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An Open-Label Study of a Novel JAK-inhibitor, INCB052793, Given to Patients With Advanced Malignancies

Sponsor
Incyte Corporation (Industry)
Overall Status
Terminated
CT.gov ID
NCT02265510
Collaborator
(none)
83
Enrollment
14
Locations
3
Arms
53.6
Actual Duration (Months)
5.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This was a study of INCB052793 given to patients with advanced malignancies that was to be conducted in three phases; Phase 1a (Monotherapy) and Phase 1b (Combination Therapy) and Phase 2 (Combination therapy of INCB052793 with azacitidine and itacitinib with azacitidine). Phase 1 had two parts; a dose escalation (Part 1) and an expansion (Part 2).

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

Study Design

Study Type:
Interventional
Actual Enrollment :
83 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB052793 in Subjects With Advanced Malignancies
Actual Study Start Date :
Sep 10, 2014
Actual Primary Completion Date :
Feb 27, 2019
Actual Study Completion Date :
Feb 27, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase 1a: INCB052793 Monotherapy

Drug: INCB052793
Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
Experimental: Phase 1b: INCB052793 Combination Therapy

Drug: gemcitabine
Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency.
Other Names:
  • Gemzar®

    • Drug: nab-paclitaxel
    nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.
    Other Names:
  • Abraxane®

    • Drug: dexamethasone
    Dexamethasone administered orally at the protocol-specified dose and frequency.

    Drug: Carfilzomib
    Carfilzomib administered intravenously at the protocol-specified dose and frequency.
    Other Names:
  • Kyprolis®

    • Drug: bortezomib
    Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.
    Other Names:
  • Velcade®

    • Drug: lenalidomide
    Lenalidomide administered orally at the protocol-specified dose and frequency.
    Other Names:
  • Revlimid®

    • Drug: azacitidine
    Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
    Other Names:
  • Vidaza®

    • Drug: INCB052793
    INCB052793 tablets administered orally at the protocol specified dose strength and frequency.

    Drug: pomalidomide
    Pomalidomide administered orally at the protocol-specified dose and frequency.
    Other Names:
  • Pomalyst®

    • Drug: INCB050465
    INCB050465 tablets administered orally at the protocol specified dose strength and frequency.
    Experimental: Phase 2: INCB052793 and itacitinib Combination Therapy

    Drug: azacitidine
    Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
    Other Names:
  • Vidaza®

    • Drug: INCB052793
    INCB052793 tablets administered orally at the protocol specified dose strength and frequency.

    Drug: INCB039110
    INCB039110 tablets administered orally at the protocol specified dose strength and frequency.
    Other Names:
  • itacitinib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) [From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)]

      An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.

    2. Phase 2: Objective Response Rate (ORR) in Hematological Malignancies [Baseline through end of study (Up to approximately 4.5 years)]

      ORR is defined as the proportion of participants who achieved complete response (CR), CR with incomplete hematologic recovery (CRi), partial response (PR), or hematologic improvement (HI), using the IWG response criteria.

    Secondary Outcome Measures

    1. Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment [Baseline through end of study (Up to approximately 4.5 years)]

      Response rate is defined as the percentage of participants who achieved best overall response (BOR) as determined by IWG response criteria of investigator's assessment. A participant was considered an objective responder based on the following- Solid tumors: participant had a best overall response (BOR) of CR or PR, Lymphoma: participant had a BOR of complete radiologic response/complete metabolic response or partial remission/partial metabolic response, AML: participant had a BOR of CR, CRi, morphological leukemia-free state (MLFS), or PR, MDS: participant had a BOR of CR, PR, or marrow CR, MDS/myeloproliferative neoplasm (MPN): participant had a BOR of CR, PR, or marrow response, MM: participant had a BOR of stringent CR, CR, very good PR, PR, or MR. Subjects are combined by tumor type for this analysis.

    2. Phase 2: Number of Participants With at Least One TEAE and SAE [From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 1.3 years)]

      An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.

    3. Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 [Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2]

      Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.

    4. Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 [Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2]

      Tmax is the time to maximum (peak) observed plasma drug concentration. Summary of Steady-State, Day 15, was evaluated by dosing regimen. For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.

    5. Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 [Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2]

      AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.

    6. Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration of Itacitinib [Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2]

      Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).

    7. Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for Itacitinib [Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2]

      Tmax is the time to maximum (peak) observed plasma drug concentration.

    8. Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for Itacitinib [Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2]

      AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).

    9. Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 [Cycle 1, Day 1]

      Cmax is defined as the maximum observed plasma concentration measured at Day 1.

    10. Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 [Cycle 1, Day 1]

      Tmax is the time to maximum (peak) observed plasma drug concentration.

    11. Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time t [Cycle 1, Day 1]

      AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.

    12. Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 [Cycle 1, Day 15]

      Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).

    13. Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval [Cycle 1, Day 15]

      Minimum observed plasma concentration measured at steady state (Day 15).

    14. Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 [Cycle 1, Day 15]

      Tmax is the time to maximum (peak) observed plasma drug concentration.

    15. Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time [Cycle 1, Day 15]

      AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).

    16. Phase 1a, Part 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 [Cycle 1, Day 15]

      AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.

    17. Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793 [Cycle 2, Day 1]

      Cmax is defined as the maximum observed plasma concentration measured at cycle 2 Day 1.

    18. Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval [Cycle 2, Day 1]

      Cmin is defined as the minimal observed plasma concentration measured at cycle 2 Day 1

    19. Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793 [Cycle 2, Day 1]

      Tmax is the time to maximum (peak) observed plasma drug concentration.

    20. Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time [Cycle 2, Day 1]

      AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.

    21. Phase 1a, Part 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793 [Cycle 2, Day 1]

      AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.

    Eligibility Criteria

    Criteria

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

    Phase 1a

    • Aged 18 years or older

    • Histologically or cytologically confirmed solid tumor or hematologic malignancy

    • Life expectancy of 12 weeks or longer

    • Must have received ≥ 1 prior treatment regimen

    • Must not be a candidate for potentially curative or standard of care approved therapy

    Phase 1b

    • Aged 18 years or older

    • Cohort A: Histologically or cytologically confirmed pancreatic adenocarcinoma, triple-negative breast cancer, urothelial cancer with at least 1 measurable or evaluable target lesion

    • Cohorts B, C, D, E and G: Histologically confirmed multiple myeloma and measureable/evaluable disease

    • Cohort F: Confirmed acute myeloid leukemia or myelodysplastic syndrome

    • Cohort H: Individuals diagnosed with lymphoma

    • Prior therapy:

    • Cohort A: No more than 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy)

    • Cohorts B, C, D, E and G: Must have relapsed from or have been refractory to ≥ 2 prior treatment regimens

    • Cohort F: May have received any number of prior treatment regimens or be treatment-naïve

    • Cohort H: Must have relapsed from or have been refractory to available treatments

    Phase 2

    • Aged 18 years or older

    • Cohorts I and J: Confirmed acute myeloid leukemia or high risk myelodysplastic syndrome

    • Prior therapy:

    • Cohorts I and J: Must have failed prior therapy with a hypomethylating agent (HMA)

    Exclusion Criteria:

    • Prior receipt of a JAK1 inhibitor (Phase 1a only)

    • Known active central nervous system metastases and/or carcinomatous meningitis

    • Eastern Cooperative Oncology Group (ECOG) performance status > 2

    • Any known contraindications to the use of gemcitabine, nab-paclitaxel, dexamethasone, carfilzomib, bortezomib, lenalidomide, azacitidine, pomalidomide or PI3Kδ inhibitor (Phase 1b and Phase 2 only, as appropriate to treatment cohort)

