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NCT03409614 · ADVERSE EVENTS

Adverse events

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer · Source last updated 2026-05-18

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
From the time the informed consent was signed, up to approximately 83 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: Cemiplimab + Chemotherapy

Participants received cemiplimab plus platinum-based doublet chemotherapy

38 / 108102 / 10884 / 108
Part 1: Cemiplimab+AbbrevChemo+Ipilimumab

Participants received cemiplimab plus platinum-based doublet chemotherapy and ipilimumab

39 / 10997 / 10980 / 109
Part 1: Chemotherapy

Participants received platinum-based doublet chemotherapy

23 / 10394 / 10380 / 103
Part 1: Chemotherapy to Cemiplimab

Participants received optional cemiplimab treatment after experiencing PD during chemotherapy treatment period

7 / 3119 / 317 / 31
Part 2: Cemiplimab + Chemotherapy

Participants received cemiplimab plus platinum-based doublet chemotherapy

95 / 312288 / 312232 / 312
Part 2: Placebo + Chemotherapy

Placebo matching cemiplimab plus platinum-based doublet chemotherapy

38 / 153136 / 153129 / 153

Group identifiers: EG000: Part 1: Cemiplimab + Chemotherapy · EG001: Part 1: Cemiplimab+AbbrevChemo+Ipilimumab · EG002: Part 1: Chemotherapy · EG003: Part 1: Chemotherapy to Cemiplimab · EG004: Part 2: Cemiplimab + Chemotherapy · EG005: Part 2: Placebo + Chemotherapy

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 (27.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      108
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      109
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      103
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
      num Events
      2
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      312
      num Events
      10
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      153
      num Events
      5
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      312
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Cellulitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      312
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Diarrhoea infectious
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      312
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Meningitis bacterial
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      312
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Septic shock
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      312
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Acarodermatitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      312
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Appendicitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      312
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      153
      num Events
      1
    term
    Bronchitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      312
      num Events
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    COVID-19
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      312
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      153
      num Events
      1
    term
    COVID-19 pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      312
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Coronavirus infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      312
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Gastroenteritis

