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NCT03298451 · ADVERSE EVENTS

Adverse events

Study of Durvalumab and Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma · Source last updated 2026-07-27

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

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

Collection time frame
All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).
Other-event reporting threshold
5%

TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Durva 1500 mg

Durvalumab 1500 mg every 4 weeks (Q4W)

115 / 388299 / 388280 / 389
Treme 300 mg x1 Dose + Durva 1500 mg

Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W

157 / 388334 / 388262 / 393
Treme 75 mg x4 Doses + Durva 1500 mg

Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W

52 / 152133 / 152123 / 153
Sora 400 mg

Sorafenib 400 mg twice daily (BID)

111 / 374333 / 374293 / 389

Group identifiers: EG000: Durva 1500 mg · EG001: Treme 300 mg x1 Dose + Durva 1500 mg · EG002: Treme 75 mg x4 Doses + Durva 1500 mg · EG003: Sora 400 mg

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
    Immune system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      152
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Haemophagocytic lymphohistiocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Device related infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Enterocolitis infectious
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      388
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Gastroenteritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      374
      num Events
      1
    term
    Hepatitis c
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      374
      num Events
      1
    term
    Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Lower respiratory tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      374
      num Events
      1
    term
    Meningitis listeria
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Necrotising fasciitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      388
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      152
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      374
      num Events
      1
    term
    Peritonitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      388
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Pneumocystis jirovecii pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      388
      num Events
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      388
      num Events
      7
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      152
      num Events
      6
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      374
      num Events
      8
    term
    Pneumonia

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
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      388
      num Events
      49
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      388
      num Events
      45
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      152
      num Events
      9
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      374
      num Events
      26
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      388
      num Events
      11
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      388
      num Events
      38
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      152
      num Events
      6
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      374
      num Events
      17
    term
    Amylase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      388
      num Events
      63
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      388
      num Events
      53
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      152
      num Events
      17
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      374
      num Events
      33
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      388
      num Events
      30
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      388
      num Events
      23
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      152
      num Events
      5
    4. group Id
      EG003
      num Affected
      29
      num At Risk
      374
      num Events
      32
    term
    Blood bilirubin increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      388
      num Events
      12
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      388
      num Events
      18
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      152
      num Events
      7
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      374
      num Events
      24
    term
    Gamma-glutamyltransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      388
      num Events
      27
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      388
      num Events
      38
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      152
      num Events
      10
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      374
      num Events
      17
    term
    Lipase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      388
      num Events
      58
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      388
      num Events
      69
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      152
      num Events
      24
    4. group Id
      EG003
      num Affected
      67
      num At Risk
      374
      num Events
      72
    term
    Decreased appetite
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      388
      num Events
      35
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      388
      num Events
      35
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      152
      num Events
      11
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      374
      num Events
      13
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      388
      num Events
      29
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      388
      num Events
      39
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      152
      num Events
      15
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      374
      num Events
      32
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      388
      num Events
      4
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      388
      num Events
      11
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      152
      num Events
      12
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      374
      num Events
      14
    term
    Pain in extremity
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      388
      num Events
      21
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      388
      num Events
      44
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      152
      num Events
      10
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      374
      num Events
      16
    term
    Insomnia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      388
      num Events
      9
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      388
      num Events
      31
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      152
      num Events
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      374
      num Events
      2
    term
    Hyperthyroidism
Complete source fields
description
TEAE was defined as any AE that started after dosing or prior to dosing and worsens following treatment exposure. AE was observed up until 90 days following discontinuation of the last dose of study drug, or until the initiation of the first subsequent therapy following discontinuation of treatment. All-cause mortality was reported for all randomized participants. Adverse events were reported for participants who received at least 1 dose of study drug regardless of the randomized assignment.
event Groups
  1. deaths Num Affected
    280
    deaths Num At Risk
    389
    description
    Durvalumab 1500 mg every 4 weeks (Q4W)
    id
    EG000
    other Num Affected
    299
    other Num At Risk
    388
    serious Num Affected
    115
    serious Num At Risk
    388
    title
    Durva 1500 mg
  2. deaths Num Affected
    262
    deaths Num At Risk
    393
    description
    Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W
    id
    EG001
    other Num Affected
    334
    other Num At Risk
    388
    serious Num Affected
    157
    serious Num At Risk
    388
    title
    Treme 300 mg x1 Dose + Durva 1500 mg
  3. deaths Num Affected
    123
    deaths Num At Risk
    153
    description
    Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W
    id
    EG002
    other Num Affected
    133
    other Num At Risk
    152
    serious Num Affected
    52
    serious Num At Risk
    152
    title
    Treme 75 mg x4 Doses + Durva 1500 mg
  4. deaths Num Affected
    293
    deaths Num At Risk
    389
    description
    Sorafenib 400 mg twice daily (BID)
    id
    EG003
    other Num Affected
    333
    other Num At Risk
    374
    serious Num Affected
    111
    serious Num At Risk
    374
    title
    Sora 400 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      388
      num Events
      49
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      388
      num Events
      45
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      152
      num Events
      9
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      374
      num Events
      26
    term
    Alanine aminotransferase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      388
      num Events
      11
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      388
      num Events
      38
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      152
      num Events
      6
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      374
      num Events
      17
    term
    Amylase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      388
      num Events
      63
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      388
      num Events
      53
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      152
      num Events
      17
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      374
      num Events
      33
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      388
      num Events
      30
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      388
      num Events
      23
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      152
      num Events
      5
    4. group Id
      EG003
      num Affected
      29
      num At Risk
      374
      num Events
      32
    term
    Blood bilirubin increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      388
      num Events
      12
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      388
      num Events
      18
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      152
      num Events
      7
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      374
      num Events
      24
    term
    Gamma-glutamyltransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      388
      num Events
      27
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      388
      num Events
      38
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      152
      num Events
      10
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      374
      num Events
      17
    term
    Lipase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      388
      num Events
      58
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      388
      num Events
      69
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      152
      num Events
      24
    4. group Id
      EG003
      num Affected
      67
      num At Risk
      374
      num Events
      72
    term
    Decreased appetite
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      388
      num Events
      35
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      388
      num Events
      35
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      152
      num Events
      11
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      374
      num Events
      13
    term
    Back pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      388
      num Events
      29
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      388
      num Events
      39
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      152
      num Events
      15
    4. group Id
      EG003
      num Affected
      31
      num At Risk
      374
      num Events
      32
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      388
      num Events
      4
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      388
      num Events
      11
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      152
      num Events
      12
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      374
      num Events
      14
    term
    Pain in extremity
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      388
      num Events
      21
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      388
      num Events
      44
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      152
      num Events
      10
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      374
      num Events
      16
    term
    Insomnia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      388
      num Events
      9
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      388
      num Events
      31
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      152
      num Events
      10
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      374
      num Events
      2
    term
    Hyperthyroidism
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      152
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Haemophagocytic lymphohistiocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Device related infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Enterocolitis infectious
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      388
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Gastroenteritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      374
      num Events
      1
    term
    Hepatitis c
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      374
      num Events
      1
    term
    Infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Lower respiratory tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      374
      num Events
      1
    term
    Meningitis listeria
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      388
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      388
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Necrotising fasciitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      388
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      152
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      374
      num Events
      1
    term
    Peritonitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      388
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      388
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      152
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      374
      num Events
      0
    term
    Pneumocystis jirovecii pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      388
      num Events
      3
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      388
      num Events
      7
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      152
      num Events
      6
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      374
      num Events
      8
    term
    Pneumonia
time Frame
All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO (27Aug2021, to a maximum of approximately 46 months).

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Preserved source evidence · Not medical advice