    • Known human immunodeficiency virus infection, or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States
    2 West Hollywood California United States
    3 New Haven Connecticut United States
    4 Atlanta Georgia United States
    5 Chicago Illinois United States
    6 Indianapolis Indiana United States
    7 Hackensack New Jersey United States
    8 New York New York United States
    9 Durham North Carolina United States
    10 Portland Oregon United States
    11 Greenville South Carolina United States
    12 Site 2 Nashville Tennessee United States
    13 Nashville Tennessee United States
    14 Dallas Texas United States

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    • Study Director: Ekaterine Asatiani, M.D., Incyte Corporation

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT02265510
    Other Study ID Numbers:
    • INCB 52793-101
    First Posted:
    Oct 16, 2014
    Last Update Posted:
    Apr 17, 2020
    Last Verified:
    Apr 1, 2020
    Additional relevant MeSH terms:
    Neoplasms
    Gemcitabine
    Dexamethasone
    Paclitaxel
    Lenalidomide
    Bortezomib
    Azacitidine
    Pomalidomide

    Study Results

    Participant Flow

    Recruitment Details Participants took part in the study at 11 investigative sites in United States from 10 September 2014 to 27 February 2019. This study was prematurely terminated due to lack of efficacy.
    Pre-assignment Detail Participants with advanced malignancies,acute myeloid leukemia(AML),high-risk myelodysplastic syndrome(MDS)who failed prior therapy with hypomethylating agents(HMA)enrolled to dose escalation(Part 1),expansion(Part 2) of INCB052793 monotherapy and combination therapy cohorts.CohortsA,C,D,E,G,H had no enrollment at the time of premature termination.
    Arm/Group Title Phase 1a TGA - INCB052793 15 mg Phase 1a TGA - INCB052793 25 mg Phase 1a TGA - INCB052793 35 mg Phase 1a TGA - INCB052793 50 mg Phase 1a TGA - INCB052793 75 mg Phase 1a TGA - INCB052793 100 mg Phase 1a TGB - INCB052793 25 mg Phase 1a TGB - INCB052793 35 mg Phase 1a TGB - INCB052793 50 mg Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 Hase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
    Arm/Group Description INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria. INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21day cycles until they met treatment discontinuation criteria. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle. INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
    Period Title: Overall Study
    STARTED 3 3 6 4 3 6 3 4 4 7 5 16 9 10
    COMPLETED 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    NOT COMPLETED 3 3 6 4 3 6 3 4 4 7 5 16 9 10

    Baseline Characteristics

    Arm/Group Title Phase 1a TGA - INCB052793 15 mg Phase 1a TGA - INCB052793 25 mg Phase 1a TGA - INCB052793 35 mg Phase 1a TGA - INCB052793 50 mg Phase 1a TGA - INCB052793 75 mg Phase 1a TGA - INCB052793 100 mg Phase 1a TGB - INCB052793 25 mg Phase 1a TGB - INCB052793 35 mg Phase 1a TGB - INCB052793 50 mg Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2 • Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2 Total
    Arm/Group Description INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle Total of all reporting groups
    Overall Participants 3 3 6 4 3 6 3 4 4 7 5 16 9 10 83
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    63.7
    (8.08)
    59.0
    (9.85)
    57.0
    (13.19)
    54.5
    (13.40)
    46.0
    (15.13)
    63.0
    (10.77)
    60.3
    (6.66)
    58.5
    (6.45)
    56.3
    (3.69)
    60.3
    (13.84)
    62.8
    (14.17)
    64.4
    (15.47)
    70.4
    (5.64)
    71.2
    (8.50)
    62.6
    (12.31)
    Sex: Female, Male (Count of Participants)
    Female
    1
    33.3%
    2
    66.7%
    2
    33.3%
    2
    50%
    2
    66.7%
    4
    66.7%
    1
    33.3%
    0
    0%
    1
    25%
    0
    0%
    3
    60%
    7
    43.8%
    2
    22.2%
    2
    20%
    29
    34.9%
    Male
    2
    66.7%
    1
    33.3%
    4
    66.7%
    2
    50%
    1
    33.3%
    2
    33.3%
    2
    66.7%
    4
    100%
    3
    75%
    7
    100%
    2
    40%
    9
    56.3%
    7
    77.8%
    8
    80%
    54
    65.1%
    Race/Ethnicity, Customized (Count of Participants)
    White/Caucasian
    3
    100%
    3
    100%
    5
    83.3%
    2
    50%
    2
    66.7%
    5
    83.3%
    2
    66.7%
    3
    75%
    4
    100%
    5
    71.4%
    5
    100%
    14
    87.5%
    9
    100%
    8
    80%
    70
    84.3%
    Black/African-American
    0
    0%
    0
    0%
    1
    16.7%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    1
    14.3%
    0
    0%
    2
    12.5%
    0
    0%
    2
    20%
    8
    9.6%
    American-Indian/Alaska Native
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1.2%
    Other
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    1
    16.7%
    1
    33.3%
    0
    0%
    0
    0%
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    4
    4.8%
    Missing
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    1
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    1
    14.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3
    3.6%
    Not Hispanic or Latino
    2
    66.7%
    3
    100%
    6
    100%
    4
    100%
    2
    66.7%
    6
    100%
    2
    66.7%
    3
    75%
    4
    100%
    6
    85.7%
    5
    100%
    16
    100%
    9
    100%
    10
    100%
    78
    94%
    Unknown
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    33.3%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2
    2.4%

    Outcome Measures

    1. Primary Outcome
    Title Phase 1a and 1b: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
    Description An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.
    Time Frame From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 3.4 years)

    Outcome Measure Data

    Analysis Population Description
    Safety evaluable population included all participants exposed to ≥ 1 dose of study drug.
    Arm/Group Title Phase 1a TGA - INCB052793 15 mg Phase 1a TGA - INCB052793 25 mg Phase 1a TGA - INCB052793 35 mg Phase 1a TGA - INCB052793 50 mg Phase 1a TGA - INCB052793 75 mg Phase 1a TGA - INCB052793 100 mg Phase 1a TGB - INCB052793 25 mg Phase 1a TGB - INCB052793 35 mg Phase 1a TGB - INCB052793 50 mg Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
    Arm/Group Description INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle
    Measure Participants 3 3 6 4 3 6 3 4 4 7 5 16
    TEAE
    3
    100%
    3
    100%
    6
    100%
    4
    100%
    3
    100%
    6
    100%
    3
    100%
    4
    100%
    4
    100%
    7
    100%
    5
    100%
    16
    100%
    SAE
    0
    0%
    1
    33.3%
    0
    0%
    2
    50%
    3
    100%
    2
    33.3%
    1
    33.3%
    2
    50%
    2
    50%
    5
    71.4%
    4
    80%
    14
    87.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Phase 1a TGA - INCB052793 15 mg, Phase 1a TGA - INCB052793 25 mg, Phase 1a TGA - INCB052793 35 mg, Phase 1a TGA - INCB052793 50 mg, Phase 1a TGA - INCB052793 75 mg, Phase 1a TGA - INCB052793 100 mg, Phase 1a TGB - INCB052793 25 mg, Phase 1a TGB - INCB052793 35 mg, Phase 1a TGB - INCB052793 50 mg, Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg, Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2, Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2
    Comments
    Type of Statistical Test Other
    Comments Descriptive Statistics
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Other Statistical Analysis The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    2. Primary Outcome
    Title Phase 2: Objective Response Rate (ORR) in Hematological Malignancies
    Description ORR is defined as the proportion of participants who achieved complete response (CR), CR with incomplete hematologic recovery (CRi), partial response (PR), or hematologic improvement (HI), using the IWG response criteria.
    Time Frame Baseline through end of study (Up to approximately 4.5 years)

