Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03675737 · ADVERSE EVENTS

Adverse events

Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Participants Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-859/KEYNOTE-859) · Source last updated 2026-02-27

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 49.3 months
Other-event reporting threshold
5%

All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)

Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).

358 / 785755 / 785689 / 790
Placebo + Chemotherapy (FP or CAPOX Regimen)

Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).

317 / 787751 / 787733 / 789
Pembrolizumab Second Course

Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule of 200 mg IV on Day 1 Q3W for up to 17 cycles (up to approximately 1 year).

1 / 1210 / 128 / 12

Group identifiers: EG000: Pembrolizumab + Chemotherapy (FP or CAPOX Regimen) · EG001: Placebo + Chemotherapy (FP or CAPOX Regimen) · 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 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      785
      num Events
      10
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      787
      num Events
      10
    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 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Aplastic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Blood loss anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Disseminated intravascular coagulation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      785
      num Events
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      787
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      785
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      787
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Immune thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      787
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Myelosuppression
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      787
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      785
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      787
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Thrombotic thrombocytopenic purpura

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      325
      num At Risk
      785
      num Events
      512
    2. group Id
      EG001
      num Affected
      282
      num At Risk
      787
      num Events
      413
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      785
      num Events
      76
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      787
      num Events
      79
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      3
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      785
      num Events
      38
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      787
      num Events
      25
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      146
      num At Risk
      785
      num Events
      309
    2. group Id
      EG001
      num Affected
      141
      num At Risk
      787
      num Events
      294
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      4
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      785
      num Events
      147
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      787
      num Events
      137
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      785
      num Events
      23
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      787
      num Events
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      785
      num Events
      44
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      787
      num Events
      15
    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 27.1
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      785
      num Events
      139
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      787
      num Events
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      785
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Erythema of eyelid
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      785
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Eye swelling
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      785
      num Events
      43
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      787
      num Events
      42
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      2
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      785
      num Events
      165
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      787
      num Events
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain
Complete source fields
description
All-cause mortality=all randomized participants and adverse events (AE)=all participants who received ≥1 dose of treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression, malignant neoplasm progression, and disease progression not related to treatment were excluded.
event Groups
  1. deaths Num Affected
    689
    deaths Num At Risk
    790
    description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5-fluorouracil (5FU) 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally twice a day (BID) on Days 1 to 14 Q3W (CAPOX regimen). Participants who completed up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), could have initiated a second course of pembrolizumab for up to 17 cycles (approximately 1 additional year).
    id
    EG000
    other Num Affected
    755
    other Num At Risk
    785
    serious Num Affected
    358
    serious Num At Risk
    785
    title
    Pembrolizumab + Chemotherapy (FP or CAPOX Regimen)
  2. deaths Num Affected
    733
    deaths Num At Risk
    789
    description
    Participants received placebo on Day 1 Q3W for up to 35 cycles (approximately 2 years) + physicians' choice of either cisplatin 80 mg/m\^2 IV on Day 1 Q3W and 5FU 800 mg/m\^2/day via continuous IV infusion on Days 1 to 5 Q3W (FP regimen) OR oxaliplatin 130 mg/m\^2 IV on Day 1 Q3W + capecitabine 1000 mg/m\^2 orally BID on Days 1 to 14 Q3W (CAPOX regimen).
    id
    EG001
    other Num Affected
    751
    other Num At Risk
    787
    serious Num Affected
    317
    serious Num At Risk
    787
    title
    Placebo + Chemotherapy (FP or CAPOX Regimen)
  3. deaths Num Affected
    8
    deaths Num At Risk
    12
    description
    Eligible participants who completed the first course of up to 35 administrations of pembrolizumab (approximately 2 years) or achieved a complete response (CR) but experienced progression of disease (PD), initiated a second course of pembrolizumab at the investigator's discretion, at the same dose and schedule of 200 mg IV on Day 1 Q3W for up to 17 cycles (up to approximately 1 year).
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    12
    serious Num Affected
    1
    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 27.1
    stats
    1. group Id
      EG000
      num Affected
      325
      num At Risk
      785
      num Events
      512
    2. group Id
      EG001
      num Affected
      282
      num At Risk
      787
      num Events
      413
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
      num Events
      4
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      785
      num Events
      76
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      787
      num Events
      79
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      3
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      785
      num Events
      38
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      787
      num Events
      25
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      12
      num Events
      3
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      146
      num At Risk
      785
      num Events
      309
    2. group Id
      EG001
      num Affected
      141
      num At Risk
      787
      num Events
      294
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      4
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      785
      num Events
      147
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      787
      num Events
      137
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      12
      num Events
      2
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      785
      num Events
      23
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      787
      num Events
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      785
      num Events
      44
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      787
      num Events
      15
    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 27.1
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      785
      num Events
      139
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      787
      num Events
      40
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      785
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Erythema of eyelid
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      785
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      1
    term
    Eye swelling
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      785
      num Events
      43
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      787
      num Events
      42
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      12
      num Events
      2
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      130
      num At Risk
      785
      num Events
      165
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      787
      num Events
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Abdominal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      785
      num Events
      10
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      787
      num Events
      10
    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 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Aplastic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Blood loss anaemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Disseminated intravascular coagulation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      785
      num Events
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      787
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      785
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      787
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Immune thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      787
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Myelosuppression
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      787
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      785
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      787
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      785
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      787
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      12
      num Events
      0
    term
    Thrombotic thrombocytopenic purpura
time Frame
Up to approximately 49.3 months

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

Preserved source evidence · Not medical advice