Outcome
    Title Part 4 Only : Determination of the Efficacy of INCB053914 in Combination With Azacitidine in Subjects With Newly Diagnosed AML Who Are 65 Years or Older and Unfit for Intensive Chemotherapy Based on ORR
    Description The primary efficacy endpoint of ORR in patients with AML who received INCB053914 plus azacitidine in Part 4 was not performed due to limited enrollment as a result of early study termination.
    Time Frame Approximately 6 months

    Outcome Measure Data

    Analysis Population Description
    Part 4 was not opened for enrollment.
    Arm/Group Title Part 4: INCB053914 50 mg BID + Azacitidine Part 4: INB053914 80 mg BID + Azactidine
    Arm/Group Description Combination Treatment Group B INCB053914 50 mg BID + Azacitidine Combination Treatment Group B: B053914 80 mg BID + Azactidine
    Measure Participants 0 0
    4. Secondary Outcome
    Title Evaluation of Phosphorylated BCL--2 Associated Death Promoter Protein (pBAD)
    Description Percent Inhibition of pBAD at the C1D15 trough from the pBAD at pre-dose by ex vivo cellular assay
    Time Frame 1 month

    Outcome Measure Data

    Analysis Population Description
    The PD evaluable population includes those in the safety population who have at least 1 valid PD measurements at both pre- and postdose.
    Arm/Group Title Parts 1 and 2: INCB053914 100 mg QD Parts 1 and 2: INCB053914 50 mg BID Parts 1 and 2: INB053914 65 mg BID Parts 1 and 2: INB053914 80 mg BID Parts 1 and 2: INB053914 100 mg BID Parts 1 and 2: INB053914 115 mg BID
    Arm/Group Description INCB053914 will be self-administered orally once a day in as a 100mg immediate release tablet as a monotherapy. INCB053914 will be self-administered orally twice day in as a 50mg immediate release tablet as a monotherapy. INCB053914 will be self-administered orally twice day in as a 65mg immediate release tablet as a monotherapy. INCB053914 will be self-administered orally twice day in as a 80mg immediate release tablet as a monotherapy. INCB053914 will be self-administered orally twice day in as a 100mg immediate release tablet as a monotherapy. INCB053914 will be self-administered orally twice day in as a 115mg immediate release tablet as a monotherapy.
    Measure Participants 4 10 3 3 8 3
    Mean (Full Range) [Percentage of Inhibition]
    41
    37
    68
    78
    55
    58
    5. Secondary Outcome
    Title Pharmacokinetics: Tmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine
    Description
    Time Frame Cycle 1 Day 5

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INCB053914 50 mg BID + Cytarabine
    Arm/Group Description Combination Group A: INCB053914 50 mg BID + Cytarabine
    Measure Participants 6
    Median (Full Range) [h]
    1.52
    6. Secondary Outcome
    Title Pharmacokinetics: AUCtau of Combination Treatment Group A INCB053914 50 mg + Cytarabine
    Description
    Time Frame Cycle 1 Day 5

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INCB053914 50 mg BID + Cytarabine
    Arm/Group Description Combination Group A: INCB053914 50 mg BID + Cytarabine
    Measure Participants 6
    Mean (Standard Deviation) [nM*h]
    2860
    (2040)
    7. Secondary Outcome
    Title Pharmacokinetics: Cl/F of Combination Treatment Group A INCB053914 50 mg + Cytarabine
    Description
    Time Frame Cycle 1 Day 5

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INCB053914 50 mg BID + Cytarabine
    Arm/Group Description Combination Group A: INCB053914 50 mg BID + Cytarabine
    Measure Participants 6
    Mean (Standard Deviation) [L/hr]
    122
    (213)
    8. Secondary Outcome
    Title Pharmacokinetics: Cmax of Combination Treatment Group A INCB053914 50 mg + Cytarabine
    Description
    Time Frame Cycle 1 Day 5

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INCB053914 50 mg BID + Cytarabine
    Arm/Group Description Combination Group A: INCB053914 50 mg BID + Cytarabine
    Measure Participants 6
    Mean (Standard Deviation) [nM]
    423
    (283)
    9. Secondary Outcome
    Title Pharmacokinetics: Cmin of Combination Treatment Group A INCB053914 50 mg + Cytarabine
    Description
    Time Frame Cycle 1 Day 5

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INCB053914 50 mg BID + Cytarabine
    Arm/Group Description Combination Group A: INCB053914 50 mg BID + Cytarabine
    Measure Participants 6
    Mean (Standard Deviation) [nM]
    139
    (101)
    10. Secondary Outcome
    Title Pharmacokinetics: Tmax of Combination Group B INCB053914 80 mg + Azatcitidine
    Description
    Time Frame Cycle 1 Day 8