    Outcome Measure Data

    Analysis Population Description
    Efficacy evaluable population included all participants exposed to ≥ 1 dose of study drug.
    Arm/Group Title Phase 2 Cohort I-INCB052793 +Azacytidine (AML) Phase 2 Cohort I-INCB052793 +Azacytidine (MDS) Phase 2 Cohort J-Itacitinib +Azacitidine (AML) Phase 2 Cohort J-Itacitinib +Azacitidine (MDS)
    Arm/Group Description INCB052793 35 mg tablet, PO, QD in the fasted state in participants with HMA-refractory AML in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. INCB052793 35 mg tablet, PO, QD in the fasted state in participants with high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle .
    Measure Participants 6 3 8 2
    Count of Participants [Participants]
    0
    0%
    1
    33.3%
    1
    16.7%
    0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Phase 1a TGA - INCB052793 15 mg, Phase 1a TGA - INCB052793 25 mg, Phase 1a TGA - INCB052793 35 mg, Phase 1a TGA - INCB052793 50 mg
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Other Statistical Analysis Confidence Intervals for ORR were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.
    3. Secondary Outcome
    Title Phase 1A and 1B: Percentage of Participants With Response as Determined by Investigator's Assessment
    Description Response rate is defined as the percentage of participants who achieved best overall response (BOR) as determined by IWG response criteria of investigator's assessment. A participant was considered an objective responder based on the following- Solid tumors: participant had a best overall response (BOR) of CR or PR, Lymphoma: participant had a BOR of complete radiologic response/complete metabolic response or partial remission/partial metabolic response, AML: participant had a BOR of CR, CRi, morphological leukemia-free state (MLFS), or PR, MDS: participant had a BOR of CR, PR, or marrow CR, MDS/myeloproliferative neoplasm (MPN): participant had a BOR of CR, PR, or marrow response, MM: participant had a BOR of stringent CR, CR, very good PR, PR, or MR. Subjects are combined by tumor type for this analysis.
    Time Frame Baseline through end of study (Up to approximately 4.5 years)

    Outcome Measure Data

    Analysis Population Description
    Efficacy evaluable population included all participants exposed to ≥ 1 dose of study drug.
    Arm/Group Title Phase 1a TGA - INCB052793 in Solid Tumors Phase 1a TGB - INCB052793 in Lymphoma Phase 1a TGB - INCB052793 in MDS/MPN Phase 1a TGB - INCB052793 in MM Phase 1b Cohort B - INCB052793 + Dexamethasone in MM Phase 1b Cohort F-INCB052793 +Azacytidine in AML Phase 1b Cohort F-INCB052793 +Azacytidine in MDS Phase 1b Cohort F-INCB052793 +Azacytidine in MDS/MPN
    Arm/Group Description INCB052793 tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
    Measure Participants 25 4 4 3 7 12 7 2
    Count of Participants [Participants]
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    2
    66.7%
    4
    66.7%
    3
    100%
    2
    50%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Phase 1a TGA - INCB052793 15 mg, Phase 1a TGA - INCB052793 25 mg, Phase 1a TGA - INCB052793 35 mg, Phase 1a TGA - INCB052793 50 mg, Phase 1a TGA - INCB052793 75 mg, Phase 1a TGA - INCB052793 100 mg, Phase 1a TGB - INCB052793 25 mg, Phase 1a TGB - INCB052793 35 mg
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Other Statistical Analysis Confidence Intervals for response were calculated based on the exact method for binomial distributions. There were no comparison between treatment groups.
    4. Secondary Outcome
    Title Phase 2: Number of Participants With at Least One TEAE and SAE
    Description An AE is any untoward medical occurrence in a subject administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. A TEAE was defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last dose of study drug.
    Time Frame From first dose of study drug up to 30 days after last dose of study drug (Up to approximately 1.3 years)

    Outcome Measure Data

    Analysis Population Description
    Safety evaluable population included all participants exposed to ≥ 1 dose of study drug.
    Arm/Group Title Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
    Arm/Group Description INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
    Measure Participants 9 10
    TEAE
    9
    300%
    10
    333.3%
    SAE
    7
    233.3%
    8
    266.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Phase 1a TGA - INCB052793 15 mg, Phase 1a TGA - INCB052793 25 mg
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Other Statistical Analysis The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
    5. Secondary Outcome
    Title Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
    Description Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
    Time Frame Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

    Outcome Measure Data

    Analysis Population Description
    The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
    Arm/Group Title Phase 1a TGA - INCB052793 15 mg Phase 1a TGA - INCB052793 25 mg Phase 1a TGA - INCB052793 35 mg Phase 1a TGA - INCB052793 50 mg Phase 1a TGA - INCB052793 75 mg Phase 1a TGA - INCB052793 100 mg Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2
    Arm/Group Description INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 78.3 days ). INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 96.3 days). INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 80.3 days). INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 46.5 days). INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 459.0 days). INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 44.0 days). INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
    Measure Participants 3 6 7 7 3 3 6 6 15 8
    Mean (Standard Deviation) [nM]
    522
    (126)
    1110
    (324)
    1120
    (543)
    2050
    (1070)
    1840
    (563)
    2890
    (1690)
    928
    (263)
    1270
    (856)
    1480
    (588)
    1610
    (745)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Phase 1a TGA - INCB052793 15 mg, Phase 1a TGA - INCB052793 25 mg, Phase 1a TGA - INCB052793 35 mg, Phase 1a TGA - INCB052793 50 mg, Phase 1a TGA - INCB052793 75 mg, Phase 1a TGA - INCB052793 100 mg, Phase 1a TGB - INCB052793 25 mg, Phase 1a TGB - INCB052793 35 mg, Phase 1a TGB - INCB052793 50 mg, Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Other Statistical Analysis The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
    6. Secondary Outcome
    Title Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
    Description Tmax is the time to maximum (peak) observed plasma drug concentration. Summary of Steady-State, Day 15, was evaluated by dosing regimen. For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
    Time Frame Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

    Outcome Measure Data

    Analysis Population Description
    The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
    Arm/Group Title Phase 1a TGA - INCB052793 15 mg Phase 1a TGA - INCB052793 25 mg Phase 1a TGA - INCB052793 35 mg Phase 1a TGA - INCB052793 50 mg Phase 1a TGA - INCB052793 75 mg Phase 1a TGA - INCB052793 100 mg Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2
    Arm/Group Description INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 78.3 days ). INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 96.3 days). INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 80.3 days). INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 46.5 days). INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 459.0 days). INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 44.0 days). INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle. INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
    Measure Participants 3 6 7 7 3 3 6 6 15 8
    Median (Full Range) [hours (hr)]
    1.1
    0.76
    2.0
    1.1
    2.2
    2.0
    1.0
    1.1
    1.1
    0.51
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Phase 1a TGA - INCB052793 15 mg, Phase 1a TGA - INCB052793 25 mg, Phase 1a TGA - INCB052793 35 mg, Phase 1a TGA - INCB052793 50 mg, Phase 1a TGA - INCB052793 75 mg, Phase 1a TGA - INCB052793 100 mg, Phase 1a TGB - INCB052793 25 mg, Phase 1a TGB - INCB052793 35 mg, Phase 1a TGB - INCB052793 50 mg, Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Other Statistical Analysis The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
    7. Secondary Outcome
    Title Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
    Description AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15). For PK analyses subjects in TGA and TGB are combined by dosage group because only 3 subjects were enrolled in each dose group in TGB and 4 subject for first dose in TGB 50 mg.
    Time Frame Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

