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NCT03434379 · ADVERSE EVENTS

Adverse events

A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma · Source last updated 2023-10-23

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 end of study (up to approximately 56 months)
Other-event reporting threshold
5%

All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Sorafenib - Global

Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

51 / 156147 / 156115 / 165
Atezolizumab + Bevacizumab - Global

Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

171 / 329311 / 329228 / 336
Sorafenib - China

Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

12 / 5855 / 5846 / 61
Atezolizumab + Bevacizumab - China

Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

54 / 132129 / 13288 / 133

Group identifiers: EG000: Sorafenib - Global · EG001: Atezolizumab + Bevacizumab - Global · EG002: Sorafenib - China · EG003: Atezolizumab + Bevacizumab - China

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      156
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      329
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      132
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Immune thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      156
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      329
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      132
      num Events
      3
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      329
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      329
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      132
      num Events
      2
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Hydrocele
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Hypoacusis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Addison's disease

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      156
      num Events
      15
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      329
      num Events
      56
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      58
      num Events
      9
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      132
      num Events
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      156
      num Events
      6
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      329
      num Events
      33
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
      num Events
      6
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      132
      num Events
      32
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      156
      num Events
      7
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      329
      num Events
      28
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
      num Events
      6
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      132
      num Events
      20
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      156
      num Events
      9
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      329
      num Events
      45
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      58
      num Events
      5
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      132
      num Events
      41
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      156
      num Events
      3
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      329
      num Events
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      132
      num Events
      19
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      156
      num Events
      5
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      329
      num Events
      27
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
      num Events
      4
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      132
      num Events
      17
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      156
      num Events
      31
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      329
      num Events
      63
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      58
      num Events
      15
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      132
      num Events
      24
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      156
      num Events
      10
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      329
      num Events
      30
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
      num Events
      4
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      132
      num Events
      8
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      156
      num Events
      10
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      329
      num Events
      36
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
      num Events
      3
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      132
      num Events
      10
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      156
      num Events
      27
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      329
      num Events
      63
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      58
      num Events
      5
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      132
      num Events
      20
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      156
      num Events
      107
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      329
      num Events
      109
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      58
      num Events
      38
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      132
      num Events
      28
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      156
      num Events
      28
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      329
      num Events
      64
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      58
      num Events
      9
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      132
      num Events
      22
    term
    Nausea
Complete source fields
description
All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.
event Groups
  1. deaths Num Affected
    115
    deaths Num At Risk
    165
    description
    Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    EG000
    other Num Affected
    147
    other Num At Risk
    156
    serious Num Affected
    51
    serious Num At Risk
    156
    title
    Sorafenib - Global
  2. deaths Num Affected
    228
    deaths Num At Risk
    336
    description
    Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    EG001
    other Num Affected
    311
    other Num At Risk
    329
    serious Num Affected
    171
    serious Num At Risk
    329
    title
    Atezolizumab + Bevacizumab - Global
  3. deaths Num Affected
    46
    deaths Num At Risk
    61
    description
    Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    EG002
    other Num Affected
    55
    other Num At Risk
    58
    serious Num Affected
    12
    serious Num At Risk
    58
    title
    Sorafenib - China
  4. deaths Num Affected
    88
    deaths Num At Risk
    133
    description
    Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
    id
    EG003
    other Num Affected
    129
    other Num At Risk
    132
    serious Num Affected
    54
    serious Num At Risk
    132
    title
    Atezolizumab + Bevacizumab - China
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      156
      num Events
      15
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      329
      num Events
      56
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      58
      num Events
      9
    4. group Id
      EG003
      num Affected
      26
      num At Risk
      132
      num Events
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      156
      num Events
      6
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      329
      num Events
      33
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
      num Events
      6
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      132
      num Events
      32
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      156
      num Events
      7
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      329
      num Events
      28
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      58
      num Events
      6
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      132
      num Events
      20
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      156
      num Events
      9
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      329
      num Events
      45
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      58
      num Events
      5
    4. group Id
      EG003
      num Affected
      22
      num At Risk
      132
      num Events
      41
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      156
      num Events
      3
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      329
      num Events
      41
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      132
      num Events
      19
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      156
      num Events
      5
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      329
      num Events
      27
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
      num Events
      4
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      132
      num Events
      17
    term
    Abdominal distension
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      156
      num Events
      31
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      329
      num Events
      63
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      58
      num Events
      15
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      132
      num Events
      24
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      156
      num Events
      10
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      329
      num Events
      30
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      58
      num Events
      4
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      132
      num Events
      8
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      156
      num Events
      10
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      329
      num Events
      36
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
      num Events
      3
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      132
      num Events
      10
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      156
      num Events
      27
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      329
      num Events
      63
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      58
      num Events
      5
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      132
      num Events
      20
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      156
      num Events
      107
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      329
      num Events
      109
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      58
      num Events
      38
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      132
      num Events
      28
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      156
      num Events
      28
    2. group Id
      EG001
      num Affected
      49
      num At Risk
      329
      num Events
      64
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      58
      num Events
      9
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      132
      num Events
      22
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      156
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      329
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      58
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      132
      num Events
      3
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Immune thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      156
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      329
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      58
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      132
      num Events
      3
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Acute coronary syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      329
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Acute myocardial infarction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Cardiac arrest
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      156
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Cardiac failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      329
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      132
      num Events
      2
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Hydrocele
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      132
      num Events
      1
    term
    Hypoacusis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      156
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      329
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      58
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      132
      num Events
      0
    term
    Addison's disease
time Frame
Up to end of study (up to approximately 56 months)

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Preserved source evidence · Not medical advice