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NCT02737501 · ADVERSE EVENTS

Adverse events

ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants · Source last updated 2021-08-20

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-Cause Mortality - Up to 56 months; Serious and other adverse events - From first dose up to 30 days after last dose of study drug (Up to approximately 37 months)
Other-event reporting threshold
5%

All Cause-mortality: ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Serious and other (Non-serious): Treated Population included all participants who received ≥1 dose of study drug and served as basis of safety analysis. Crossover Population included participants from 'Crizotinib 250 mg BID' who crossed over to brigatinib following BIRC-assessed PD.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Randomized Phase: Brigatinib 90 mg QD/180 QD

Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).

56 / 136132 / 13641 / 137
Randomized Phase: Crizotinib 250 mg BID

Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).

53 / 137135 / 13729 / 138
Crossover Phase: Brigatinib 90 mg QD/180 mg QD

Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).

24 / 6563 / 6522 / 65

Group identifiers: EG000: Randomized Phase: Brigatinib 90 mg QD/180 QD · EG001: Randomized Phase: Crizotinib 250 mg BID · EG002: Crossover Phase: Brigatinib 90 mg QD/180 mg QD

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      65
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    term
    Lower Respiratory Tract Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Urinary Tract Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Appendicitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Upper Respiratory Tract Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    term
    Gastroenteritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Viral Infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Respiratory Tract Infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Cellulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Cytomegalovirus Oesophagitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Herpes Zoster
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Listeriosis

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      65
    term
    Upper Respiratory Tract Infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      65
    term
    Nasopharyngitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      65
    term
    Urinary Tract Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      65
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Respiratory Tract Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      65
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      65
    term
    Decreased Appetite
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Hyperglycaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Hypophosphataemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Hypokalaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Hypercholesterolaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Hypocalcaemia
Complete source fields
description
All Cause-mortality: ITT Population included all participants randomized to each regimen regardless of whether they tested ALK+, or whether they received study drug or adhered to the assigned dose. Serious and other (Non-serious): Treated Population included all participants who received ≥1 dose of study drug and served as basis of safety analysis. Crossover Population included participants from 'Crizotinib 250 mg BID' who crossed over to brigatinib following BIRC-assessed PD.
event Groups
  1. deaths Num Affected
    41
    deaths Num At Risk
    137
    description
    Brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, orally, QD, in each 28-day cycle until PD, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 34.86 months).
    id
    EG000
    other Num Affected
    132
    other Num At Risk
    136
    serious Num Affected
    56
    serious Num At Risk
    136
    title
    Randomized Phase: Brigatinib 90 mg QD/180 QD
  2. deaths Num Affected
    29
    deaths Num At Risk
    138
    description
    Crizotinib 250 mg, tablets, BID in each 28-day cycle until disease progression, intolerable toxicity, consent withdrawal, or death (The median duration of exposure was 9.26 months).
    id
    EG001
    other Num Affected
    135
    other Num At Risk
    137
    serious Num Affected
    53
    serious Num At Risk
    137
    title
    Randomized Phase: Crizotinib 250 mg BID
  3. deaths Num Affected
    22
    deaths Num At Risk
    65
    description
    Participants who experienced PD as assessed by the BIRC or received radiotherapy to the brain while on 'Crizotinib 250 mg BID' therapy in Randomized Phase were crossed over. Following 10-day washout period, crossover participants received brigatinib 90 mg, tablets, orally, QD for first 7 days followed by 180 mg, tablets, orally, QD in each 28-day cycle up to end of the study (The median duration of exposure was 17.25 months).
    id
    EG002
    other Num Affected
    63
    other Num At Risk
    65
    serious Num Affected
    24
    serious Num At Risk
    65
    title
    Crossover Phase: Brigatinib 90 mg QD/180 mg QD
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      65
    term
    Upper Respiratory Tract Infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      65
    term
    Nasopharyngitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      65
    term
    Urinary Tract Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      65
    term
    Pneumonia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Respiratory Tract Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      65
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      65
    term
    Decreased Appetite
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Hyperglycaemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Hypophosphataemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Hypokalaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Hypercholesterolaemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Hypocalcaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      65
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    term
    Lower Respiratory Tract Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Urinary Tract Infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Appendicitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Upper Respiratory Tract Infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      65
    term
    Gastroenteritis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Viral Infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Respiratory Tract Infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Cellulitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Cytomegalovirus Oesophagitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Herpes Zoster
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      136
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      137
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      65
    term
    Listeriosis
time Frame
All-Cause Mortality - Up to 56 months; Serious and other adverse events - From first dose up to 30 days after last dose of study drug (Up to approximately 37 months)

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Preserved source evidence · Not medical advice