    Outcome Measure Data

    Analysis Population Description
    The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
    Arm/Group Title Phase 1a TGA - INCB052793 15 mg Phase 1a TGA - INCB052793 25 mg Phase 1a TGA - INCB052793 35 mg Phase 1a TGA - INCB052793 50 mg Phase 1a TGA - INCB052793 75 mg Phase 1a TGA - INCB052793 100 mg Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2
    Arm/Group Description INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 78.3 days ). INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 96.3 days). INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 80.3 days). INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 46.5 days). INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 459.0 days). INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 44.0 days). INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 21-day cycle . INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle. INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle .
    Measure Participants 3 6 7 7 3 3 6 6 15 8
    Mean (Standard Deviation) [nM*hr]
    4750
    (1380)
    9170
    (4290)
    8430
    (2520)
    14700
    (6670)
    18300
    (10600)
    27800
    (12300)
    6390
    (1690)
    9580
    (6710)
    10200
    (5260)
    9380
    (4390)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Phase 1a TGA - INCB052793 15 mg, Phase 1a TGA - INCB052793 25 mg, Phase 1a TGA - INCB052793 35 mg, Phase 1a TGA - INCB052793 50 mg, Phase 1a TGA - INCB052793 75 mg, Phase 1a TGA - INCB052793 100 mg, Phase 1a TGB - INCB052793 25 mg, Phase 1a TGB - INCB052793 35 mg, Phase 1a TGB - INCB052793 50 mg, Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Other Statistical Analysis The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
    8. Secondary Outcome
    Title Phase 1a, 1b, and Phase 2: Cmax: Maximum Observed Plasma Concentration of Itacitinib
    Description Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).
    Time Frame Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

    Outcome Measure Data

    Analysis Population Description
    The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
    Arm/Group Title Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
    Arm/Group Description Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
    Measure Participants 9
    Mean (Standard Deviation) [nM]
    1310
    (638)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Phase 1a TGA - INCB052793 15 mg
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Other Statistical Analysis The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
    9. Secondary Outcome
    Title Phase 1a, 1b, and Phase 2: Tmax: Time to Maximum Plasma Concentration for Itacitinib
    Description Tmax is the time to maximum (peak) observed plasma drug concentration.
    Time Frame Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

    Outcome Measure Data

    Analysis Population Description
    The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
    Arm/Group Title Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
    Arm/Group Description Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
    Measure Participants 9
    Median (Full Range) [hr]
    3.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Phase 1a TGA - INCB052793 15 mg
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Other Statistical Analysis The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
    10. Secondary Outcome
    Title Phase 1a, 1b, and Phase 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for Itacitinib
    Description AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).
    Time Frame Cycle 1, Day 15: predose and 0.5, 1, 2, 4, 6 hours postdose in Phase 1a; 0 (predose), 0.08, 0.5, 1, 2, 4, 6 and 8 hours postdose in Phase 1b and Phase 2

    Outcome Measure Data

    Analysis Population Description
    The PK evaluable population includes all subjects who received at least 1 dose of study treatment and provided serial samples for PK analysis
    Arm/Group Title Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
    Arm/Group Description Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 21-day cycle.
    Measure Participants 9
    Mean (Standard Deviation) [nM*hr]
    9870
    (7350)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Phase 1a TGA - INCB052793 15 mg
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Other Statistical Analysis The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
    11. Secondary Outcome
    Title Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
    Description Cmax is defined as the maximum observed plasma concentration measured at Day 1.
    Time Frame Cycle 1, Day 1

    Outcome Measure Data

    Analysis Population Description
    Data was not collected as no participants were enrolled in Part 2 of the study.
    Arm/Group Title Phase 1a Part 2 Expasion Cohort- INCB052793
    Arm/Group Description INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
    Measure Participants 0
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Phase 1a TGA - INCB052793 15 mg
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Other Statistical Analysis The analysis of the endpoint was descriptive i.e. no statistical hypothesis test was performed.
    12. Secondary Outcome
    Title Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
    Description Tmax is the time to maximum (peak) observed plasma drug concentration.
    Time Frame Cycle 1, Day 1

    Outcome Measure Data

    Analysis Population Description
    Data was not collected as no participants were enrolled in Part 2 of the study
    Arm/Group Title Phase 1a Part 2 Expasion Cohort- INCB052793
    Arm/Group Description INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
    Measure Participants 0
    13. Secondary Outcome
    Title Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time t
    Description AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
    Time Frame Cycle 1, Day 1

    Outcome Measure Data

    Analysis Population Description
    Data was not collected as no participants were enrolled in Part 2 of the study
    Arm/Group Title Phase 1a Part 2 Expasion Cohort- INCB052793
    Arm/Group Description INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
    Measure Participants 0
    14. Secondary Outcome
    Title Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
    Description Cmax is defined as the maximum observed plasma concentration measured at steady state (Day 15).
    Time Frame Cycle 1, Day 15

    Outcome Measure Data

    Analysis Population Description
    Data was not collected as no participants were enrolled in Part 2 of the study
    Arm/Group Title Phase 1a Part 2 Expasion Cohort- INCB052793
    Arm/Group Description INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
    Measure Participants 0
    15. Secondary Outcome
    Title Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval
    Description Minimum observed plasma concentration measured at steady state (Day 15).
    Time Frame Cycle 1, Day 15

    Outcome Measure Data

    Analysis Population Description
    Data was not collected as no participants were enrolled in Part 2 of the study
    Arm/Group Title Phase 1a Part 2 Expasion Cohort- INCB052793
    Arm/Group Description INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
    Measure Participants 0
    16. Secondary Outcome
    Title Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
    Description Tmax is the time to maximum (peak) observed plasma drug concentration.
    Time Frame Cycle 1, Day 15

    Outcome Measure Data

    Analysis Population Description
    Data was not collected as no participants were enrolled in Part 2 of the study
    Arm/Group Title Phase 1a Part 2 Expasion Cohort- INCB052793
    Arm/Group Description INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
    Measure Participants 0
    17. Secondary Outcome
    Title Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time
    Description AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t measured at steady state (Day 15).
    Time Frame Cycle 1, Day 15

    Outcome Measure Data

    Analysis Population Description
    Data was not collected as no participants were enrolled in Part 2 of the study
    Arm/Group Title Phase 1a Part 2 Expasion Cohort- INCB052793
    Arm/Group Description INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
    Measure Participants 0
    18. Secondary Outcome
    Title Phase 1a, Part 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
    Description AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
    Time Frame Cycle 1, Day 15

    Outcome Measure Data

    Analysis Population Description
    Data was not collected as no participants were enrolled in Part 2 of the study
    Arm/Group Title Phase 1a Part 2 Expasion Cohort- INCB052793
    Arm/Group Description INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
    Measure Participants 0
    19. Secondary Outcome
    Title Phase 1a, Part 2: Cmax: Maximum Observed Plasma Concentration for INCB052793
    Description Cmax is defined as the maximum observed plasma concentration measured at cycle 2 Day 1.
    Time Frame Cycle 2, Day 1

    Outcome Measure Data

    Analysis Population Description
    Data was not collected as no participants were enrolled in Part 2 of the study.
    Arm/Group Title Phase 1a Part 2 Expasion Cohort- INCB052793
    Arm/Group Description INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
    Measure Participants 0
    20. Secondary Outcome
    Title Phase 1a, Part 2: Cmin: Minimum Observed Plasma Concentration Over the Dose Interval
    Description Cmin is defined as the minimal observed plasma concentration measured at cycle 2 Day 1
    Time Frame Cycle 2, Day 1

