Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02256436 · ADVERSE EVENTS

Adverse events

A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045) · Source last updated 2021-09-20

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
Through end of trial analysis database cut-off date of 01-Oct-2020 (Up to approximately 71 months)
Other-event reporting threshold
5%

All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. Thirteen participants randomized to receive Control were switched over to pembrolizumab per protocol and were monitored for AEs separately.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Control

Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).

104 / 255237 / 255230 / 272
Pembrolizumab

Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).

107 / 266236 / 266224 / 270
Control Switched Over to Pembrolizumab

Per protocol, participants originally randomized to the Control arm that experienced disease progression were switched over to receive pembrolizumab 200 mg IV on Day 1 Q3W.

8 / 1311 / 139 / 13

Group identifiers: EG000: Control · EG001: Pembrolizumab · EG002: Control Switched Over to Pembrolizumab

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      255
      num Events
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      266
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      255
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anaemia of malignant disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      255
      num Events
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      255
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      255
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Nephrogenic anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      255
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      255
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Normocytic anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      255
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      255
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      255
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Acute coronary syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      255
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      255
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Atrial flutter

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      86
      num At Risk
      255
      num Events
      139
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      266
      num Events
      61
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      255
      num Events
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      255
      num Events
      0
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      266
      num Events
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      255
      num Events
      3
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      266
      num Events
      24
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      255
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      266
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      255
      num Events
      40
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      266
      num Events
      37
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      255
      num Events
      16
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      266
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      255
      num Events
      105
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      266
      num Events
      63
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      255
      num Events
      69
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      266
      num Events
      72
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      255
      num Events
      100
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      266
      num Events
      62
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      255
      num Events
      35
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      266
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      255
      num Events
      47
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      266
      num Events
      47
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Vomiting
Complete source fields
description
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug excluded as AEs. Thirteen participants randomized to receive Control were switched over to pembrolizumab per protocol and were monitored for AEs separately.
event Groups
  1. deaths Num Affected
    230
    deaths Num At Risk
    272
    description
    Participants received paclitaxel 175 mg/m\^2 intravenously (IV) or docetaxel 75 mg/m\^2 IV or vinflunine 320 mg/m\^2 IV, on Day 1 of each 3-week cycle (Q3W). Eligible participants who experienced disease progression may have been able to switch over to receive pembrolizumab 200 mg IV Q3W for up to 35 treatment administrations (up to approximately 2 years).
    id
    EG000
    other Num Affected
    237
    other Num At Risk
    255
    serious Num Affected
    104
    serious Num At Risk
    255
    title
    Control
  2. deaths Num Affected
    224
    deaths Num At Risk
    270
    description
    Participants received pembrolizumab 200 mg IV on Day 1 Q3W. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg IV Q3W for up to 17 cycles (up to approximately 1 additional year).
    id
    EG001
    other Num Affected
    236
    other Num At Risk
    266
    serious Num Affected
    107
    serious Num At Risk
    266
    title
    Pembrolizumab
  3. deaths Num Affected
    9
    deaths Num At Risk
    13
    description
    Per protocol, participants originally randomized to the Control arm that experienced disease progression were switched over to receive pembrolizumab 200 mg IV on Day 1 Q3W.
    id
    EG002
    other Num Affected
    11
    other Num At Risk
    13
    serious Num Affected
    8
    serious Num At Risk
    13
    title
    Control Switched Over to Pembrolizumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      86
      num At Risk
      255
      num Events
      139
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      266
      num Events
      61
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      255
      num Events
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      255
      num Events
      0
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      266
      num Events
      11
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      255
      num Events
      3
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      266
      num Events
      24
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      255
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      266
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Cataract
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      255
      num Events
      40
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      266
      num Events
      37
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      255
      num Events
      16
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      266
      num Events
      11
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      255
      num Events
      105
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      266
      num Events
      63
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      255
      num Events
      69
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      266
      num Events
      72
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      13
      num Events
      2
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      255
      num Events
      100
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      266
      num Events
      62
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      255
      num Events
      35
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      266
      num Events
      8
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      255
      num Events
      47
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      266
      num Events
      47
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Vomiting
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      255
      num Events
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      266
      num Events
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      255
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Anaemia of malignant disease
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      255
      num Events
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      255
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      255
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Nephrogenic anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      255
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      255
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Normocytic anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      255
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      255
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      255
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Acute coronary syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      255
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      266
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      255
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      266
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Atrial flutter
time Frame
Through end of trial analysis database cut-off date of 01-Oct-2020 (Up to approximately 71 months)

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

Preserved source evidence · Not medical advice