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INCB053914 80 mg BID + Azacitidine
    Arm/Group Description Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine
    Measure Participants 7
    Median (Full Range) [h]
    2
    11. Secondary Outcome
    Title Pharmacokinetics: AUCtau of Combination Group B INCB053914 80 mg + Azatcitidine
    Description
    Time Frame Cycle 1 Day 8

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INCB053914 80 mg BID + Azacitidine
    Arm/Group Description Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine
    Measure Participants 7
    Mean (Standard Deviation) [nM*h]
    11000
    (11100)
    12. Secondary Outcome
    Title Pharmacokinetics: Cl/F of Combination Group B INCB053914 80 mg + Azatcitidine
    Description
    Time Frame Cycle 1 Day 8

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INCB053914 80 mg BID + Azacitidine
    Arm/Group Description Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine
    Measure Participants 7
    Mean (Standard Deviation) [L/h]
    30.8
    (24.7)
    13. Secondary Outcome
    Title Pharmacokinetics: Cmax of Combination Group B INCB053914 80 mg + Azatcitidine
    Description
    Time Frame Cycle 1 Day 8

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INCB053914 80 mg BID + Azacitidine
    Arm/Group Description Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine
    Measure Participants 7
    Mean (Standard Deviation) [nM]
    1320
    (1240)
    14. Secondary Outcome
    Title Pharmacokinetics: Cmin of Combination Group B INCB053914 80 mg + Azatcitidine
    Description
    Time Frame Cycle 1 Day 8

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INCB053914 80 mg BID + Azacitidine
    Arm/Group Description Combination Treatment Group B: INCB053914 80 mg BID + Azacitidine
    Measure Participants 7
    Mean (Standard Deviation) [nM]
    513
    (431)
    15. Secondary Outcome
    Title Pharmacokinetics: Tmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
    Description
    Time Frame Regimen 2 Week 4

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INB053914 80 mg BID + Ruxolitinib
    Arm/Group Description Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib
    Measure Participants 6
    Median (Full Range) [h]
    2.02
    16. Secondary Outcome
    Title Pharmacokinetics: AUCtau of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
    Description
    Time Frame Regimen 2 Week 4

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INB053914 80 mg BID + Ruxolitinib
    Arm/Group Description Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib
    Measure Participants 6
    Mean (Standard Deviation) [nM*h]
    3060
    (1730)
    17. Secondary Outcome
    Title Pharmacokinetics: Cl/F of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
    Description
    Time Frame Regimen 2 Week 4

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INB053914 80 mg BID + Ruxolitinib
    Arm/Group Description Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib
    Measure Participants 6
    Mean (Standard Deviation) [L/h]
    69.7
    (41.1)
    18. Secondary Outcome
    Title Pharmacokinetics: Cmax of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
    Description
    Time Frame Regimen 2 Week 4

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INB053914 80 mg BID + Ruxolitinib
    Arm/Group Description Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib
    Measure Participants 6
    Mean (Standard Deviation) [nM]
    541
    (376)
    19. Secondary Outcome
    Title Pharmacokinetics: Cmin of Combination Treatment Group C INCB053914 80 mg + Ruxolitinib
    Description
    Time Frame Regimen 2 Week 4

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 3 & 4: INB053914 80 mg BID + Ruxolitinib
    Arm/Group Description Combination Treatment Group C: INCB053914 80 mg BID + Ruxolitinib
    Measure Participants 6
    Mean (Standard Deviation) [nM]
    104
    (63.7)
    20. Secondary Outcome
    Title Pharmacokinetics: Tmax of INCB053914 Monotherapy
    Description
    Time Frame Cycle 1 Day 8

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 1 and 2: INCB053914 100 mg QD Parts 1 and 2: INCB053914 50 mg BID Parts 1 and 2: INB053914 65 mg BID Parts 1 and 2: INB053914 80 mg BID Parts 1 and 2: INB053914 100 mg BID Parts 1 and 2: INB053914 115 mg BID
    Arm/Group Description INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
    Measure Participants 3 8 3 14 11 2
    Median (Full Range) [hour]
    2.0
    1.0
    2.0
    1.5
    1.0
    NA
    21. Secondary Outcome
    Title Pharmacokinetics: AUCtau of INCB053914 Monotherapy
    Description
    Time Frame Cycle 1 Day 8

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 1 and 2: INCB053914 100 mg QD Parts 1 and 2: INCB053914 50 mg BID Parts 1 and 2: INB053914 65 mg BID Parts 1 and 2: INB053914 80 mg BID Parts 1 and 2: INB053914 100 mg BID Parts 1 and 2: INB053914 115 mg BID
    Arm/Group Description INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
    Measure Participants 3 8 3 14 11 2
    Mean (Standard Deviation) [nM*h]
    4140
    (282)
    1290
    (924)
    2480
    (2470)
    3940
    (3120)
    5410
    (5060)
    5630
    (764)
    22. Secondary Outcome
    Title Pharmacokinetics: CL/F of INCB053914 Monotherapy
    Description
    Time Frame Cycle 1 Day 8