    Outcome Measure Data

    Analysis Population Description
    Data was not collected as no participants were enrolled in Part 2 of the study.
    Arm/Group Title Phase 1a Part 2 Expasion Cohort- INCB052793
    Arm/Group Description INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
    Measure Participants 0
    21. Secondary Outcome
    Title Phase 1a, Part 2: Tmax: Time to Maximum Plasma Concentration for INCB052793
    Description Tmax is the time to maximum (peak) observed plasma drug concentration.
    Time Frame Cycle 2, Day 1

    Outcome Measure Data

    Analysis Population Description
    Data was not collected as no participants were enrolled in Part 2 of the study.
    Arm/Group Title Phase 1a Part 2 Expasion Cohort- INCB052793
    Arm/Group Description INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
    Measure Participants 0
    22. Secondary Outcome
    Title Phase 1a, Part 2: AUC[0-t]: Area Under the Plasma Concentration-Time Curve From Time 0 To the Last Measurable Concentration at Time
    Description AUC0-t is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
    Time Frame Cycle 2, Day 1

    Outcome Measure Data

    Analysis Population Description
    Data was not collected as no participants were enrolled in Part 2 of the study.
    Arm/Group Title Phase 1a Part 2 Expasion Cohort- INCB052793
    Arm/Group Description INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
    Measure Participants 0
    23. Secondary Outcome
    Title Phase 1a, Part 2: AUC0-τ: Area Under the Plasma Concentration-time Curve Over Dosing Interval for INCB052793
    Description AUC0-τ is the area under the plasma concentration-time curve from time = 0 to the last measurable concentration at time = t.
    Time Frame Cycle 2, Day 1

    Outcome Measure Data

    Analysis Population Description
    Data was not collected as no participants were enrolled in Part 2 of the study
    Arm/Group Title Phase 1a Part 2 Expasion Cohort- INCB052793
    Arm/Group Description INCB052793 35 mg tablet in combination with Azacitidine or Itacitinib 300mg in combination with Azacitidine
    Measure Participants 0

