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NCT02296125 · ADVERSE EVENTS

Adverse events

AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer · Source last updated 2026-04-21

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 adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued
Other-event reporting threshold
5%

An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Osimertinib 80 mg (Global Cohort)

Randomized participants received Osimertinib 80 mg orally once daily (QD)

74 / 279273 / 279155 / 279
SoC EGFR-TKI (Global Cohort)

Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.

76 / 277271 / 277166 / 277
Osimertinib 80 mg (China Cohort)

Randomized participants received Osimertinib 80 mg orally once daily (QD)

25 / 7170 / 7145 / 71
SoC EGFR-TKI (China Cohort)

Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.

12 / 6564 / 6544 / 65

Group identifiers: EG000: Osimertinib 80 mg (Global Cohort) · EG001: SoC EGFR-TKI (Global Cohort) · EG002: Osimertinib 80 mg (China Cohort) · EG003: SoC EGFR-TKI (China Cohort)

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Anal abscess
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Bacteraemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Clostridial infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Clostridium difficile infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Cystitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Device related infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Diarrhoea infectious
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Diverticulitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Empyema
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Endocarditis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Enteritis infectious
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Escherichia urinary tract infection

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      167
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      162
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      65
    term
    Diarrhoea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      136
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      65
    term
    Dermatitis acneiform
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      65
    term
    Dry skin
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      65
    term
    Paronychia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Stomatitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      65
    term
    Decreased appetite
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      65
    term
    Aspartate aminotransferase increased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      65
    term
    Pruritus
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      65
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      65
    term
    Cough
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      65
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      65
    term
    Fatigue
Complete source fields
description
An adverse event was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. In clinical studies, an AE included an undesirable medical condition occurring at any time, including run-in or washout periods, even if no study treatment had been administered. The term AE was used to include both serious and non-serious AEs.
event Groups
  1. deaths Num Affected
    155
    deaths Num At Risk
    279
    description
    Randomized participants received Osimertinib 80 mg orally once daily (QD)
    id
    EG000
    other Num Affected
    273
    other Num At Risk
    279
    serious Num Affected
    74
    serious Num At Risk
    279
    title
    Osimertinib 80 mg (Global Cohort)
  2. deaths Num Affected
    166
    deaths Num At Risk
    277
    description
    Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
    id
    EG001
    other Num Affected
    271
    other Num At Risk
    277
    serious Num Affected
    76
    serious Num At Risk
    277
    title
    SoC EGFR-TKI (Global Cohort)
  3. deaths Num Affected
    45
    deaths Num At Risk
    71
    description
    Randomized participants received Osimertinib 80 mg orally once daily (QD)
    id
    EG002
    other Num Affected
    70
    other Num At Risk
    71
    serious Num Affected
    25
    serious Num At Risk
    71
    title
    Osimertinib 80 mg (China Cohort)
  4. deaths Num Affected
    44
    deaths Num At Risk
    65
    description
    Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.
    id
    EG003
    other Num Affected
    64
    other Num At Risk
    65
    serious Num Affected
    12
    serious Num At Risk
    65
    title
    SoC EGFR-TKI (China Cohort)
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      167
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      162
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      65
    term
    Diarrhoea
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      136
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      65
    term
    Dermatitis acneiform
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      65
    term
    Dry skin
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      65
    term
    Paronychia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Stomatitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      66
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      65
    term
    Decreased appetite
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      65
    term
    Aspartate aminotransferase increased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      65
    term
    Pruritus
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      65
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      65
    term
    Cough
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      65
    term
    Constipation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      65
    term
    Fatigue
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Anal abscess
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Bacteraemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Clostridial infection
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Clostridium difficile infection
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Cystitis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Device related infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Diarrhoea infectious
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Diverticulitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Empyema
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Endocarditis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Enteritis infectious
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      279
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      277
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      71
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      65
    term
    Escherichia urinary tract infection
time Frame
All adverse events (AEs) were collected from the time of signature of informed consent throughout the Treatment Period and including the safety follow-up period.The safety follow-up period was defined as 28 days after study drug was discontinued

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Preserved source evidence · Not medical advice