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 1 and 2: INCB053914 100 mg QD Parts 1 and 2: INCB053914 50 mg BID Parts 1 and 2: INB053914 65 mg BID Parts 1 and 2: INB053914 80 mg BID Parts 1 and 2: INB053914 100 mg BID Parts 1 and 2: INB053914 115 mg BID
    Arm/Group Description INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
    Measure Participants 3 8 3 14 11 2
    Mean (Standard Deviation) [L/h]
    47.2
    (3.16)
    132
    (132)
    95.1
    (73.2)
    71.2
    (58.5)
    85.2
    (114)
    39.8
    (293)
    23. Secondary Outcome
    Title Pharmacokinetics: Cmax of INCB053914 Monotherapy
    Description
    Time Frame Cycle 1 Day 8

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Parts 1 and 2: INCB053914 100 mg QD Parts 1 and 2: INCB053914 50 mg BID Parts 1 and 2: INB053914 65 mg BID Parts 1 and 2: INB053914 80 mg BID Parts 1 and 2: INB053914 100 mg BID Parts 1 and 2: INB053914 115 mg BID
    Arm/Group Description INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
    Measure Participants 3 8 3 14 11 2
    Mean (Standard Deviation) [nM]
    352
    (126)
    227
    (188)
    333
    (276)
    591
    (447)
    796
    (659)
    578
    (131)
    24. Secondary Outcome
    Title Pharmacokinetics: Ctau of INCB053914 Monotherapy
    Description
    Time Frame Cycle 1 Day 8

    Outcome Measure Data

    Analysis Population Description
    Ctau was calculated using the predose value on C1D8
    Arm/Group Title Parts 1 and 2: INCB053914 100 mg QD Parts 1 and 2: INCB053914 50 mg BID Parts 1 and 2: INB053914 65 mg BID Parts 1 and 2: INB053914 80 mg BID Parts 1 and 2: INB053914 100 mg BID Parts 1 and 2: INB053914 115 mg BID
    Arm/Group Description INCB053914 will be self-administered orally once a day as a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 50mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day in as a 65mg immediate release monotherapy dose INCB053914 will be self-administered orally twice day in as a 80mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 100mg immediate release monotherapy dose. INCB053914 will be self-administered orally twice day as a 115mg immediate release monotherapy dose.
    Measure Participants 3 9 3 14 11 5
    Mean (Standard Deviation) [L/h]
    98.2
    (44.9)
    65.7
    (44.2)
    132
    (148)
    213
    (188)
    293
    (322)
    410
    (482)