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      108
      num Events
      71
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      109
      num Events
      46
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      103
      num Events
      70
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      31
      num Events
      6
    5. group Id
      EG004
      num Affected
      138
      num At Risk
      312
      num Events
      239
    6. group Id
      EG005
      num Affected
      61
      num At Risk
      153
      num Events
      71
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      108
      num Events
      39
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      109
      num Events
      28
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      103
      num Events
      37
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      47
      num At Risk
      312
      num Events
      109
    6. group Id
      EG005
      num Affected
      19
      num At Risk
      153
      num Events
      44
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      108
      num Events
      34
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      109
      num Events
      12
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      103
      num Events
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      43
      num At Risk
      312
      num Events
      73
    6. group Id
      EG005
      num Affected
      19
      num At Risk
      153
      num Events
      30
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      108
      num Events
      10
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      109
      num Events
      9
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      103
      num Events
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      312
      num Events
      46
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      153
      num Events
      24
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      108
      num Events
      20
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      109
      num Events
      19
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      103
      num Events
      11
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      31
      num Events
      6
    5. group Id
      EG004
      num Affected
      55
      num At Risk
      312
      num Events
      78
    6. group Id
      EG005
      num Affected
      23
      num At Risk
      153
      num Events
      27
    term
    Alanine aminotransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      108
      num Events
      20
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      109
      num Events
      17
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      103
      num Events
      8
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      31
      num Events
      3
    5. group Id
      EG004
      num Affected
      50
      num At Risk
      312
      num Events
      82
    6. group Id
      EG005
      num Affected
      21
      num At Risk
      153
      num Events
      24
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      108
      num Events
      15
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      109
      num Events
      8
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      103
      num Events
      5
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      31
      num Events
      8
    5. group Id
      EG004
      num Affected
      38
      num At Risk
      312
      num Events
      62
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      153
      num Events
      12
    term
    Blood creatinine increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      108
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      109
      num Events
      8
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      103
      num Events
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      31
      num Events
      3
    5. group Id
      EG004
      num Affected
      42
      num At Risk
      312
      num Events
      47
    6. group Id
      EG005
      num Affected
      13
      num At Risk
      153
      num Events
      14
    term
    Weight decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      108
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      109
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
      num Events
      1
    5. group Id
      EG004
      num Affected
      18
      num At Risk
      312
      num Events
      24
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      153
      num Events
      2
    term
    Lipase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      108
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      109
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      103
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      20
      num At Risk
      312
      num Events
      33
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      153
      num Events
      11
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      108
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      109
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      22
      num At Risk
      312
      num Events
      35
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      153
      num Events
      9
    term
    Amylase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      108
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      109
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      103
      num Events
      19
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
      num Events
      1
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      312
      num Events
      38
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      153
      num Events
      14
    term
    Neutrophil count decreased
Complete source fields
event Groups
  1. deaths Num Affected
    84
    deaths Num At Risk
    108
    description
    Participants received cemiplimab plus platinum-based doublet chemotherapy
    id
    EG000
    other Num Affected
    102
    other Num At Risk
    108
    serious Num Affected
    38
    serious Num At Risk
    108
    title
    Part 1: Cemiplimab + Chemotherapy
  2. deaths Num Affected
    80
    deaths Num At Risk
    109
    description
    Participants received cemiplimab plus platinum-based doublet chemotherapy and ipilimumab
    id
    EG001
    other Num Affected
    97
    other Num At Risk
    109
    serious Num Affected
    39
    serious Num At Risk
    109
    title
    Part 1: Cemiplimab+AbbrevChemo+Ipilimumab
  3. deaths Num Affected
    80
    deaths Num At Risk
    103
    description
    Participants received platinum-based doublet chemotherapy
    id
    EG002
    other Num Affected
    94
    other Num At Risk
    103
    serious Num Affected
    23
    serious Num At Risk
    103
    title
    Part 1: Chemotherapy
  4. deaths Num Affected
    7
    deaths Num At Risk
    31
    description
    Participants received optional cemiplimab treatment after experiencing PD during chemotherapy treatment period
    id
    EG003
    other Num Affected
    19
    other Num At Risk
    31
    serious Num Affected
    7
    serious Num At Risk
    31
    title
    Part 1: Chemotherapy to Cemiplimab
  5. deaths Num Affected
    232
    deaths Num At Risk
    312
    description
    Participants received cemiplimab plus platinum-based doublet chemotherapy
    id
    EG004
    other Num Affected
    288
    other Num At Risk
    312
    serious Num Affected
    95
    serious Num At Risk
    312
    title
    Part 2: Cemiplimab + Chemotherapy
  6. deaths Num Affected
    129
    deaths Num At Risk
    153
    description
    Placebo matching cemiplimab plus platinum-based doublet chemotherapy
    id
    EG005
    other Num Affected
    136
    other Num At Risk
    153
    serious Num Affected
    38
    serious Num At Risk
    153
    title
    Part 2: Placebo + Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      108
      num Events
      71
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      109
      num Events
      46
    3. group Id
      EG002
      num Affected
      39
      num At Risk
      103
      num Events
      70
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      31
      num Events
      6
    5. group Id
      EG004
      num Affected
      138
      num At Risk
      312
      num Events
      239
    6. group Id
      EG005
      num Affected
      61
      num At Risk
      153
      num Events
      71
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      108
      num Events
      39
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      109
      num Events
      28
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      103
      num Events
      37
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      47
      num At Risk
      312
      num Events
      109
    6. group Id
      EG005
      num Affected
      19
      num At Risk
      153
      num Events
      44
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      108
      num Events
      34
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      109
      num Events
      12
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      103
      num Events
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      43
      num At Risk
      312
      num Events
      73
    6. group Id
      EG005
      num Affected
      19
      num At Risk
      153
      num Events
      30
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      108
      num Events
      10
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      109
      num Events
      9
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      103
      num Events
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      19
      num At Risk
      312
      num Events
      46
    6. group Id
      EG005
      num Affected
      10
      num At Risk
      153
      num Events
      24
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      108
      num Events
      20
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      109
      num Events
      19
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      103
      num Events
      11
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      31
      num Events
      6
    5. group Id
      EG004
      num Affected
      55
      num At Risk
      312
      num Events
      78
    6. group Id
      EG005
      num Affected
      23
      num At Risk
      153
      num Events
      27
    term
    Alanine aminotransferase increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      108
      num Events
      20
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      109
      num Events
      17
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      103
      num Events
      8
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      31
      num Events
      3
    5. group Id
      EG004
      num Affected
      50
      num At Risk
      312
      num Events
      82
    6. group Id
      EG005
      num Affected
      21
      num At Risk
      153
      num Events
      24
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      108
      num Events
      15
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      109
      num Events
      8
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      103
      num Events
      5
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      31
      num Events
      8
    5. group Id
      EG004
      num Affected
      38
      num At Risk
      312
      num Events
      62
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      153
      num Events
      12
    term
    Blood creatinine increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      108
      num Events
      9
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      109
      num Events
      8
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      103
      num Events
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      31
      num Events
      3
    5. group Id
      EG004
      num Affected
      42
      num At Risk
      312
      num Events
      47
    6. group Id
      EG005
      num Affected
      13
      num At Risk
      153
      num Events
      14
    term
    Weight decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      108
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      109
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
      num Events
      1
    5. group Id
      EG004
      num Affected
      18
      num At Risk
      312
      num Events
      24
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      153
      num Events
      2
    term
    Lipase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      108
      num Events
      12
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      109
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      103
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      20
      num At Risk
      312
      num Events
      33
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      153
      num Events
      11
    term
    Platelet count decreased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      108
      num Events
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      109
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      22
      num At Risk
      312
      num Events
      35
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      153
      num Events
      9
    term
    Amylase increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      108
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      109
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      103
      num Events
      19
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
      num Events
      1
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      312
      num Events
      38
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      153
      num Events
      14
    term
    Neutrophil count decreased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      108
      num Events
      8
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      109
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      103
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
      num Events
      2
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      312
      num Events
      10
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      153
      num Events
      5
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      108
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      109
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      312
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Cellulitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      312
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Diarrhoea infectious
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      312
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Meningitis bacterial
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      108
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      312
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Septic shock
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      312
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Acarodermatitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      103
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      312
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Appendicitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      312
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      153
      num Events
      1
    term
    Bronchitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      312
      num Events
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    COVID-19
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      312
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      153
      num Events
      1
    term
    COVID-19 pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      312
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Coronavirus infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (27.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      108
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      109
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      103
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      312
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      153
      num Events
      0
    term
    Gastroenteritis
time Frame
From the time the informed consent was signed, up to approximately 83 months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice