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NCT02494583 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062) · Source last updated 2023-04-13

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 months
Other-event reporting threshold
5%

All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pembrolizumab Monotherapy (Pembro Mono) First Course

Participants received pembrolizumab 200 mg IV Q3W.

93 / 254216 / 254229 / 256
Pembrolizumab + SOC Chemotherapy (Pembro Combo)-First Course

Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.

122 / 250239 / 250232 / 257
Placebo + SOC Chemotherapy (SOC)-First Course

Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.

117 / 244234 / 244240 / 250
Pembrolizumab Monotherapy Second Course

Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).

1 / 43 / 42 / 4
Pembrolizumab + SOC Chemotherapy-Second Course

Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) administered in combination with SOC chemotherapy, and experienced Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).

0 / 55 / 51 / 5

Group identifiers: EG000: Pembrolizumab Monotherapy (Pembro Mono) First Course · EG001: Pembrolizumab + SOC Chemotherapy (Pembro Combo)-First Course · EG002: Placebo + SOC Chemotherapy (SOC)-First Course · EG003: Pembrolizumab Monotherapy Second Course · EG004: Pembrolizumab + SOC Chemotherapy-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 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      254
      num Events
      3
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      250
      num Events
      14
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      244
      num Events
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      250
      num Events
      9
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      244
      num Events
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      250
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Hypochromic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      250
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Iron deficiency anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      250
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      250
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      250
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      244
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      250
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      250
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      250
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      250
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      250
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Cardiac arrest

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 25.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      254
      num Events
      73
    2. group Id
      EG001
      num Affected
      112
      num At Risk
      250
      num Events
      150
    3. group Id
      EG002
      num Affected
      108
      num At Risk
      244
      num Events
      144
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      4
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      250
      num Events
      52
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      244
      num Events
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
      num Events
      2
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      250
      num Events
      201
    3. group Id
      EG002
      num Affected
      102
      num At Risk
      244
      num Events
      222
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      254
      num Events
      5
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      250
      num Events
      38
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      244
      num Events
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      250
      num Events
      24
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      244
      num Events
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      254
      num Events
      21
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      250
      num Events
      29
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      244
      num Events
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      254
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      250
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      244
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      254
      num Events
      21
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      250
      num Events
      11
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      244
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      254
      num Events
      56
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      250
      num Events
      49
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      244
      num Events
      54
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      254
      num Events
      26
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      250
      num Events
      27
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      244
      num Events
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      254
      num Events
      7
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      250
      num Events
      8
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      244
      num Events
      15
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      254
      num Events
      43
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      250
      num Events
      108
    3. group Id
      EG002
      num Affected
      68
      num At Risk
      244
      num Events
      83
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Constipation
Complete source fields
description
All-Cause Mortality reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
event Groups
  1. deaths Num Affected
    229
    deaths Num At Risk
    256
    description
    Participants received pembrolizumab 200 mg IV Q3W.
    id
    EG000
    other Num Affected
    216
    other Num At Risk
    254
    serious Num Affected
    93
    serious Num At Risk
    254
    title
    Pembrolizumab Monotherapy (Pembro Mono) First Course
  2. deaths Num Affected
    232
    deaths Num At Risk
    257
    description
    Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
    id
    EG001
    other Num Affected
    239
    other Num At Risk
    250
    serious Num Affected
    122
    serious Num At Risk
    250
    title
    Pembrolizumab + SOC Chemotherapy (Pembro Combo)-First Course
  3. deaths Num Affected
    240
    deaths Num At Risk
    250
    description
    Participants received placebo IV Q3W plus cisplatin 80 mg/m\^2 Q3W plus 5-FU 800 mg/m\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.
    id
    EG002
    other Num Affected
    234
    other Num At Risk
    244
    serious Num Affected
    117
    serious Num At Risk
    244
    title
    Placebo + SOC Chemotherapy (SOC)-First Course
  4. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) with Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Pembrolizumab Monotherapy Second Course
  5. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    Eligible participants who stopped the initial course of pembrolizumab (200 mg IV Q3W for up to 35 treatments \[approximately 2 years\]) administered in combination with SOC chemotherapy, and experienced Stable Disease (SD) or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (up to approximately 1 additional year).
    id
    EG004
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    0
    serious Num At Risk
    5
    title
    Pembrolizumab + SOC Chemotherapy-Second Course
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      254
      num Events
      73
    2. group Id
      EG001
      num Affected
      112
      num At Risk
      250
      num Events
      150
    3. group Id
      EG002
      num Affected
      108
      num At Risk
      244
      num Events
      144
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      4
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      250
      num Events
      52
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      244
      num Events
      51
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
      num Events
      2
    2. group Id
      EG001
      num Affected
      95
      num At Risk
      250
      num Events
      201
    3. group Id
      EG002
      num Affected
      102
      num At Risk
      244
      num Events
      222
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      254
      num Events
      5
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      250
      num Events
      38
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      244
      num Events
      33
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      250
      num Events
      24
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      244
      num Events
      20
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      254
      num Events
      21
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      250
      num Events
      29
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      244
      num Events
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      254
      num Events
      2
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      250
      num Events
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      244
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal discomfort
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      254
      num Events
      21
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      250
      num Events
      11
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      244
      num Events
      10
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal distension
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      254
      num Events
      56
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      250
      num Events
      49
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      244
      num Events
      54
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      254
      num Events
      26
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      250
      num Events
      27
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      244
      num Events
      25
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      254
      num Events
      7
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      250
      num Events
      8
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      244
      num Events
      15
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Ascites
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      254
      num Events
      43
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      250
      num Events
      108
    3. group Id
      EG002
      num Affected
      68
      num At Risk
      244
      num Events
      83
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      254
      num Events
      3
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      250
      num Events
      14
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      244
      num Events
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      250
      num Events
      9
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      244
      num Events
      8
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      250
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Hypochromic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      250
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Iron deficiency anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      250
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      250
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      250
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      244
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      250
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      250
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Arrhythmia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      250
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      254
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      250
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      254
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      250
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      244
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Cardiac arrest
time Frame
Up to approximately 78 months

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Preserved source evidence · Not medical advice