Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02367781 · ADVERSE EVENTS

Adverse events

A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2021-08-09

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
From the first study drug to the data cutoff date: 18 January 2021 (approximately 69 months)
Other-event reporting threshold
5%

The safety-evaluable population included all treated participants, defined as randomized participants who received any protocol treatment. For the safety analyses, participants were grouped according to whether any full or partial dose of atezolizumab was received, including when atezolizumab was received in error. Specifically, for participants randomized to the CnP arm, if atezolizumab was received in error, the participants were grouped to the Atezo+CnP arm for the safety analyses.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)

Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.

252 / 473467 / 473338 / 473
Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin)

Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression. This Arm B group includes participants who did not crossover to receive atezolizumab as monotherapy.

63 / 131127 / 131108 / 131
Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy)

Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression. This Arm B group includes participants who crossed over to receive atezolizumab as monotherapy.

24 / 101100 / 10170 / 101

Group identifiers: EG000: Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) · EG001: Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin) · EG002: Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy)

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 version 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      473
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    AGRANULOCYTOSIS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      473
      num Events
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      131
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      101
      num Events
      4
    term
    ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      473
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      131
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      101
      num Events
      2
    term
    FEBRILE NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      473
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    HAEMOLYTIC URAEMIC SYNDROME
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      473
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    LEUKOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      473
      num Events
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    NEUTROPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      473
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    PANCYTOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      473
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    THROMBOCYTOPENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      473
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    ACUTE CORONARY SYNDROME
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      473
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    ACUTE MYOCARDIAL INFARCTION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      473
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    ANGINA UNSTABLE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      473
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    ATRIAL FIBRILLATION

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 version 23.1
    stats
    1. group Id
      EG000
      num Affected
      259
      num At Risk
      473
      num Events
      357
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      131
      num Events
      79
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      101
      num Events
      55
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      473
      num Events
      92
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      131
      num Events
      22
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      101
      num Events
      7
    term
    LEUKOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      213
      num At Risk
      473
      num Events
      424
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      131
      num Events
      95
    3. group Id
      EG002
      num Affected
      53
      num At Risk
      101
      num Events
      99
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      132
      num At Risk
      473
      num Events
      210
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      131
      num Events
      49
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      101
      num Events
      47
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      473
      num Events
      55
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    HYPOTHYROIDISM
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      473
      num Events
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      131
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      101
      num Events
      4
    term
    VISION BLURRED
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      473
      num Events
      67
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      131
      num Events
      11
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      101
      num Events
      9
    term
    ABDOMINAL PAIN
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      473
      num Events
      33
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      131
      num Events
      7
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      101
      num Events
      7
    term
    ABDOMINAL PAIN UPPER
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      176
      num At Risk
      473
      num Events
      224
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      131
      num Events
      47
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      101
      num Events
      42
    term
    CONSTIPATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      196
      num At Risk
      473
      num Events
      321
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      131
      num Events
      61
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      101
      num Events
      41
    term
    DIARRHOEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      473
      num Events
      24
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      131
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      101
      num Events
      2
    term
    DRY MOUTH
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      473
      num Events
      34
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      131
      num Events
      2
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      101
      num Events
      6
    term
    DYSPEPSIA
Complete source fields
description
The safety-evaluable population included all treated participants, defined as randomized participants who received any protocol treatment. For the safety analyses, participants were grouped according to whether any full or partial dose of atezolizumab was received, including when atezolizumab was received in error. Specifically, for participants randomized to the CnP arm, if atezolizumab was received in error, the participants were grouped to the Atezo+CnP arm for the safety analyses.
event Groups
  1. deaths Num Affected
    338
    deaths Num At Risk
    473
    description
    Participants received intravenous (IV) infusion of atezolizumab and carboplatin on Day 1 of each 21-day cycle, and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first during induction treatment phase. Participants received IV infusion of atezolizumab during maintenance treatment phase until loss of clinical benefit.
    id
    EG000
    other Num Affected
    467
    other Num At Risk
    473
    serious Num Affected
    252
    serious Num At Risk
    473
    title
    Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin)
  2. deaths Num Affected
    108
    deaths Num At Risk
    131
    description
    Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression. This Arm B group includes participants who did not crossover to receive atezolizumab as monotherapy.
    id
    EG001
    other Num Affected
    127
    other Num At Risk
    131
    serious Num Affected
    63
    serious Num At Risk
    131
    title
    Arm B Without Crossover Participants (Nab-Paclitaxel+Carboplatin)
  3. deaths Num Affected
    70
    deaths Num At Risk
    101
    description
    Participants received IV infusion of carboplatin on Day 1 and nab-paclitaxel on Days 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression whichever occurs first during induction treatment phase. Participants received best supportive care during maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. Participants who were consented prior to approval of protocol Version 5 were given the option to cross over to receive atezolizumab as monotherapy until disease progression. This Arm B group includes participants who crossed over to receive atezolizumab as monotherapy.
    id
    EG002
    other Num Affected
    100
    other Num At Risk
    101
    serious Num Affected
    24
    serious Num At Risk
    101
    title
    Arm B With Crossover Participants (Nab-Paclitaxel+Carboplatin, After Crossover Atezo Monotherapy)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      259
      num At Risk
      473
      num Events
      357
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      131
      num Events
      79
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      101
      num Events
      55
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      473
      num Events
      92
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      131
      num Events
      22
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      101
      num Events
      7
    term
    LEUKOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      213
      num At Risk
      473
      num Events
      424
    2. group Id
      EG001
      num Affected
      52
      num At Risk
      131
      num Events
      95
    3. group Id
      EG002
      num Affected
      53
      num At Risk
      101
      num Events
      99
    term
    NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      132
      num At Risk
      473
      num Events
      210
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      131
      num Events
      49
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      101
      num Events
      47
    term
    THROMBOCYTOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      473
      num Events
      55
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    HYPOTHYROIDISM
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      473
      num Events
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      131
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      101
      num Events
      4
    term
    VISION BLURRED
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      473
      num Events
      67
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      131
      num Events
      11
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      101
      num Events
      9
    term
    ABDOMINAL PAIN
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      473
      num Events
      33
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      131
      num Events
      7
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      101
      num Events
      7
    term
    ABDOMINAL PAIN UPPER
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      176
      num At Risk
      473
      num Events
      224
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      131
      num Events
      47
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      101
      num Events
      42
    term
    CONSTIPATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      196
      num At Risk
      473
      num Events
      321
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      131
      num Events
      61
    3. group Id
      EG002
      num Affected
      35
      num At Risk
      101
      num Events
      41
    term
    DIARRHOEA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      473
      num Events
      24
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      131
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      101
      num Events
      2
    term
    DRY MOUTH
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      473
      num Events
      34
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      131
      num Events
      2
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      101
      num Events
      6
    term
    DYSPEPSIA
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      473
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    AGRANULOCYTOSIS
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      473
      num Events
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      131
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      101
      num Events
      4
    term
    ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      473
      num Events
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      131
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      101
      num Events
      2
    term
    FEBRILE NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      473
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    HAEMOLYTIC URAEMIC SYNDROME
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      473
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    LEUKOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      473
      num Events
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      101
      num Events
      1
    term
    NEUTROPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      473
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    PANCYTOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      473
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    THROMBOCYTOPENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      473
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    ACUTE CORONARY SYNDROME
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      473
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    ACUTE MYOCARDIAL INFARCTION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      473
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      131
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    ANGINA UNSTABLE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      473
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      131
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      101
      num Events
      0
    term
    ATRIAL FIBRILLATION
time Frame
From the first study drug to the data cutoff date: 18 January 2021 (approximately 69 months)

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

Preserved source evidence · Not medical advice