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NCT01953692 · ADVERSE EVENTS

Adverse events

A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013) · Source last updated 2021-08-04

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 approximately 78.5 months
Other-event reporting threshold
5%

The analysis population for adverse events (AEs) consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to study treatment are excluded.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: Myelodysplastic Syndrome (MDS)

Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle

20 / 2825 / 2825 / 28
Cohort 2: Relapsed Refractory or Refractory(rR/R) Multiple Myeloma (MM)

Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.

9 / 3027 / 3023 / 30
Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)

Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.

13 / 3130 / 318 / 31
Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)

Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.

8 / 2121 / 2111 / 21
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas

Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.

2 / 44 / 44 / 4
Cohort 4C: R/R Follicular Lymphoma (FL)

Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.

8 / 2221 / 2211 / 22
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle

22 / 4234 / 4237 / 42
Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D)

Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.

4 / 1313 / 138 / 13
Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg

Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles. The 25 mg dose of lenalidomide was the starting dose for dose determination.

1 / 65 / 64 / 6

Group identifiers: EG000: Cohort 1: Myelodysplastic Syndrome (MDS) · EG001: Cohort 2: Relapsed Refractory or Refractory(rR/R) Multiple Myeloma (MM) · EG002: Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL) · EG003: Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL) · EG004: Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas · EG005: Cohort 4C: R/R Follicular Lymphoma (FL) · EG006: Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL) · EG007: Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D) · EG008: Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      22
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      42
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Aortic valve disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Myocardial ischaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hyperthyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      13
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Constipation

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      30
      num Events
      12
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      31
      num Events
      6
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      21
      num Events
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      22
      num Events
      4
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      42
      num Events
      14
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      13
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      22
      num Events
      1
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      42
      num Events
      15
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      21
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      42
      num Events
      15
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      13
      num Events
      10
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      6
      num Events
      4
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      30
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      22
      num Events
      3
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      42
      num Events
      6
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      13
      num Events
      4
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      6
      num Events
      3
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      2
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      22
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      42
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Ear pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypoacusis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      13
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Middle ear inflammation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      13
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      28
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      31
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      42
      num Events
      3
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      13
      num Events
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thyroiditis
Complete source fields
description
The analysis population for adverse events (AEs) consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "neoplasm progression", "malignant neoplasm progression" and "disease progression" not related to study treatment are excluded.
event Groups
  1. deaths Num Affected
    25
    deaths Num At Risk
    28
    description
    Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle
    id
    EG000
    other Num Affected
    25
    other Num At Risk
    28
    serious Num Affected
    20
    serious Num At Risk
    28
    title
    Cohort 1: Myelodysplastic Syndrome (MDS)
  2. deaths Num Affected
    23
    deaths Num At Risk
    30
    description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    EG001
    other Num Affected
    27
    other Num At Risk
    30
    serious Num Affected
    9
    serious Num At Risk
    30
    title
    Cohort 2: Relapsed Refractory or Refractory(rR/R) Multiple Myeloma (MM)
  3. deaths Num Affected
    8
    deaths Num At Risk
    31
    description
    Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    EG002
    other Num Affected
    30
    other Num At Risk
    31
    serious Num Affected
    13
    serious Num At Risk
    31
    title
    Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
  4. deaths Num Affected
    11
    deaths Num At Risk
    21
    description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    EG003
    other Num Affected
    21
    other Num At Risk
    21
    serious Num Affected
    8
    serious Num At Risk
    21
    title
    Cohort 4A: R/R Primary Mediastinal B-cell Lymphoma (PMBCL)
  5. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
  6. deaths Num Affected
    11
    deaths Num At Risk
    22
    description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
    id
    EG005
    other Num Affected
    21
    other Num At Risk
    22
    serious Num Affected
    8
    serious Num At Risk
    22
    title
    Cohort 4C: R/R Follicular Lymphoma (FL)
  7. deaths Num Affected
    37
    deaths Num At Risk
    42
    description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle
    id
    EG006
    other Num Affected
    34
    other Num At Risk
    42
    serious Num Affected
    22
    serious Num At Risk
    42
    title
    Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
  8. deaths Num Affected
    8
    deaths Num At Risk
    13
    description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
    id
    EG007
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    4
    serious Num At Risk
    13
    title
    Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 20 mg (RP2D)
  9. deaths Num Affected
    4
    deaths Num At Risk
    6
    description
    Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles. The 25 mg dose of lenalidomide was the starting dose for dose determination.
    id
    EG008
    other Num Affected
    5
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    Cohort 5: R/R DLBCL Pembrolizumab+Lenalidomide 25 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      30
      num Events
      12
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      31
      num Events
      6
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      21
      num Events
      8
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      22
      num Events
      4
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      42
      num Events
      14
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      13
      num Events
      1
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      22
      num Events
      1
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      42
      num Events
      15
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      21
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      42
      num Events
      15
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      13
      num Events
      10
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      6
      num Events
      4
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      30
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      22
      num Events
      3
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      42
      num Events
      6
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      13
      num Events
      4
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      6
      num Events
      3
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      2
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      22
      num Events
      2
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      42
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Ear pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      4
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypoacusis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      13
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Middle ear inflammation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      13
      num Events
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      28
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      31
      num Events
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      21
      num Events
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      42
      num Events
      3
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      13
      num Events
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thyroiditis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      30
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      31
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      28
      num Events
      9
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      21
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      22
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      42
      num Events
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      30
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Aortic valve disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Myocardial ischaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      42
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hyperthyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      31
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      13
      num Events
      1
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Colitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      30
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      31
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      21
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      22
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      42
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      13
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Constipation
time Frame
Up to approximately 78.5 months

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Preserved source evidence · Not medical advice