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NCT03329690 · ADVERSE EVENTS

Adverse events

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01] · Source last updated 2022-03-18

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
Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.
Other-event reporting threshold
5%

A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
DS-8201a

Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.

58 / 125125 / 12598 / 125
Physician's Choice Irinotecan

Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.

15 / 5554 / 5546 / 55
Physician's Choice Paclitaxel

Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.

1 / 77 / 74 / 7
Physician's Choice Overall

Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.

16 / 6261 / 6250 / 62
Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a

Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.

6 / 2020 / 2016 / 20
Exploratory: Naïve HER2 IHC 1+, DS-8201a

Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.

11 / 2424 / 2421 / 24

Group identifiers: EG000: DS-8201a · EG001: Physician's Choice Irinotecan · EG002: Physician's Choice Paclitaxel · EG003: Physician's Choice Overall · EG004: Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a · EG005: Exploratory: Naïve HER2 IHC 1+, DS-8201a

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
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
    term
    Sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
    term
    Lung infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Pneumonia bacterial
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Bacteraemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Biliary sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Biliary tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Device-related infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Infectious pleural effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Cholangitis infective
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Tumour haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Neoplasm progression

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
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      24
    term
    Nasopharyngitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
    term
    Upper respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
    term
    Lung infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
    term
    Influenza
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Pneumonia bacterial
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Conjunctivitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Folliculitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Cellulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Pneumonia staphylococcal
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      24
    term
    Cancer pain
Complete source fields
description
A TEAE is defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug. Serious adverse events (SAEs) with an onset or worsening 48 days or more after the last dose of study drug, if considered related to the study treatment, are also TEAEs.
event Groups
  1. deaths Num Affected
    98
    deaths Num At Risk
    125
    description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
    id
    EG000
    other Num Affected
    125
    other Num At Risk
    125
    serious Num Affected
    58
    serious Num At Risk
    125
    title
    DS-8201a
  2. deaths Num Affected
    46
    deaths Num At Risk
    55
    description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
    id
    EG001
    other Num Affected
    54
    other Num At Risk
    55
    serious Num Affected
    15
    serious Num At Risk
    55
    title
    Physician's Choice Irinotecan
  3. deaths Num Affected
    4
    deaths Num At Risk
    7
    description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
    id
    EG002
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    1
    serious Num At Risk
    7
    title
    Physician's Choice Paclitaxel
  4. deaths Num Affected
    50
    deaths Num At Risk
    62
    description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive either irinotecan or paclitaxel monotherapy as prescribed by the physician before enrollment.
    id
    EG003
    other Num Affected
    61
    other Num At Risk
    62
    serious Num Affected
    16
    serious Num At Risk
    62
    title
    Physician's Choice Overall
  5. deaths Num Affected
    16
    deaths Num At Risk
    20
    description
    Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
    id
    EG004
    other Num Affected
    20
    other Num At Risk
    20
    serious Num Affected
    6
    serious Num At Risk
    20
    title
    Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
  6. deaths Num Affected
    21
    deaths Num At Risk
    24
    description
    Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
    id
    EG005
    other Num Affected
    24
    other Num At Risk
    24
    serious Num Affected
    11
    serious Num At Risk
    24
    title
    Exploratory: Naïve HER2 IHC 1+, DS-8201a
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      24
    term
    Nasopharyngitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
    term
    Pneumonia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
    term
    Upper respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
    term
    Lung infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
    term
    Influenza
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Pneumonia bacterial
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Conjunctivitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Folliculitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Cellulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Pneumonia staphylococcal
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      24
    term
    Cancer pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
    term
    Sepsis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      24
    term
    Lung infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Pneumonia bacterial
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Bacteraemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Biliary sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Biliary tract infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Device-related infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Infectious pleural effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Cholangitis infective
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Tumour haemorrhage
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 20.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      125
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      55
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      20
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      24
    term
    Neoplasm progression
time Frame
Treatment-emergent adverse event (TEAE) data were collected from baseline up to 47 days after last dose, up to 36 months postdose.

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