    Adverse Events

    Time Frame up to approximately 6 months
    Adverse Event Reporting Description
    Arm/Group Title Part 1 and 2 - INCB053914: 100 mg QD Part 1 and 2 - INCB053914: 50 mg BID Part 1 and 2 - INCB053914: 65 mg BID Part 1 and 2 - INCB053914: 80 mg BID Part 1 and 2 - INCB053914: 100 mg BID Part 1 and 2 - INCB053914: 115 mg BID Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
    Arm/Group Description Part 1 and 2 - INCB053914: 100 mg QD Part 1 and 2 - INCB053914: 50 mg BID Part 1 and 2 - INCB053914: 65 mg BID Part 1 and 2 - INCB053914: 80 mg BID Part 1 and 2 - INCB053914: 100 mg BID Part 1 and 2 - INCB053914: 115 mg BID Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
    All Cause Mortality
    Part 1 and 2 - INCB053914: 100 mg QD Part 1 and 2 - INCB053914: 50 mg BID Part 1 and 2 - INCB053914: 65 mg BID Part 1 and 2 - INCB053914: 80 mg BID Part 1 and 2 - INCB053914: 100 mg BID Part 1 and 2 - INCB053914: 115 mg BID Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/4 (100%) 8/11 (72.7%) 4/4 (100%) 19/21 (90.5%) 9/12 (75%) 4/6 (66.7%) 6/6 (100%) 7/7 (100%) 9/9 (100%) 1/3 (33.3%) 3/14 (21.4%)
    Serious Adverse Events
    Part 1 and 2 - INCB053914: 100 mg QD Part 1 and 2 - INCB053914: 50 mg BID Part 1 and 2 - INCB053914: 65 mg BID Part 1 and 2 - INCB053914: 80 mg BID Part 1 and 2 - INCB053914: 100 mg BID Part 1 and 2 - INCB053914: 115 mg BID Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/4 (75%) 6/11 (54.5%) 3/4 (75%) 6/21 (28.6%) 8/12 (66.7%) 5/6 (83.3%) 5/6 (83.3%) 5/7 (71.4%) 6/9 (66.7%) 0/3 (0%) 5/14 (35.7%)
    Blood and lymphatic system disorders
    Anaemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 1/6 (16.7%) 3 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Febrile neutropenia 1/4 (25%) 2 3/11 (27.3%) 4 1/4 (25%) 1 1/21 (4.8%) 1 2/12 (16.7%) 3 2/6 (33.3%) 3 1/6 (16.7%) 1 3/7 (42.9%) 4 3/9 (33.3%) 3 0/3 (0%) 0 0/14 (0%) 0
    Leukocytosis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Neutropenia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Thrombocytopenia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 2 0/7 (0%) 0 1/9 (11.1%) 4 0/3 (0%) 0 1/14 (7.1%) 1
    Cardiac disorders
    Atrial fibrillation 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Cardiac failure congestive 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 2 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Pericardial effusion 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Sinus tachycardia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Gastrointestinal disorders
    Colitis 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Intestinal obstruction 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Abdominal pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Gastrointestinal haemorrhage 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 2 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Lower gastrointestinal haemorrhage 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 2 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Nausea 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Upper gastrointestinal haemorrhage 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    General disorders
    Disease progression 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 2/21 (9.5%) 2 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 3/7 (42.9%) 3 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Multi-organ failure 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Pyrexia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 1/12 (8.3%) 2 2/6 (33.3%) 2 0/6 (0%) 0 1/7 (14.3%) 1 1/9 (11.1%) 2 0/3 (0%) 0 0/14 (0%) 0
    Fatigue 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Malaise 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Infections and infestations
    Bacteraemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Device related infection 1/4 (25%) 2 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Infective myositis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Pneumonia 1/4 (25%) 1 2/11 (18.2%) 2 1/4 (25%) 1 1/21 (4.8%) 1 3/12 (25%) 3 1/6 (16.7%) 1 0/6 (0%) 0 1/7 (14.3%) 1 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Pneumonia fungal 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Pseudomonal bacteraemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Sepsis 1/4 (25%) 1 3/11 (27.3%) 3 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 2/6 (33.3%) 2 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 2/14 (14.3%) 2
    Staphylococcal skin infection 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Upper respiratory tract infection 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Bacterial sepsis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Bursitis infective 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Cellulitis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Clostridium difficile colitis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Clostridium difficile infection 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Escherichia infection 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Otitis externa 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Peritonitis bacterial 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Sialoadenitis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Urinary tract infection 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 3 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Injury, poisoning and procedural complications
    Fall 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Subdural haematoma 0/4 (0%) 0 1/11 (9.1%) 1 1/4 (25%) 1 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Investigations
    Alanine aminotransferase increased 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Aspartate aminotransferase increased 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 2
    Platelet count decreased 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 2
    Blood alkaline phosphatase increased 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Metabolism and nutrition disorders
    Hyperuricaemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Hyponatraemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Decreased appetite 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Failure to thrive 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Back pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Muscular weakness 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Pain in extremity 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Plasmacytoma 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Blast cell crisis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Nervous system disorders
