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NCT02760498 · ADVERSE EVENTS

Adverse events

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma · Source last updated 2025-05-28

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 signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)
Other-event reporting threshold
5%

The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W

Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).

24 / 5956 / 5927 / 59
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W

Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).

28 / 7875 / 7819 / 78
Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W

Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).

23 / 5649 / 5626 / 56
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W

Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).

35 / 6359 / 6323 / 63
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W

Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).

2 / 99 / 92 / 9
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W

Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).

85 / 165147 / 16559 / 165
Group 6a (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 350 mg SC Q3W

Participants in group 6 who received cemiplimab 350 mg IV Q3W and opted to switch to cemiplimab 350 mg SC Q3W for up to a total (IV + SC) of 108 weeks.

4 / 129 / 122 / 12
Group 6b (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 1050 mg SC Q6W

Participants in group 6 who received cemiplimab 350 mg IV Q3W and opted to switch to cemiplimab 1050 mg SC Q6W for up to a total (IV + SC) of 108 weeks.

1 / 75 / 70 / 7

Group identifiers: EG000: Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W · EG001: Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W · EG002: Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W · EG003: Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W · EG004: Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W · EG005: Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W · EG006: Group 6a (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 350 mg SC Q3W · EG007: Group 6b (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 1050 mg SC Q6W

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 (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      59
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      78
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      63
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      165
      num Events
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      59
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      78
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      56
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      63
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      165
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Cellulitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      78
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      56
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      63
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      165
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Encephalitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Erysipelas
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Extradural abscess
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Gastroenteritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Influenza
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Pneumonia aspiration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Pneumonia influenzal
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Psoas abscess
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      56
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Skin infection

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      59
      num Events
      29
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      78
      num Events
      42
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      56
      num Events
      18
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      63
      num Events
      23
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      9
      num Events
      3
    6. group Id
      EG005
      num Affected
      39
      num At Risk
      165
      num Events
      58
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      2
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      59
      num Events
      17
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      78
      num Events
      25
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      56
      num Events
      12
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      63
      num Events
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      9
      num Events
      2
    6. group Id
      EG005
      num Affected
      33
      num At Risk
      165
      num Events
      37
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      59
      num Events
      3
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      78
      num Events
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      59
      num Events
      8
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      78
      num Events
      13
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      56
      num Events
      8
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      63
      num Events
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      17
      num At Risk
      165
      num Events
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      59
      num Events
      12
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      78
      num Events
      11
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      56
      num Events
      11
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      63
      num Events
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      22
      num At Risk
      165
      num Events
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      78
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      56
      num Events
      4
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      63
      num Events
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Dysphagia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      9
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      59
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      56
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      59
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Gastrooesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Poor dental condition
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      59
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Toothache
Complete source fields
description
The Safety Analysis Set (SAF) included all enrolled participants who received any study drug.
event Groups
  1. deaths Num Affected
    27
    deaths Num At Risk
    59
    description
    Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
    id
    EG000
    other Num Affected
    56
    other Num At Risk
    59
    serious Num Affected
    24
    serious Num At Risk
    59
    title
    Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W
  2. deaths Num Affected
    19
    deaths Num At Risk
    78
    description
    Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
    id
    EG001
    other Num Affected
    75
    other Num At Risk
    78
    serious Num Affected
    28
    serious Num At Risk
    78
    title
    Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W
  3. deaths Num Affected
    26
    deaths Num At Risk
    56
    description
    Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
    id
    EG002
    other Num Affected
    49
    other Num At Risk
    56
    serious Num Affected
    23
    serious Num At Risk
    56
    title
    Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W
  4. deaths Num Affected
    23
    deaths Num At Risk
    63
    description
    Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
    id
    EG003
    other Num Affected
    59
    other Num At Risk
    63
    serious Num Affected
    35
    serious Num At Risk
    63
    title
    Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W
  5. deaths Num Affected
    2
    deaths Num At Risk
    9
    description
    Participants received a single 438 mg subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
    id
    EG004
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    2
    serious Num At Risk
    9
    title
    Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W
  6. deaths Num Affected
    59
    deaths Num At Risk
    165
    description
    Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
    id
    EG005
    other Num Affected
    147
    other Num At Risk
    165
    serious Num Affected
    85
    serious Num At Risk
    165
    title
    Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W
  7. deaths Num Affected
    2
    deaths Num At Risk
    12
    description
    Participants in group 6 who received cemiplimab 350 mg IV Q3W and opted to switch to cemiplimab 350 mg SC Q3W for up to a total (IV + SC) of 108 weeks.
    id
    EG006
    other Num Affected
    9
    other Num At Risk
    12
    serious Num Affected
    4
    serious Num At Risk
    12
    title
    Group 6a (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 350 mg SC Q3W
  8. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    Participants in group 6 who received cemiplimab 350 mg IV Q3W and opted to switch to cemiplimab 1050 mg SC Q6W for up to a total (IV + SC) of 108 weeks.
    id
    EG007
    other Num Affected
    5
    other Num At Risk
    7
    serious Num Affected
    1
    serious Num At Risk
    7
    title
    Group 6b (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 1050 mg SC Q6W
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      59
      num Events
      29
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      78
      num Events
      42
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      56
      num Events
      18
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      63
      num Events
      23
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      9
      num Events
      3
    6. group Id
      EG005
      num Affected
      39
      num At Risk
      165
      num Events
      58
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      2
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      59
      num Events
      17
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      78
      num Events
      25
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      56
      num Events
      12
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      63
      num Events
      6
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      9
      num Events
      2
    6. group Id
      EG005
      num Affected
      33
      num At Risk
      165
      num Events
      37
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      59
      num Events
      3
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      78
      num Events
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
      num Events
      1
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      59
      num Events
      8
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      78
      num Events
      13
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      56
      num Events
      8
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      63
      num Events
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      17
      num At Risk
      165
      num Events
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Vomiting
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      59
      num Events
      12
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      78
      num Events
      11
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      56
      num Events
      11
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      63
      num Events
      16
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      22
      num At Risk
      165
      num Events
      25
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      78
      num Events
      4
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      56
      num Events
      4
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      63
      num Events
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Dysphagia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      9
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Colitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      59
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      56
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Dry mouth
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      59
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Gastrooesophageal reflux disease
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Poor dental condition
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      9
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      59
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      78
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Toothache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      59
      num Events
      2
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      78
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      63
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      165
      num Events
      9
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      59
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      78
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      56
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      63
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      165
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Cellulitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      78
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      56
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      63
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      165
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Encephalitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Erysipelas
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Extradural abscess
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Gastroenteritis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Influenza
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      12
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Pneumonia aspiration
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Pneumonia influenzal
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      59
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      56
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Psoas abscess
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (24.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      59
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      78
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      56
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      63
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      9
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      165
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      12
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
      num Events
      0
    term
    Skin infection
time Frame
From signing of informed consent through end of study up to approximately 65 months (treatment period + follow-up including survival follow-up)

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

Preserved source evidence · Not medical advice