    Adverse Events

    Time Frame From first dose of study drug up to 30-35 days after last dose of study drug (Up to approximately 3.4 years)
    Adverse Event Reporting Description
    Arm/Group Title Phase 1a TGA - INCB052793 15 mg Phase 1a TGA - INCB052793 25 mg Phase 1a TGA - INCB052793 35 mg Phase 1a TGA - INCB052793 50 mg Phase 1a TGA - INCB052793 75 mg Phase 1a TGA - INCB052793 100 mg Phase 1a TGB - INCB052793 25 mg Phase 1a TGB - INCB052793 35 mg Phase 1a TGB - INCB052793 50 mg Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
    Arm/Group Description INCB052793 15 mg tablet, orally (PO), once daily (QD) in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 78.3 days ). INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 96.3 days). INCB052793 35 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 80.3 days). INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 46.5 days). INCB052793 75 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 459.0 days). INCB052793 100 mg tablet, PO, QD in the fasted state in participants with advanced or metastatic solid tumors treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 44.0 days). INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 248.7 days). INCB052793 25 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 342.8 days). INCB052793 50 mg tablet, PO, QD in the fasted state in participants with advanced hematologic malignancies treated in continuous 21 day cycles until they met treatment discontinuation criteria (Up to mean duration of exposure of approximately 76.3 days). INCB052793 25 mg tablet, PO, QD in the fasted state in participants with multiple myeloma (MM) in continuous 21 day cycles until they met treatment discontinuation criteria plus Dexamethasone 40 mg, PO, weekly for each 28-day cycle (Up to mean duration of exposure of approximately 53.6 days). INCB052793 25 mg tablet, PO, QD in the fasted state in participants with acute myeloid leukemia (AML)/ myelodysplastic syndrome (MDS) in continuous 21 day cycles until they met treatment discontinuation criteria plus Azacitidine 75 mg/m^2, subcutaneous (SC) injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 151.2 days). INCB052793 35 mg tablet, PO, QD in the fasted state in participants with AML/MDS in continuous 21 day cycles until they met treatment discontinuation criteria Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 142.1 days). INCB052793 35 mg tablet, PO, QD in the fasted state in participants with hypomethylating agent-refractory (HMA)-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 86.2 days). Itacitinib 300 mg sustained-release tablet, PO, QD in the fasted state in participants with HMA-refractory AML and high-risk MDS in continuous 21 day cycles until they met treatment discontinuation criteria. Azacitidine 75 mg/m^2, SC injection for 5 days, then no treatment for 2 days, then 75 mg/m^2 for 2 days for each 28-day cycle (Up to mean duration of exposure of approximately 143 days).
    All Cause Mortality
    Phase 1a TGA - INCB052793 15 mg Phase 1a TGA - INCB052793 25 mg Phase 1a TGA - INCB052793 35 mg Phase 1a TGA - INCB052793 50 mg Phase 1a TGA - INCB052793 75 mg Phase 1a TGA - INCB052793 100 mg Phase 1a TGB - INCB052793 25 mg Phase 1a TGB - INCB052793 35 mg Phase 1a TGB - INCB052793 50 mg Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
    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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/3 (66.7%) 0/3 (0%) 2/6 (33.3%) 2/4 (50%) 1/3 (33.3%) 3/6 (50%) 2/3 (66.7%) 1/4 (25%) 3/4 (75%) 3/7 (42.9%) 4/5 (80%) 12/16 (75%) 7/9 (77.8%) 6/10 (60%)
    Serious Adverse Events
    Phase 1a TGA - INCB052793 15 mg Phase 1a TGA - INCB052793 25 mg Phase 1a TGA - INCB052793 35 mg Phase 1a TGA - INCB052793 50 mg Phase 1a TGA - INCB052793 75 mg Phase 1a TGA - INCB052793 100 mg Phase 1a TGB - INCB052793 25 mg Phase 1a TGB - INCB052793 35 mg Phase 1a TGB - INCB052793 50 mg Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
    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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 2/4 (50%) 3/3 (100%) 2/6 (33.3%) 1/3 (33.3%) 2/4 (50%) 2/4 (50%) 5/7 (71.4%) 4/5 (80%) 14/16 (87.5%) 7/9 (77.8%) 8/10 (80%)
    Blood and lymphatic system disorders
    Febrile neutropenia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 4/5 (80%) 9/16 (56.3%) 3/9 (33.3%) 5/10 (50%)
    Lymphadenopathy 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Bone marrow failure 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Cardiac disorders
    Tachycardia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    myocardial ischaemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Cardiac failure 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Gastrointestinal disorders
    Gastrointestinal haemorrhage 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Intestinal obstruction 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0 0/4 (0%) 0 0/4 (0%) 0 0/7 (0%) 0 0/5 (0%) 0 0/16 (0%) 0 0/9 (0%) 0 0/10 (0%) 0
    Nausea 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Small intestinal obstruction 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Vomiting 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Abdominal pain 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    General disorders
    Fatigue 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Pyrexia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 4/16 (25%) 0/9 (0%) 0/10 (0%)
    Infections and infestations
    Pneumonia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 1/6 (16.7%) 1/3 (33.3%) 0/4 (0%) 0/4 (0%) 3/7 (42.9%) 1/5 (20%) 1/16 (6.3%) 1/9 (11.1%) 0/10 (0%)
    Staphylococcal bacteraemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Sepsis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 3/7 (42.9%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Herpes zoster 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Pharyngitis streptococcal 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Bronchopulmonary aspergillosis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Lung infection 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Oral fungal infection 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Pneumonia fungal 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 1/9 (11.1%) 0/10 (0%)
    Respiratory syncytial virus infection 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Septic arthritis staphylococcal 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Staphylococcal sepsis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Urinary tract infection 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Injury, poisoning and procedural complications
    Fall 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Fractured sacrum 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Transfusion-related circulatory overload 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Transfusion reaction 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Toxicity to various agents 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Investigations
    Platelet count decreased 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    ECG signs of myocardial ischaemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Metabolism and nutrition disorders
    Dehydration 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Hypercalcaemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Hyponatraemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Musculoskeletal and connective tissue disorders
    Muscular weakness 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Arthralgia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Bone pain 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma metastatic 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Acute myeloid leukaemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Chloroma 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Nervous system disorders
    Encephalopathy 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Spinal cord compression 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Syncope 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Dizziness 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Renal and urinary disorders
    Urinary tract obstruction 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Renal failure acute 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Haemoptysis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Respiratory failure 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Pleural effusion 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Pulmonary toxicity 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Respiratory arrest 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Wheezing 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Acute respiratory distress syndrome 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Cough 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Nasal congestion 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Organising pneumonia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Pulmonary embolism 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 2/10 (20%)
    Skin and subcutaneous tissue disorders
    Acute febrile neutrophilic dermatosis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Vascular disorders
    Embolism 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Other (Not Including Serious) Adverse Events
    Phase 1a TGA - INCB052793 15 mg Phase 1a TGA - INCB052793 25 mg Phase 1a TGA - INCB052793 35 mg Phase 1a TGA - INCB052793 50 mg Phase 1a TGA - INCB052793 75 mg Phase 1a TGA - INCB052793 100 mg Phase 1a TGB - INCB052793 25 mg Phase 1a TGB - INCB052793 35 mg Phase 1a TGB - INCB052793 50 mg Phase 1b Cohort B - INCB052793 25 mg + Dexamethasone 40 mg Phase 1b Cohort F - INCB052793 25 mg + Azacytidine 75 mg/m^2 Phase 1b Cohort F - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort I - INCB052793 35 mg + Azacytidine 75 mg/m^2 Phase 2 Cohort J - Itacitinib 300 mg + Azacitidine 75 mg/m^2
    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 Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 3/3 (100%) 3/3 (100%) 6/6 (100%) 4/4 (100%) 3/3 (100%) 6/6 (100%) 3/3 (100%) 4/4 (100%) 4/4 (100%) 7/7 (100%) 5/5 (100%) 16/16 (100%) 9/9 (100%) 10/10 (100%)
    Blood and lymphatic system disorders
    Anaemia 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 3/3 (100%) 1/6 (16.7%) 1/3 (33.3%) 1/4 (25%) 1/4 (25%) 3/7 (42.9%) 2/5 (40%) 10/16 (62.5%) 2/9 (22.2%) 0/10 (0%)
    Febrile neutropenia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Increased tendency to bruise 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Leukocytosis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Leukopenia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 2/16 (12.5%) 2/9 (22.2%) 0/10 (0%)
    Neutropenia 1/3 (33.3%) 0/3 (0%) 2/6 (33.3%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 2/4 (50%) 1/4 (25%) 1/7 (14.3%) 1/5 (20%) 4/16 (25%) 1/9 (11.1%) 0/10 (0%)
    Thrombocytopenia 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 1/4 (25%) 1/3 (33.3%) 3/6 (50%) 0/3 (0%) 2/4 (50%) 1/4 (25%) 4/7 (57.1%) 1/5 (20%) 7/16 (43.8%) 2/9 (22.2%) 0/10 (0%)
    Thrombocytosis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Haemolysis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Cardiac disorders
    Angina pectoris 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Atrial fibrillation 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 1/10 (10%)
    Palpitations 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Pericardial effusion 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Sinus bradycardia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Sinus tachycardia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Tachycardia 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Ear and labyrinth disorders
    Ear pain 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Hearing impaired 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Tinnitus 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Endocrine disorders
    Adrenal insufficiency 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Eye disorders
    Blepharospasm 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Conjunctival haemorrhage 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Dry eye 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 1/3 (33.3%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Eye oedema 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Eye pain 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Eye swelling 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Periorbital oedema 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Scleral haemorrhage 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Vision blurred 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Visual impairment 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Gastrointestinal disorders
    Abdominal discomfort 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Abdominal distension 0/3 (0%) 1/3 (33.3%) 1/6 (16.7%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Abdominal pain 0/3 (0%) 2/3 (66.7%) 2/6 (33.3%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 1/4 (25%) 2/7 (28.6%) 2/5 (40%) 3/16 (18.8%) 0/9 (0%) 1/10 (10%)