    Carotid artery occlusion 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Headache 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Syncope 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Psychiatric disorders
    Confusional state 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Mental status changes 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Renal and urinary disorders
    Acute kidney injury 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Dysuria 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 2 0/3 (0%) 0 0/14 (0%) 0
    Haematuria 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/9 (22.2%) 3 0/3 (0%) 0 0/14 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Respiratory failure 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Pleural effusion 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Pulmonary embolism 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Pulmonary mass 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Pulmonary oedema 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Skin and subcutaneous tissue disorders
    Acute febrile neutrophilic dermatosis 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Rash maculo-papular 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 2/6 (33.3%) 2 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Vascular disorders
    Haemorrhagic infarction 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Haemorrhage 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Hypotension 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Other (Not Including Serious) Adverse Events
    Part 1 and 2 - INCB053914: 100 mg QD Part 1 and 2 - INCB053914: 50 mg BID Part 1 and 2 - INCB053914: 65 mg BID Part 1 and 2 - INCB053914: 80 mg BID Part 1 and 2 - INCB053914: 100 mg BID Part 1 and 2 - INCB053914: 115 mg BID Part 3 and 4 - INCB053914: 50 mg BID + Cytarabine Part 3 and 4 - INCB053914: 50 mg BID + Azacitidine Part 3 and 4 - INCB053914: 80 mg BID + Azacitidine Part 3 and 4 - INCB053914: 50 mg BID + Ruxolitinib Part 3 and 4 - INCB053914: 80 mg BID + Ruxolitinib
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/4 (100%) 11/11 (100%) 4/4 (100%) 20/21 (95.2%) 12/12 (100%) 6/6 (100%) 6/6 (100%) 7/7 (100%) 8/9 (88.9%) 3/3 (100%) 14/14 (100%)
    Blood and lymphatic system disorders
    Anaemia 2/4 (50%) 3 2/11 (18.2%) 2 3/4 (75%) 4 5/21 (23.8%) 10 5/12 (41.7%) 22 2/6 (33.3%) 2 3/6 (50%) 9 3/7 (42.9%) 4 3/9 (33.3%) 3 1/3 (33.3%) 4 5/14 (35.7%) 9
    Febrile neutropenia 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 0/12 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 1/7 (14.3%) 1 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Increased tendency to bruise 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Leukocytosis 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Neutropenia 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 2/21 (9.5%) 2 0/12 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2 1/7 (14.3%) 1 3/9 (33.3%) 7 0/3 (0%) 0 1/14 (7.1%) 1
    Thrombocytopenia 0/4 (0%) 0 2/11 (18.2%) 2 1/4 (25%) 1 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 1/7 (14.3%) 2 4/9 (44.4%) 7 0/3 (0%) 0 5/14 (35.7%) 9
    Splenomegaly 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 2/14 (14.3%) 2
    Cardiac disorders
    Sinus tachycardia 1/4 (25%) 1 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Tachycardia 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 1/21 (4.8%) 1 0/12 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Atrial fibrillation 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 2/9 (22.2%) 2 0/3 (0%) 0 0/14 (0%) 0
    Bradycardia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Ear and labyrinth disorders
    Hearing impaired 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Eye disorders
    Erythema of eyelid 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Eye pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 1/3 (33.3%) 2 0/14 (0%) 0
    Retinal tear 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Vision blurred 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Gastrointestinal disorders
    Abdominal distension 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 2/6 (33.3%) 2 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Abdominal pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 4/21 (19%) 4 3/12 (25%) 3 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 3/9 (33.3%) 4 1/3 (33.3%) 1 1/14 (7.1%) 1
    Abdominal pain lower 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Abdominal pain upper 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 2/12 (16.7%) 2 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Constipation 1/4 (25%) 1 1/11 (9.1%) 1 0/4 (0%) 0 1/21 (4.8%) 1 3/12 (25%) 3 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 6/9 (66.7%) 6 1/3 (33.3%) 1 2/14 (14.3%) 2
    Diarrhoea 2/4 (50%) 2 2/11 (18.2%) 2 1/4 (25%) 2 4/21 (19%) 4 3/12 (25%) 4 3/6 (50%) 4 4/6 (66.7%) 5 3/7 (42.9%) 5 3/9 (33.3%) 5 0/3 (0%) 0 1/14 (7.1%) 1
    Dysphagia 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/9 (22.2%) 2 0/3 (0%) 0 1/14 (7.1%) 1
    Gastrointestinal haemorrhage 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 2/12 (16.7%) 3 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Gastrooesophageal reflux disease 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Gingival bleeding 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Nausea 3/4 (75%) 3 4/11 (36.4%) 6 1/4 (25%) 1 4/21 (19%) 4 3/12 (25%) 5 2/6 (33.3%) 2 0/6 (0%) 0 0/7 (0%) 0 2/9 (22.2%) 4 0/3 (0%) 0 2/14 (14.3%) 3
    Sensitivity of teeth 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Stomatitis 1/4 (25%) 1 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Toothache 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Vomiting 0/4 (0%) 0 2/11 (18.2%) 2 1/4 (25%) 1 0/21 (0%) 0 3/12 (25%) 3 1/6 (16.7%) 2 0/6 (0%) 0 0/7 (0%) 0 2/9 (22.2%) 4 0/3 (0%) 0 3/14 (21.4%) 4
    Dry mouth 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Dyspepsia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/9 (22.2%) 2 1/3 (33.3%) 1 0/14 (0%) 0
    Flatulence 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Haematochezia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Haemorrhoidal haemorrhage 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Haemorrhoids 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Ileus 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Melaena 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Mouth haemorrhage 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Oesophagitis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Oral disorder 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Oral pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Tongue blistering 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    General disorders
    Asthenia 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 2/12 (16.7%) 2 0/6 (0%) 0 2/6 (33.3%) 2 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Chest pain 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Chills 1/4 (25%) 1 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/9 (22.2%) 3 0/3 (0%) 0 0/14 (0%) 0
    Fatigue 4/4 (100%) 4 4/11 (36.4%) 4 1/4 (25%) 1 5/21 (23.8%) 6 6/12 (50%) 6 1/6 (16.7%) 1 1/6 (16.7%) 1 3/7 (42.9%) 3 4/9 (44.4%) 4 0/3 (0%) 0 2/14 (14.3%) 2
    Gait disturbance 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Influenza like illness 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Malaise 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Medical device complication 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Oedema peripheral 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 1/12 (8.3%) 1 0/6 (0%) 0 2/6 (33.3%) 5 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 3/14 (21.4%) 3
    Pyrexia 2/4 (50%) 2 1/11 (9.1%) 1 2/4 (50%) 2 2/21 (9.5%) 2 2/12 (16.7%) 2 0/6 (0%) 0 2/6 (33.3%) 3 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Early satiety 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 2/14 (14.3%) 2
    Injection site pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Injection site reaction 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Localised oedema 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Non-cardiac chest pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/9 (22.2%) 2 0/3 (0%) 0 0/14 (0%) 0
    Suprapubic pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Hepatobiliary disorders
    Hyperbilirubinaemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Hepatic cirrhosis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Immune system disorders
    Drug hypersensitivity 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Infections and infestations
    Incision site infection 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Pneumonia 1/4 (25%) 1 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 2/9 (22.2%) 2 0/3 (0%) 0 0/14 (0%) 0
    Sinusitis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Skin infection 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Upper respiratory tract infection 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 2 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Urinary tract infection 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 1/12 (8.3%) 1 0/6 (0%) 0 1/6 (16.7%) 4 1/7 (14.3%) 1 1/9 (11.1%) 1 0/3 (0%) 0 2/14 (14.3%) 2
    Wound infection 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Bronchopulmonary aspergillosis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Cellulitis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Clostridium difficile colitis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Furuncle 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Klebsiella bacteraemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Oral candidiasis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Oral herpes 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Pneumonia bacterial 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Pneumonia fungal 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Rash pustular 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Rhinovirus infection 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Staphylococcal infection 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Tinea pedis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Injury, poisoning and procedural complications
    Animal scratch 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Arthropod bite 0/4 (0%) 0 1/11 (9.1%) 2 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Fall 1/4 (25%) 1 0/11 (0%) 0 1/4 (25%) 2 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 2/14 (14.3%) 2
    Infusion related reaction 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 3 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Rib fracture 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Transfusion reaction 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Vascular access complication 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Contusion 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 2/14 (14.3%) 2
    Foot fracture 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Head injury 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Post procedural haematoma 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Post procedural swelling 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Procedural pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Investigations
    Alanine aminotransferase increased 2/4 (50%) 2 2/11 (18.2%) 2 1/4 (25%) 2 8/21 (38.1%) 10 4/12 (33.3%) 5 2/6 (33.3%) 2 4/6 (66.7%) 4 1/7 (14.3%) 1 4/9 (44.4%) 8 0/3 (0%) 0 6/14 (42.9%) 7
    Aspartate aminotransferase increased 2/4 (50%) 2 2/11 (18.2%) 3 1/4 (25%) 2 7/21 (33.3%) 9 4/12 (33.3%) 5 1/6 (16.7%) 1 3/6 (50%) 3 0/7 (0%) 0 4/9 (44.4%) 6 0/3 (0%) 0 6/14 (42.9%) 8
    Blood alkaline phosphatase increased 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 4/21 (19%) 4 4/12 (33.3%) 5 2/6 (33.3%) 3 1/6 (16.7%) 1 0/7 (0%) 0 2/9 (22.2%) 2 0/3 (0%) 0 1/14 (7.1%) 1
    Blood bilirubin increased 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 2/21 (9.5%) 2 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 4/9 (44.4%) 6 0/3 (0%) 0 1/14 (7.1%) 1
    Blood creatinine increased 1/4 (25%) 1 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Neutrophil count decreased 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 2 0/7 (0%) 0 2/9 (22.2%) 4 0/3 (0%) 0 1/14 (7.1%) 1
    Platelet count decreased 1/4 (25%) 1 0/11 (0%) 0 1/4 (25%) 1 1/21 (4.8%) 1 2/12 (16.7%) 3 0/6 (0%) 0 2/6 (33.3%) 3 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 4/14 (28.6%) 6
