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NCT02595866 · ADVERSE EVENTS

Adverse events

Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer · Source last updated 2024-08-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months.
Other-event reporting threshold
5%

Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1 (Pembrolizumab and cART)

Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT

8 / 1010 / 105 / 10
Cohort 2 (Pembrolizumab and cART)

Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT

8 / 1212 / 125 / 12
Cohort 3 (Pembrolizumab and cART)

Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT

6 / 1212 / 125 / 12
Cohort 4 (Pembrolizumab and cART)

Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT

9 / 2424 / 242 / 24
Total

Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT

31 / 5858 / 5817 / 58

Group identifiers: EG000: Cohort 1 (Pembrolizumab and cART) · EG001: Cohort 2 (Pembrolizumab and cART) · EG002: Cohort 3 (Pembrolizumab and cART) · EG003: Cohort 4 (Pembrolizumab and cART) · EG004: Total

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      58
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Hemolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Retinal detachment
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      58
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      58
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      58
    term
    Nausea

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      33
      num At Risk
      58
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      58
    term
    Sinus tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      58
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      58
    term
    Blurred vision
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      58
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      58
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      58
    term
    Bloating
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      17
      num At Risk
      58
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      58
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      58
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      58
    term
    Gastroesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      58
    term
    Nausea
Complete source fields
description
Will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (version 5.0 beginning April 1, 2018). Safety and tolerability will be assessed by summarizing all relevant parameters including AEs, serious AEs, laboratory tests, vital signs, and electrocardiogram measurements. All summaries will be presented for each cohort and overall.
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    10
    description
    Participants enrolled into Cohort 1 (50-199 CD4+ T cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    8
    serious Num At Risk
    10
    title
    Cohort 1 (Pembrolizumab and cART)
  2. deaths Num Affected
    5
    deaths Num At Risk
    12
    description
    Participants enrolled into Cohort 2 (200-350 CD4+ cells/mcL), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    8
    serious Num At Risk
    12
    title
    Cohort 2 (Pembrolizumab and cART)
  3. deaths Num Affected
    5
    deaths Num At Risk
    12
    description
    Participants enrolled into Cohort 3 (\> 350 CD4+ cells/mcl), who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo CT or PET/CT and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
    id
    EG002
    other Num Affected
    12
    other Num At Risk
    12
    serious Num Affected
    6
    serious Num At Risk
    12
    title
    Cohort 3 (Pembrolizumab and cART)
  4. deaths Num Affected
    2
    deaths Num At Risk
    24
    description
    Participants with HIV associated Kaposi sarcoma enrolled into cohort 4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants undergo physical examination and blood sample collection, and may undergo CT or PET/CT. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
    id
    EG003
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    9
    serious Num At Risk
    24
    title
    Cohort 4 (Pembrolizumab and cART)
  5. deaths Num Affected
    17
    deaths Num At Risk
    58
    description
    Participants enrolled into Cohorts 1-4, who receive pembrolizumab IV over 30 minutes on day 1. Participants continue receiving their recommended combination antiretroviral therapy per established regimen. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Participants also undergo physical examination, CT or PET/CT, and blood sample collection throughout the trial. Participants may also undergo biopsies during screening and on study. Antiretroviral Therapy: Given PO Biopsy: Undergo biopsy Biospecimen Collection: Undergo blood sample collection Computed Tomography: Undergo CT or PET/CT Pembrolizumab: Given IV Positron Emission Tomography: Undergo PET/CT
    id
    EG004
    other Num Affected
    58
    other Num At Risk
    58
    serious Num Affected
    31
    serious Num At Risk
    58
    title
    Total
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      33
      num At Risk
      58
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      58
    term
    Sinus tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      58
    term
    Hypothyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      58
    term
    Blurred vision
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      58
    term
    Dry eye
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      58
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      58
    term
    Bloating
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      17
      num At Risk
      58
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      58
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      58
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      58
    term
    Gastroesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      58
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      58
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Hemolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Sinus tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      58
    term
    Retinal detachment
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      58
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      58
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (12.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      24
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      58
    term
    Nausea
time Frame
Up to 90 days after the last dose of trial treatment, up to 2 years or 35 cycles of trial treatment. All cause mortality was assessed for up to 36 months.

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Preserved source evidence · Not medical advice