    Abdominal pain upper 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 1/10 (10%)
    Anal pruritus 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Anal ulcer 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Aphthous stomatitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 2/3 (66.7%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Ascites 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Constipation 2/3 (66.7%) 0/3 (0%) 1/6 (16.7%) 1/4 (25%) 2/3 (66.7%) 3/6 (50%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 1/7 (14.3%) 3/5 (60%) 8/16 (50%) 4/9 (44.4%) 3/10 (30%)
    Dental caries 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Diarrhoea 0/3 (0%) 0/3 (0%) 2/6 (33.3%) 1/4 (25%) 1/3 (33.3%) 2/6 (33.3%) 1/3 (33.3%) 0/4 (0%) 1/4 (25%) 1/7 (14.3%) 2/5 (40%) 5/16 (31.3%) 3/9 (33.3%) 5/10 (50%)
    Dry mouth 1/3 (33.3%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Dyspepsia 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 1/4 (25%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Dysphagia 1/3 (33.3%) 1/3 (33.3%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Faeces discoloured 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Flatulence 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Frequent bowel movements 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Gastrointestinal pain 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Gastrointestinal sounds abnormal 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Gastrooesophageal reflux disease 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 2/9 (22.2%) 0/10 (0%)
    Gingival bleeding 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Gingival hyperplasia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Haematochezia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Haemorrhoids 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Malabsorption 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Mouth haemorrhage 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Mouth ulceration 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Nausea 1/3 (33.3%) 2/3 (66.7%) 3/6 (50%) 0/4 (0%) 1/3 (33.3%) 2/6 (33.3%) 1/3 (33.3%) 1/4 (25%) 2/4 (50%) 2/7 (28.6%) 1/5 (20%) 7/16 (43.8%) 2/9 (22.2%) 2/10 (20%)
    Odynophagia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Oesophagitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Oral dysaesthesia 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Oral pain 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 2/10 (20%)
    Proctalgia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Rectal haemorrhage 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Stomatitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 3/6 (50%) 1/3 (33.3%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 1/5 (20%) 5/16 (31.3%) 0/9 (0%) 1/10 (10%)
    Tongue disorder 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Tongue ulceration 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Toothache 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Vomiting 1/3 (33.3%) 2/3 (66.7%) 1/6 (16.7%) 0/4 (0%) 1/3 (33.3%) 2/6 (33.3%) 1/3 (33.3%) 1/4 (25%) 3/4 (75%) 1/7 (14.3%) 1/5 (20%) 3/16 (18.8%) 0/9 (0%) 2/10 (20%)
    General disorders
    Application site pruritus 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Asthenia 1/3 (33.3%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Catheter site bruise 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Catheter site erythema 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Chest discomfort 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Chills 0/3 (0%) 1/3 (33.3%) 2/6 (33.3%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 1/3 (33.3%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 1/5 (20%) 2/16 (12.5%) 1/9 (11.1%) 3/10 (30%)
    Device occlusion 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Energy increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Facial pain 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Fatigue 1/3 (33.3%) 1/3 (33.3%) 3/6 (50%) 2/4 (50%) 2/3 (66.7%) 3/6 (50%) 0/3 (0%) 0/4 (0%) 3/4 (75%) 2/7 (28.6%) 3/5 (60%) 8/16 (50%) 2/9 (22.2%) 5/10 (50%)
    Influenza like illness 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Injection site bruising 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 2/16 (12.5%) 1/9 (11.1%) 0/10 (0%)
    Injection site erythema 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 1/10 (10%)
    Injection site pain 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 1/9 (11.1%) 0/10 (0%)
    Injection site reaction 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 3/5 (60%) 5/16 (31.3%) 4/9 (44.4%) 0/10 (0%)
    Localised oedema 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Malaise 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Mass 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Medical device pain 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Nodule 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Non-cardiac chest pain 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Oedema 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Oedema peripheral 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 3/16 (18.8%) 1/9 (11.1%) 3/10 (30%)
    Peripheral swelling 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Pyrexia 1/3 (33.3%) 2/3 (66.7%) 2/6 (33.3%) 0/4 (0%) 2/3 (66.7%) 3/6 (50%) 1/3 (33.3%) 2/4 (50%) 0/4 (0%) 3/7 (42.9%) 1/5 (20%) 5/16 (31.3%) 3/9 (33.3%) 2/10 (20%)
    Temperature intolerance 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Vessel puncture site bruise 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Hepatobiliary disorders
    Cholelithiasis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Jaundice 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Immune system disorders
    Graft versus host disease in skin 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Infections and infestations
    Bacteriuria 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 1/3 (33.3%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Bronchitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Candida infection 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Chronic sinusitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Clostridium difficile colitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Conjunctivitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Corona virus infection 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Device related infection 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Empyema 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Eye infection bacterial 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 1/3 (33.3%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Folliculitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Fungal skin infection 1/3 (33.3%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Gingival abscess 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Gingivitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Herpes simplex 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Herpes zoster 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 2/3 (66.7%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Hordeolum 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Lung infection 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Nasopharyngitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Oral candidiasis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Oral herpes 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Pharyngitis streptococcal 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Pneumonia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Pneumonia fungal 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 1/10 (10%)
    Pneumonia respiratory syncytial viral 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Rash pustular 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Rhinitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Sepsis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Sinusitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 1/6 (16.7%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Staphylococcal infection 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Staphylococcal skin infection 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Tooth infection 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Upper respiratory tract infection 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 1/3 (33.3%) 1/6 (16.7%) 1/3 (33.3%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 1/5 (20%) 1/16 (6.3%) 0/9 (0%) 2/10 (20%)
    Urinary tract infection 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 1/3 (33.3%) 0/6 (0%) 1/3 (33.3%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 1/9 (11.1%) 1/10 (10%)
    Injury, poisoning and procedural complications
    Compression fracture 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Contusion 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 1/16 (6.3%) 0/9 (0%) 1/10 (10%)
    Fall 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 2/16 (12.5%) 0/9 (0%) 1/10 (10%)
    Humerus fracture 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Infusion related reaction 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 1/10 (10%)
    Laceration 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Limb injury 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Periorbital contusion 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Post procedural swelling 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Procedural pain 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Skin abrasion 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Transfusion reaction 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 1/10 (10%)
    Traumatic haematoma 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Wound dehiscence 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Investigations
    Activated partial thromboplastin time prolonged 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 2/16 (12.5%) 0/9 (0%) 0/10 (0%)
    Alanine aminotransferase increased 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 1/7 (14.3%) 2/5 (40%) 6/16 (37.5%) 3/9 (33.3%) 0/10 (0%)
    Aspartate aminotransferase increased 1/3 (33.3%) 0/3 (0%) 4/6 (66.7%) 1/4 (25%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 1/7 (14.3%) 1/5 (20%) 5/16 (31.3%) 4/9 (44.4%) 0/10 (0%)
    Blood alkaline phosphatase increased 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 1/4 (25%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 2/5 (40%) 3/16 (18.8%) 2/9 (22.2%) 0/10 (0%)
    Blood bilirubin increased 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 1/7 (14.3%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 2/10 (20%)
    Blood cholesterol increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 3/16 (18.8%) 3/9 (33.3%) 0/10 (0%)
    Blood creatinine increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 1/9 (11.1%) 1/10 (10%)
    Blood fibrinogen decreased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Blood iron increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Blood lactate dehydrogenase increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 2/16 (12.5%) 1/9 (11.1%) 0/10 (0%)
    Blood magnesium decreased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 1/3 (33.3%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Blood phosphorus increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 1/9 (11.1%) 0/10 (0%)
    Blood triglycerides increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 2/16 (12.5%) 0/9 (0%) 0/10 (0%)
    Blood urea increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 2/9 (22.2%) 0/10 (0%)
    C-reactive protein increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Electrocardiogram QT prolonged 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 2/9 (22.2%) 0/10 (0%)
    Electrocardiogram ST segment abnormal 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Electrocardiogram T wave abnormal 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Electrocardiogram abnormal 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Gamma-glutamyltransferase increased 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Haemoglobin decreased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Human papilloma virus test positive 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 1/3 (33.3%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Lymphocyte count decreased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Neutrophil count decreased 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 1/4 (25%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 1/7 (14.3%) 2/5 (40%) 3/16 (18.8%) 1/9 (11.1%) 1/10 (10%)
    Platelet count decreased 0/3 (0%) 0/3 (0%) 3/6 (50%) 2/4 (50%) 0/3 (0%) 2/6 (33.3%) 0/3 (0%) 1/4 (25%) 1/4 (25%) 1/7 (14.3%) 2/5 (40%) 4/16 (25%) 1/9 (11.1%) 1/10 (10%)