    Weight decreased 1/4 (25%) 1 1/11 (9.1%) 1 1/4 (25%) 1 1/21 (4.8%) 1 2/12 (16.7%) 2 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 2/9 (22.2%) 2 0/3 (0%) 0 0/14 (0%) 0
    White blood cell count decreased 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 1/12 (8.3%) 1 1/6 (16.7%) 1 1/6 (16.7%) 1 1/7 (14.3%) 1 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    White blood cell count increased 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 2/21 (9.5%) 2 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 2 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Activated partial thromboplastin time prolonged 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/9 (22.2%) 2 0/3 (0%) 0 0/14 (0%) 0
    Aspartate aminotransferase 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Bilirubin conjugated increased 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Blood cholesterol increased 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Electrocardiogram QT prolonged 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 2/7 (28.6%) 2 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    International normalised ratio increased 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Lymphocyte count decreased 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 3 0/3 (0%) 0 0/14 (0%) 0
    Troponin T increased 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 2/4 (50%) 2 2/11 (18.2%) 2 2/4 (50%) 2 3/21 (14.3%) 3 3/12 (25%) 3 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 4/9 (44.4%) 4 1/3 (33.3%) 1 0/14 (0%) 0
    Dehydration 0/4 (0%) 0 1/11 (9.1%) 1 1/4 (25%) 1 1/21 (4.8%) 1 3/12 (25%) 3 1/6 (16.7%) 1 2/6 (33.3%) 3 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Gout 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Hypercalcaemia 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Hyperglycaemia 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 2/9 (22.2%) 9 0/3 (0%) 0 3/14 (21.4%) 3
    Hyperphosphataemia 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Hyperuricaemia 1/4 (25%) 1 1/11 (9.1%) 1 0/4 (0%) 0 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 1/9 (11.1%) 1 0/3 (0%) 0 2/14 (14.3%) 2
    Hypokalaemia 0/4 (0%) 0 2/11 (18.2%) 2 0/4 (0%) 0 3/21 (14.3%) 3 1/12 (8.3%) 1 0/6 (0%) 0 3/6 (50%) 4 1/7 (14.3%) 2 2/9 (22.2%) 3 0/3 (0%) 0 2/14 (14.3%) 2
    Hypomagnesaemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 1/12 (8.3%) 1 0/6 (0%) 0 1/6 (16.7%) 3 2/7 (28.6%) 2 1/9 (11.1%) 2 0/3 (0%) 0 1/14 (7.1%) 1
    Hyponatraemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 2/21 (9.5%) 2 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 2/7 (28.6%) 2 2/9 (22.2%) 2 0/3 (0%) 0 0/14 (0%) 0
    Hypophosphataemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 2/21 (9.5%) 2 0/12 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2 1/7 (14.3%) 1 2/9 (22.2%) 2 0/3 (0%) 0 0/14 (0%) 0
    Hypovolaemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Increased appetite 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Lactic acidosis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Metabolic alkalosis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Failure to thrive 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Hyperkalaemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 4 0/3 (0%) 0 1/14 (7.1%) 1
    Hypermagnesaemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 2/14 (14.3%) 2
    Hypernatraemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Hypertriglyceridaemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Hypoalbuminaemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/9 (22.2%) 2 0/3 (0%) 0 1/14 (7.1%) 1
    Hypocalcaemia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Iron overload 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 2/14 (14.3%) 2
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/4 (0%) 0 1/11 (9.1%) 1 2/4 (50%) 2 2/21 (9.5%) 2 1/12 (8.3%) 1 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 2/9 (22.2%) 3 0/3 (0%) 0 2/14 (14.3%) 3
    Back pain 0/4 (0%) 0 2/11 (18.2%) 3 0/4 (0%) 0 1/21 (4.8%) 1 1/12 (8.3%) 1 0/6 (0%) 0 1/6 (16.7%) 1 1/7 (14.3%) 1 3/9 (33.3%) 3 0/3 (0%) 0 1/14 (7.1%) 1
    Flank pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Muscle spasms 0/4 (0%) 0 1/11 (9.1%) 1 1/4 (25%) 1 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 2/14 (14.3%) 2
    Musculoskeletal chest pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Musculoskeletal pain 0/4 (0%) 0 2/11 (18.2%) 2 1/4 (25%) 1 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Myalgia 1/4 (25%) 1 0/11 (0%) 0 1/4 (25%) 1 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Pain in extremity 0/4 (0%) 0 1/11 (9.1%) 1 1/4 (25%) 1 0/21 (0%) 0 1/12 (8.3%) 1 1/6 (16.7%) 1 2/6 (33.3%) 3 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Pain in jaw 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Arthritis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Bone pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Gouty tophus 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Muscular weakness 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 4/14 (28.6%) 4
    Neck pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma of skin 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Nervous system disorders
    Cerebrovascular accident 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Dizziness 0/4 (0%) 0 1/11 (9.1%) 1 1/4 (25%) 1 1/21 (4.8%) 1 2/12 (16.7%) 2 2/6 (33.3%) 2 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 1/3 (33.3%) 1 0/14 (0%) 0
    Dysgeusia 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 3/9 (33.3%) 3 0/3 (0%) 0 1/14 (7.1%) 1
    Headache 1/4 (25%) 1 0/11 (0%) 0 1/4 (25%) 3 2/21 (9.5%) 2 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 2/9 (22.2%) 2 0/3 (0%) 0 0/14 (0%) 0
    Neuropathy peripheral 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Peripheral sensory neuropathy 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 2/14 (14.3%) 2
    Somnolence 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Syncope 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Transient ischaemic attack 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Cerebellar haemorrhage 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Dysarthria 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Haemorrhage intracranial 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Hypoaesthesia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Memory impairment 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Paraesthesia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Parosmia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Tongue paralysis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Tremor 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Psychiatric disorders
