Skip to content
← Full study record

NCT03517449 · ADVERSE EVENTS

Adverse events

Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775]) · Source last updated 2026-03-19

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 79 months
Other-event reporting threshold
5%

All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
First Course: Lenvatinib + Pembrolizumab

Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study

237 / 406404 / 406317 / 406
First Course: TPC Doxorubicin or Paclitaxel

Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.

121 / 388379 / 388362 / 388
Second Course: Lenvatinib + Pembrolizumab

Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) and lenvatinib (\~2years) or who had Stable disease (SD) or partial response (PR) or had attained complete response (CR), but experienced radiologic progression of disease (PD) initiated a second course of pembrolizumab and lenvatinib at investigators discretion at the same dose and schedule at lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle upto 17 cycles (upto \~1 year)

4 / 2120 / 218 / 21
TPC Crossover

Eligible participants who completed the first course of either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle and eligible participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care or who had Stable disease (SD) or partial response (PR) or had attained complete response (CR), but experienced radiologic progression of disease (PD) initiated treatment with pembrolizumab and lenvatinib at investigators discretion at the same dose and schedule at lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle upto 17 cycles (upto \~1 year)

1 / 66 / 61 / 6

Group identifiers: EG000: First Course: Lenvatinib + Pembrolizumab · EG001: First Course: TPC Doxorubicin or Paclitaxel · EG002: Second Course: Lenvatinib + Pembrolizumab · EG003: TPC Crossover

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
      num Events
      1
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      388
      num Events
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      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 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      406
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      406
      num Events
      2
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      388
      num Events
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      406
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      406
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      388
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
      num Events
      1
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      388
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      406
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Neutrophilia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thrombotic microangiopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      406
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Acute coronary syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      406
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Acute myocardial infarction

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      115
      num At Risk
      406
      num Events
      171
    2. group Id
      EG001
      num Affected
      181
      num At Risk
      388
      num Events
      240
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      406
      num Events
      72
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      388
      num Events
      89
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      406
      num Events
      61
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      388
      num Events
      45
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      406
      num Events
      106
    2. group Id
      EG001
      num Affected
      125
      num At Risk
      388
      num Events
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      406
      num Events
      66
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      388
      num Events
      31
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      406
      num Events
      50
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      388
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      238
      num At Risk
      406
      num Events
      299
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      388
      num Events
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      21
      num Events
      5
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      6
      num Events
      4
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      406
      num Events
      141
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      388
      num Events
      58
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      406
      num Events
      75
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      388
      num Events
      34
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      116
      num At Risk
      406
      num Events
      142
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      388
      num Events
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      223
      num At Risk
      406
      num Events
      686
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      388
      num Events
      107
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      21
      num Events
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      6
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      406
      num Events
      51
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      388
      num Events
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dry mouth
Complete source fields
description
All-cause mortality was reported on all randomized participants. AEs were reported on participants who received atleast 1 dose of treatment. MedDRA preferred terms Neoplasm progression, Malignant neoplasm progression \& Disease progression not related to drug were excluded.
event Groups
  1. deaths Num Affected
    317
    deaths Num At Risk
    406
    description
    Participants with Endometrial cancer (EC) received lenvatinib 20 milligrams (mg) orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle. Participants continued to receive treatment until disease progression, development of unacceptable toxicity, withdrawal of consent, completion of 35 treatments (approximately 2 years) with pembrolizumab, or sponsor termination of the study
    id
    EG000
    other Num Affected
    404
    other Num At Risk
    406
    serious Num Affected
    237
    serious Num At Risk
    406
    title
    First Course: Lenvatinib + Pembrolizumab
  2. deaths Num Affected
    362
    deaths Num At Risk
    388
    description
    Participants with EC received either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle. Participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care, or until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination of the study.
    id
    EG001
    other Num Affected
    379
    other Num At Risk
    388
    serious Num Affected
    121
    serious Num At Risk
    388
    title
    First Course: TPC Doxorubicin or Paclitaxel
  3. deaths Num Affected
    8
    deaths Num At Risk
    21
    description
    Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) and lenvatinib (\~2years) or who had Stable disease (SD) or partial response (PR) or had attained complete response (CR), but experienced radiologic progression of disease (PD) initiated a second course of pembrolizumab and lenvatinib at investigators discretion at the same dose and schedule at lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle upto 17 cycles (upto \~1 year)
    id
    EG002
    other Num Affected
    20
    other Num At Risk
    21
    serious Num Affected
    4
    serious Num At Risk
    21
    title
    Second Course: Lenvatinib + Pembrolizumab
  4. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    Eligible participants who completed the first course of either doxorubicin 60 milligrams per square meter (mg/m\^2) intravenously, every 3 weeks, in each 21-day treatment cycle, or paclitaxel 80 mg/m\^2 intravenously, weekly (3 weeks on/1 week off), in each 28-day treatment cycle and eligible participants continued to receive treatment until a lifetime cumulative dose of 500 mg/m\^2 doxorubicin, a maximum dose of paclitaxel per standard of care or who had Stable disease (SD) or partial response (PR) or had attained complete response (CR), but experienced radiologic progression of disease (PD) initiated treatment with pembrolizumab and lenvatinib at investigators discretion at the same dose and schedule at lenvatinib 20 mg orally, once daily, plus pembrolizumab 200 mg intravenously, every 3 weeks in each 21-day cycle upto 17 cycles (upto \~1 year)
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    1
    serious Num At Risk
    6
    title
    TPC Crossover
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      115
      num At Risk
      406
      num Events
      171
    2. group Id
      EG001
      num Affected
      181
      num At Risk
      388
      num Events
      240
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      406
      num Events
      72
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      388
      num Events
      89
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      406
      num Events
      61
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      388
      num Events
      45
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      21
      num Events
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      406
      num Events
      106
    2. group Id
      EG001
      num Affected
      125
      num At Risk
      388
      num Events
      213
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      406
      num Events
      66
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      388
      num Events
      31
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      3
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      406
      num Events
      50
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      388
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      21
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      238
      num At Risk
      406
      num Events
      299
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      388
      num Events
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      21
      num Events
      5
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      6
      num Events
      4
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      406
      num Events
      141
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      388
      num Events
      58
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      406
      num Events
      75
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      388
      num Events
      34
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      21
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      116
      num At Risk
      406
      num Events
      142
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      388
      num Events
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      6
      num Events
      2
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      223
      num At Risk
      406
      num Events
      686
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      388
      num Events
      107
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      21
      num Events
      5
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      6
      num Events
      6
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      406
      num Events
      51
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      388
      num Events
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dry mouth
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
      num Events
      1
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      388
      num Events
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      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 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      406
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      406
      num Events
      2
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      388
      num Events
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      406
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Leukocytosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      406
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      388
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
      num Events
      1
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      388
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      406
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Neutrophilia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thrombotic microangiopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      406
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Acute coronary syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      406
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      21
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Acute myocardial infarction
time Frame
Up to approximately 79 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice