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NCT04105010 · ADVERSE EVENTS

Adverse events

Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8) · Source last updated 2025-04-04

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
The first dose until 28 days after last dose, up to approximately 3 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
AZD4205 Group A

Group A: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

12 / 2826 / 283 / 28
AZD4205 Group B

Group B: Open label AZD4205 at 250 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

9 / 1616 / 162 / 16
AZD4205 Group C

Group C: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

1 / 76 / 71 / 7
AZD4205 Group D

Group D: Open label AZD4205 at 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

44 / 120114 / 12054 / 120

Group identifiers: EG000: AZD4205 Group A · EG001: AZD4205 Group B · EG002: AZD4205 Group C · EG003: AZD4205 Group D

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
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      120
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      120
    term
    herpes zoster
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      120
    term
    COVID-19 pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      120
    term
    Febrile infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      120
    term
    Upper respiratory tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Anal abscess
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Bacteraemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Bacterial sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Cytomegalovirus chorioretinitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Cytomegalovirus infection reactivation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Meningitis viral

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
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      71
      num At Risk
      120
    term
    Platelet count decreased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      62
      num At Risk
      120
    term
    Neutrophil count decreased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      62
      num At Risk
      120
    term
    White blood cell count decreased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      36
      num At Risk
      120
    term
    Lymphocyte count decreased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      33
      num At Risk
      120
    term
    Aspartate aminotransferase increased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      120
    term
    Alanine aminotransferase increased
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      120
    term
    Blood lactate dehydrogenase increased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      120
    term
    Blood creatinine increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      120
    term
    Blood fibrinogen decreased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      120
    term
    Blood creatine phosphokinase increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      120
    term
    C-reactive protein increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      120
    term
    Gamma-glutamyltransferase increased
Complete source fields
event Groups
  1. deaths Num Affected
    3
    deaths Num At Risk
    28
    description
    Group A: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
    id
    EG000
    other Num Affected
    26
    other Num At Risk
    28
    serious Num Affected
    12
    serious Num At Risk
    28
    title
    AZD4205 Group A
  2. deaths Num Affected
    2
    deaths Num At Risk
    16
    description
    Group B: Open label AZD4205 at 250 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
    id
    EG001
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    9
    serious Num At Risk
    16
    title
    AZD4205 Group B
  3. deaths Num Affected
    1
    deaths Num At Risk
    7
    description
    Group C: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    7
    serious Num Affected
    1
    serious Num At Risk
    7
    title
    AZD4205 Group C
  4. deaths Num Affected
    54
    deaths Num At Risk
    120
    description
    Group D: Open label AZD4205 at 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
    id
    EG003
    other Num Affected
    114
    other Num At Risk
    120
    serious Num Affected
    44
    serious Num At Risk
    120
    title
    AZD4205 Group D
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      71
      num At Risk
      120
    term
    Platelet count decreased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      62
      num At Risk
      120
    term
    Neutrophil count decreased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      62
      num At Risk
      120
    term
    White blood cell count decreased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      36
      num At Risk
      120
    term
    Lymphocyte count decreased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      33
      num At Risk
      120
    term
    Aspartate aminotransferase increased
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      120
    term
    Alanine aminotransferase increased
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      120
    term
    Blood lactate dehydrogenase increased
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      120
    term
    Blood creatinine increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      120
    term
    Blood fibrinogen decreased
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      120
    term
    Blood creatine phosphokinase increased
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      12
      num At Risk
      120
    term
    C-reactive protein increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      120
    term
    Gamma-glutamyltransferase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      120
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      120
    term
    herpes zoster
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      120
    term
    COVID-19 pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      120
    term
    Febrile infection
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      120
    term
    Upper respiratory tract infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Anal abscess
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Bacteraemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Bacterial sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Cytomegalovirus chorioretinitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Cytomegalovirus infection reactivation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      28
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      16
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      7
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      120
    term
    Meningitis viral
time Frame
The first dose until 28 days after last dose, up to approximately 3 years

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