    Agitation 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Anxiety 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Confusional state 1/4 (25%) 1 1/11 (9.1%) 1 1/4 (25%) 1 0/21 (0%) 0 2/12 (16.7%) 2 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Delirium 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Insomnia 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 2/12 (16.7%) 2 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Irritability 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Libido decreased 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Psychotic disorder 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Depression 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Renal and urinary disorders
    Acute kidney injury 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 2/21 (9.5%) 2 1/12 (8.3%) 1 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 2/9 (22.2%) 2 0/3 (0%) 0 0/14 (0%) 0
    Dysuria 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Pollakiuria 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Urinary tract pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Haematuria 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Proteinuria 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Urinary retention 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2 0/7 (0%) 0 2/9 (22.2%) 2 0/3 (0%) 0 0/14 (0%) 0
    Reproductive system and breast disorders
    Breast cyst 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Pelvic pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Respiratory, thoracic and mediastinal disorders
    Cough 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 3/21 (14.3%) 3 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/9 (22.2%) 4 1/3 (33.3%) 1 1/14 (7.1%) 1
    Dyspnoea 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 2/21 (9.5%) 2 4/12 (33.3%) 4 1/6 (16.7%) 1 2/6 (33.3%) 3 1/7 (14.3%) 1 1/9 (11.1%) 1 0/3 (0%) 0 2/14 (14.3%) 2
    Dyspnoea exertional 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Epistaxis 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 2 1/6 (16.7%) 1 0/7 (0%) 0 2/9 (22.2%) 2 0/3 (0%) 0 0/14 (0%) 0
    Haemoptysis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 2/12 (16.7%) 2 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Hypoxia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/9 (22.2%) 2 0/3 (0%) 0 0/14 (0%) 0
    Nasal congestion 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Oropharyngeal pain 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 4/21 (19%) 4 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Pleural effusion 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 2/12 (16.7%) 2 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Pleuritic pain 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Pulmonary embolism 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Rhinitis allergic 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 1/21 (4.8%) 1 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Rhinorrhoea 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Wheezing 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Productive cough 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Pulmonary oedema 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Upper-airway cough syndrome 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Skin and subcutaneous tissue disorders
    Acute febrile neutrophilic dermatosis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Night sweats 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Petechiae 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0 2/7 (28.6%) 2 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Rash 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 1/12 (8.3%) 1 2/6 (33.3%) 2 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Rash maculo-papular 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 3 2/7 (28.6%) 2 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Skin mass 1/4 (25%) 1 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Alopecia 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Blood blister 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Ecchymosis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0
    Erythema 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Hyperhidrosis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Onychoclasis 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Pruritus 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 1/14 (7.1%) 1
    Pruritus allergic 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Skin exfoliation 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Skin lesion 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/7 (14.3%) 1 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Skin tightness 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Surgical and medical procedures
    Skin neoplasm excision 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 2
    Vascular disorders
    Deep vein thrombosis 0/4 (0%) 0 0/11 (0%) 0 1/4 (25%) 1 1/21 (4.8%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Orthostatic hypotension 0/4 (0%) 0 1/11 (9.1%) 1 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 0/14 (0%) 0
    Flushing 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 0/9 (0%) 0 0/3 (0%) 0 1/14 (7.1%) 1
    Haematoma 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 2/9 (22.2%) 3 0/3 (0%) 0 0/14 (0%) 0
    Hypertension 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 3 0/3 (0%) 0 0/14 (0%) 0
    Hypotension 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 3 1/7 (14.3%) 1 2/9 (22.2%) 2 0/3 (0%) 0 0/14 (0%) 0
    Pallor 0/4 (0%) 0 0/11 (0%) 0 0/4 (0%) 0 0/21 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/7 (0%) 0 1/9 (11.1%) 1 0/3 (0%) 0 0/14 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    Clinical Study Agreement

    Results Point of Contact

    Name/Title Incyte Corporation
    Organization Call Center
    Phone 1-855-463-3463
    Email medinfo@incyte.com
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT02587598
    Other Study ID Numbers:
    • INCB 53914-101
    First Posted:
    Oct 27, 2015
    Last Update Posted:
    Dec 8, 2021
    Last Verified:
    Nov 1, 2021