Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03615326 · ADVERSE EVENTS

Adverse events

Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811) · Source last updated 2026-08-26

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 63 months
Other-event reporting threshold
5%

All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Global Pembrolizumab + Standard of Care First Course

Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.

163 / 350345 / 350264 / 350
Global Standard of Care

Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.

159 / 346338 / 346288 / 348
Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin

Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.

10 / 2020 / 2014 / 20
Japan Trastuzumab + S-1 Plus Oxaliplatin

Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.

9 / 2020 / 2017 / 20
Global Pembrolizumab + Standard of Care Second Course

Eligible participants from the Global Cohort Pembrolizumab + Standard of Care who stopped initial course of pembrolizumab due to complete response (CR) or who had stable disease (SD), PR, or CR after completion of 35 cycles of pembrolizumab but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion. Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 17 additional cycles (approximately 1 year additional treatment).

0 / 119 / 113 / 11

Group identifiers: EG000: Global Pembrolizumab + Standard of Care First Course · EG001: Global Standard of Care · EG002: Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin · EG003: Japan Trastuzumab + S-1 Plus Oxaliplatin · EG004: Global Pembrolizumab + Standard of Care Second Course

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 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      350
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      346
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      346
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Granulocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      350
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Iron deficiency anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      350
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      346
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      346
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      346
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      350
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      346
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Angina pectoris
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Arrhythmia

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 26.1
    stats
    1. group Id
      EG000
      num Affected
      157
      num At Risk
      350
      num Events
      269
    2. group Id
      EG001
      num Affected
      159
      num At Risk
      346
      num Events
      257
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      20
      num Events
      6
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      20
      num Events
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      11
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      350
      num Events
      26
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      346
      num Events
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      350
      num Events
      133
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      346
      num Events
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      350
      num Events
      67
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      346
      num Events
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      350
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Hypopituitarism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      350
      num Events
      42
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      346
      num Events
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      350
      num Events
      48
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      346
      num Events
      63
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      350
      num Events
      25
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      346
      num Events
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      350
      num Events
      80
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      346
      num Events
      81
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      20
      num Events
      8
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      20
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      177
      num At Risk
      350
      num Events
      330
    2. group Id
      EG001
      num Affected
      152
      num At Risk
      346
      num Events
      295
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      20
      num Events
      30
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      20
      num Events
      25
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      350
      num Events
      27
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      346
      num Events
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      350
      num Events
      31
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      346
      num Events
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Dysphagia
Complete source fields
description
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. Per protocol, All Cause Mortality and AEs were reported separately for Global Pembrolizumab + SOC and Global Pembrolizumab + SOC Second Course arms.
event Groups
  1. deaths Num Affected
    264
    deaths Num At Risk
    350
    description
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    id
    EG000
    other Num Affected
    345
    other Num At Risk
    350
    serious Num Affected
    163
    serious Num At Risk
    350
    title
    Global Pembrolizumab + Standard of Care First Course
  2. deaths Num Affected
    288
    deaths Num At Risk
    348
    description
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with FP or CAPOX chemotherapy.
    id
    EG001
    other Num Affected
    338
    other Num At Risk
    346
    serious Num Affected
    159
    serious Num At Risk
    346
    title
    Global Standard of Care
  3. deaths Num Affected
    14
    deaths Num At Risk
    20
    description
    Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) plus trastuzumab (8 mg/kg loading dose, 6 mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
    id
    EG002
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    10
    serious Num At Risk
    20
    title
    Japan Pembrolizumab + Trastuzumab + S-1 Plus Oxaliplatin
  4. deaths Num Affected
    17
    deaths Num At Risk
    20
    description
    Participants received matched placebo to pembrolizumab IV Q3W plus trastuzumab (8mg/kg loading dose, 6mg/kg maintenance thereafter) IV Q3W in combination with SOX chemotherapy.
    id
    EG003
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    9
    serious Num At Risk
    20
    title
    Japan Trastuzumab + S-1 Plus Oxaliplatin
  5. deaths Num Affected
    3
    deaths Num At Risk
    11
    description
    Eligible participants from the Global Cohort Pembrolizumab + Standard of Care who stopped initial course of pembrolizumab due to complete response (CR) or who had stable disease (SD), PR, or CR after completion of 35 cycles of pembrolizumab but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion. Participants received 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 17 additional cycles (approximately 1 year additional treatment).
    id
    EG004
    other Num Affected
    9
    other Num At Risk
    11
    serious Num Affected
    0
    serious Num At Risk
    11
    title
    Global Pembrolizumab + Standard of Care Second Course
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      157
      num At Risk
      350
      num Events
      269
    2. group Id
      EG001
      num Affected
      159
      num At Risk
      346
      num Events
      257
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      20
      num Events
      6
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      20
      num Events
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      11
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      350
      num Events
      26
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      346
      num Events
      46
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      350
      num Events
      133
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      346
      num Events
      111
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      350
      num Events
      67
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      346
      num Events
      71
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      350
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Hypopituitarism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      350
      num Events
      42
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      346
      num Events
      22
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      350
      num Events
      48
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      346
      num Events
      63
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      20
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      350
      num Events
      25
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      346
      num Events
      30
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      350
      num Events
      80
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      346
      num Events
      81
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      20
      num Events
      8
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      20
      num Events
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      177
      num At Risk
      350
      num Events
      330
    2. group Id
      EG001
      num Affected
      152
      num At Risk
      346
      num Events
      295
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      20
      num Events
      30
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      20
      num Events
      25
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      350
      num Events
      27
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      346
      num Events
      17
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      350
      num Events
      31
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      346
      num Events
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      11
      num Events
      1
    term
    Dysphagia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      350
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      346
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      20
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Disseminated intravascular coagulation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      346
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Granulocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      350
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Iron deficiency anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      350
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      346
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Neutropenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      346
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      346
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      20
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      350
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      346
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Angina pectoris
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      350
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      346
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      20
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      20
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      11
      num Events
      0
    term
    Arrhythmia
time Frame
Up to 63 months

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

Preserved source evidence · Not medical advice