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NCT03635567 · ADVERSE EVENTS

Adverse events

Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826) · Source last updated 2026-02-04

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

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

Collection time frame
Up to approximately 66 months
Other-event reporting threshold
5%

Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pembrolizumab+Chemotherapy

On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.

157 / 307298 / 307195 / 308
Placebo+Chemotherapy

On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.

132 / 309299 / 309241 / 309
Pembrolizumab (Second Course)

Eligible participants received up to 17 additional administrations (up to approximately 1 year) of pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.

4 / 128 / 124 / 12

Group identifiers: EG000: Pembrolizumab+Chemotherapy · EG001: Placebo+Chemotherapy · EG002: Pembrolizumab (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 27.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      307
      num Events
      14
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      309
      num Events
      14
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Bicytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      307
      num Events
      25
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      309
      num Events
      14
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Lymphadenitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      307
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      309
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      307
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      309
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      307
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      309
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      307
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      309
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Bundle branch block
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      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 27.0
    stats
    1. group Id
      EG000
      num Affected
      182
      num At Risk
      307
      num Events
      264
    2. group Id
      EG001
      num Affected
      159
      num At Risk
      309
      num Events
      247
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      307
      num Events
      71
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      309
      num Events
      55
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      307
      num Events
      29
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      309
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      307
      num Events
      142
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      309
      num Events
      115
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      307
      num Events
      90
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      309
      num Events
      101
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      307
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      309
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Ear discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      307
      num Events
      26
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      309
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Hyperthyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      307
      num Events
      65
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      309
      num Events
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      307
      num Events
      66
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      309
      num Events
      78
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      307
      num Events
      18
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      309
      num Events
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain lower
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      307
      num Events
      43
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      309
      num Events
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Cheilitis
Complete source fields
description
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
event Groups
  1. deaths Num Affected
    195
    deaths Num At Risk
    308
    description
    On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    EG000
    other Num Affected
    298
    other Num At Risk
    307
    serious Num Affected
    157
    serious Num At Risk
    307
    title
    Pembrolizumab+Chemotherapy
  2. deaths Num Affected
    241
    deaths Num At Risk
    309
    description
    On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.
    id
    EG001
    other Num Affected
    299
    other Num At Risk
    309
    serious Num Affected
    132
    serious Num At Risk
    309
    title
    Placebo+Chemotherapy
  3. deaths Num Affected
    4
    deaths Num At Risk
    12
    description
    Eligible participants received up to 17 additional administrations (up to approximately 1 year) of pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
    id
    EG002
    other Num Affected
    8
    other Num At Risk
    12
    serious Num Affected
    4
    serious Num At Risk
    12
    title
    Pembrolizumab (Second Course)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      182
      num At Risk
      307
      num Events
      264
    2. group Id
      EG001
      num Affected
      159
      num At Risk
      309
      num Events
      247
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      307
      num Events
      71
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      309
      num Events
      55
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      307
      num Events
      29
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      309
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      307
      num Events
      142
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      309
      num Events
      115
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      307
      num Events
      90
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      309
      num Events
      101
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      307
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      309
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Ear discomfort
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      307
      num Events
      26
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      309
      num Events
      10
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Hyperthyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      307
      num Events
      65
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      309
      num Events
      33
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      307
      num Events
      66
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      309
      num Events
      78
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      307
      num Events
      18
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      309
      num Events
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain lower
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      307
      num Events
      43
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      309
      num Events
      41
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Cheilitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      307
      num Events
      14
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      309
      num Events
      14
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Bicytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      307
      num Events
      25
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      309
      num Events
      14
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Lymphadenitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      307
      num Events
      5
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      309
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      307
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      309
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      307
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      309
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      307
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      309
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Bundle branch block
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      307
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      309
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Cardiac arrest
time Frame
Up to approximately 66 months

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Preserved source evidence · Not medical advice