    Platelet count increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Reticulocyte count decreased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Reticulocyte count increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Serum ferritin increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Staphylococcus test positive 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Troponin I increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Weight decreased 0/3 (0%) 1/3 (33.3%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 1/5 (20%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    White blood cell count decreased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 2/16 (12.5%) 0/9 (0%) 0/10 (0%)
    White blood cell count increased 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 1/3 (33.3%) 1/3 (33.3%) 2/6 (33.3%) 0/4 (0%) 1/3 (33.3%) 2/6 (33.3%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 1/5 (20%) 3/16 (18.8%) 1/9 (11.1%) 4/10 (40%)
    Dehydration 0/3 (0%) 1/3 (33.3%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 2/6 (33.3%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 2/9 (22.2%) 0/10 (0%)
    Fluid overload 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Hypercalcaemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Hypercholesterolaemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Hyperglycaemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 4/16 (25%) 1/9 (11.1%) 0/10 (0%)
    Hyperkalaemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Hyperlipidaemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Hypernatraemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Hyperphosphataemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Hypertriglyceridaemia 0/3 (0%) 0/3 (0%) 2/6 (33.3%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 2/7 (28.6%) 1/5 (20%) 4/16 (25%) 5/9 (55.6%) 1/10 (10%)
    Hyperuricaemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 1/7 (14.3%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Hypocalcaemia 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Hypokalaemia 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 1/3 (33.3%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 2/7 (28.6%) 1/5 (20%) 1/16 (6.3%) 0/9 (0%) 1/10 (10%)
    Hypomagnesaemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Hyponatraemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 1/9 (11.1%) 1/10 (10%)
    Hypophosphataemia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 3/7 (42.9%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Increased appetite 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Iron overload 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Vitamin B12 deficiency 1/3 (33.3%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Vitamin D deficiency 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/3 (33.3%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 2/16 (12.5%) 0/9 (0%) 3/10 (30%)
    Back pain 1/3 (33.3%) 0/3 (0%) 1/6 (16.7%) 2/4 (50%) 0/3 (0%) 0/6 (0%) 1/3 (33.3%) 0/4 (0%) 1/4 (25%) 1/7 (14.3%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 1/10 (10%)
    Bone pain 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 1/7 (14.3%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Bursitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Flank pain 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Groin pain 1/3 (33.3%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Joint effusion 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Muscle spasms 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 1/3 (33.3%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 1/5 (20%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Muscular weakness 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 3/10 (30%)
    Musculoskeletal pain 1/3 (33.3%) 0/3 (0%) 1/6 (16.7%) 1/4 (25%) 1/3 (33.3%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Musculoskeletal stiffness 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Myalgia 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 2/7 (28.6%) 1/5 (20%) 2/16 (12.5%) 0/9 (0%) 3/10 (30%)
    Neck pain 1/3 (33.3%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Pain in extremity 1/3 (33.3%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 1/7 (14.3%) 0/5 (0%) 2/16 (12.5%) 0/9 (0%) 1/10 (10%)
    Nervous system disorders
    Amnesia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Aphasia 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Cerebrovascular accident 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Dizziness 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 1/6 (16.7%) 1/3 (33.3%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 2/16 (12.5%) 0/9 (0%) 2/10 (20%)
    Dysgeusia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 2/6 (33.3%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 1/16 (6.3%) 1/9 (11.1%) 2/10 (20%)
    Headache 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 1/4 (25%) 0/7 (0%) 1/5 (20%) 4/16 (25%) 1/9 (11.1%) 2/10 (20%)
    Hypoaesthesia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 1/3 (33.3%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Hypogeusia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Memory impairment 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Neuralgia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Neuropathy peripheral 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 2/3 (66.7%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Paraesthesia 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Paraplegia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Post herpetic neuralgia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Presyncope 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Sinus headache 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Somnolence 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 2/7 (28.6%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Speech disorder 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Syncope 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Tension headache 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Tremor 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Psychiatric disorders
    Anxiety 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Confusional state 1/3 (33.3%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 1/10 (10%)
    Depression 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Hallucination 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Insomnia 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 2/4 (50%) 0/7 (0%) 1/5 (20%) 2/16 (12.5%) 0/9 (0%) 0/10 (0%)
    Irritability 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Mental status changes 1/3 (33.3%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Renal and urinary disorders
    Dysuria 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 2/16 (12.5%) 0/9 (0%) 0/10 (0%)
    Haematuria 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 2/4 (50%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 3/16 (18.8%) 0/9 (0%) 0/10 (0%)
    Nephrolithiasis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Neurogenic bladder 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Pollakiuria 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 2/9 (22.2%) 0/10 (0%)
    Renal failure acute 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Urinary incontinence 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Urinary retention 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Urinary tract pain 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Testicular oedema 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Testicular pain 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Vaginal haemorrhage 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Cough 0/3 (0%) 1/3 (33.3%) 0/6 (0%) 2/4 (50%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 2/5 (40%) 2/16 (12.5%) 0/9 (0%) 3/10 (30%)
    Dysphonia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Dyspnoea 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 2/3 (66.7%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 2/7 (28.6%) 1/5 (20%) 1/16 (6.3%) 3/9 (33.3%) 4/10 (40%)
    Dyspnoea exertional 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 2/16 (12.5%) 0/9 (0%) 0/10 (0%)
    Epistaxis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 1/7 (14.3%) 0/5 (0%) 3/16 (18.8%) 0/9 (0%) 3/10 (30%)
    Haemoptysis 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Haemothorax 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Hiccups 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Hypoxia 0/3 (0%) 0/3 (0%) 0/6 (0%) 1/4 (25%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 1/16 (6.3%) 0/9 (0%) 2/10 (20%)
    Nasal congestion 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 1/7 (14.3%) 1/5 (20%) 2/16 (12.5%) 0/9 (0%) 1/10 (10%)
    Oropharyngeal pain 0/3 (0%) 1/3 (33.3%) 1/6 (16.7%) 0/4 (0%) 1/3 (33.3%) 2/6 (33.3%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 1/7 (14.3%) 2/5 (40%) 3/16 (18.8%) 4/9 (44.4%) 2/10 (20%)
    Pleural effusion 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 1/16 (6.3%) 0/9 (0%) 1/10 (10%)
    Pleuritic pain 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Pneumonitis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 2/7 (28.6%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Productive cough 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 2/16 (12.5%) 1/9 (11.1%) 0/10 (0%)
    Pulmonary embolism 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 2/3 (66.7%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Pulmonary toxicity 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Rhinitis allergic 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Sinus congestion 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 1/3 (33.3%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Sinus disorder 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Tonsillar hypertrophy 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Upper-airway cough syndrome 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 2/16 (12.5%) 1/9 (11.1%) 0/10 (0%)
    Wheezing 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Skin and subcutaneous tissue disorders
    Acne 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Acute febrile neutrophilic dermatosis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Alopecia 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Blister 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Dermatitis acneiform 1/3 (33.3%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 2/3 (66.7%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 2/16 (12.5%) 0/9 (0%) 0/10 (0%)
    Dermatitis contact 0/3 (0%) 0/3 (0%) 1/6 (16.7%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Dry skin 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 1/6 (16.7%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Erythema 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Hyperhidrosis 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Night sweats 1/3 (33.3%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 1/9 (11.1%) 0/10 (0%)
    Pain of skin 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Pruritus 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 1/10 (10%)
    Purpura 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Rash 1/3 (33.3%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 1/4 (25%) 0/7 (0%) 0/5 (0%) 2/16 (12.5%) 0/9 (0%) 0/10 (0%)
    Rash follicular 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 1/7 (14.3%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Rash maculo-papular 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 1/3 (33.3%) 0/4 (0%) 0/4 (0%) 2/7 (28.6%) 1/5 (20%) 5/16 (31.3%) 0/9 (0%) 1/10 (10%)
    Rash papular 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 0/9 (0%) 0/10 (0%)
    Skin lesion 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 1/9 (11.1%) 0/10 (0%)
    Skin mass 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 1/4 (25%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Urticaria 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Surgical and medical procedures
    Tooth extraction 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Vascular disorders
    Deep vein thrombosis 0/3 (0%) 0/3 (0%) 2/6 (33.3%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 0/16 (0%) 0/9 (0%) 0/10 (0%)
    Haematoma 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 1/16 (6.3%) 1/9 (11.1%) 1/10 (10%)
    Hot flush 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 2/16 (12.5%) 0/9 (0%) 0/10 (0%)
    Hypertension 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 0/5 (0%) 3/16 (18.8%) 0/9 (0%) 0/10 (0%)
    Hypotension 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 1/3 (33.3%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 1/10 (10%)
    Orthostatic hypotension 0/3 (0%) 0/3 (0%) 0/6 (0%) 0/4 (0%) 0/3 (0%) 0/6 (0%) 0/3 (0%) 0/4 (0%) 0/4 (0%) 0/7 (0%) 1/5 (20%) 0/16 (0%) 0/9 (0%) 0/10 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Study Director
    Organization Incyte Corporation
    Phone 1-855-463-3463
    Email medinfo@incyte.com
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT02265510
    Other Study ID Numbers:
    • INCB 52793-101
    First Posted:
    Oct 16, 2014
    Last Update Posted:
    Apr 17, 2020
    Last Verified:
    Apr 1, 2020