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NCT01704287 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002) · Source last updated 2020-05-18

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
Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)
Other-event reporting threshold
5%

Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Investigator-Choice Chemotherapy (ICC) Only

Participants received 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the final analysis. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)

33 / 7366 / 7371 / 73
ICC→Pembrolizumab 2 mg/kg (Before Switch to Pembrolizumab)

Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)

15 / 5352 / 530 / 53
ICC→Pembrolizumab 10 mg/kg (Before Switch to Pembrolizumab)

Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)

9 / 4544 / 450 / 45
Pembrolizumab 2 mg/kg

Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)

91 / 178158 / 178139 / 178
Pembrolizumab 10 mg/kg

Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)

78 / 179176 / 179129 / 179
ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab)

Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)

18 / 5348 / 5335 / 53
ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab)

Participants who were initiall randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)

18 / 4536 / 4537 / 45

Group identifiers: EG000: Investigator-Choice Chemotherapy (ICC) Only · EG001: ICC→Pembrolizumab 2 mg/kg (Before Switch to Pembrolizumab) · EG002: ICC→Pembrolizumab 10 mg/kg (Before Switch to Pembrolizumab) · EG003: Pembrolizumab 2 mg/kg · EG004: Pembrolizumab 10 mg/kg · EG005: ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab) · EG006: ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab)

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
    Endocrine disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      179
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Adrenal insufficiency
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      179
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Colitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      179
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      53
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      179
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      53
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Dysphagia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      179
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      53
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Pancreatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      178
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      179
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Rectal haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      178
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      179
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Small intestinal obstruction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      178
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      179
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      53
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Generalised oedema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      179
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Clostridium difficile colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      179
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Diverticulitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      73
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      45
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      178
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      179
      num Events
      5
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      53
      num Events
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      179
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Sepsis

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 21.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      73
      num Events
      26
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      53
      num Events
      25
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      45
      num Events
      10
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      178
      num Events
      43
    5. group Id
      EG004
      num Affected
      26
      num At Risk
      179
      num Events
      31
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      53
      num Events
      13
    7. group Id
      EG006
      num Affected
      8
      num At Risk
      45
      num Events
      21
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
      num Events
      1
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      178
      num Events
      17
    5. group Id
      EG004
      num Affected
      15
      num At Risk
      179
      num Events
      16
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      53
      num Events
      4
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      45
      num Events
      3
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      73
      num Events
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      45
      num Events
      4
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      178
      num Events
      38
    5. group Id
      EG004
      num Affected
      27
      num At Risk
      179
      num Events
      33
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      53
      num Events
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      45
      num Events
      3
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      73
      num Events
      19
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      53
      num Events
      17
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      45
      num Events
      10
    4. group Id
      EG003
      num Affected
      40
      num At Risk
      178
      num Events
      47
    5. group Id
      EG004
      num Affected
      42
      num At Risk
      179
      num Events
      57
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      53
      num Events
      14
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      45
      num Events
      6
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      73
      num Events
      20
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      53
      num Events
      17
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      45
      num Events
      17
    4. group Id
      EG003
      num Affected
      40
      num At Risk
      178
      num Events
      52
    5. group Id
      EG004
      num Affected
      41
      num At Risk
      179
      num Events
      67
    6. group Id
      EG005
      num Affected
      16
      num At Risk
      53
      num Events
      23
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      45
      num Events
      22
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      45
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      178
      num Events
      3
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      179
      num Events
      5
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      53
      num Events
      4
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      73
      num Events
      30
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      53
      num Events
      44
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      45
      num Events
      23
    4. group Id
      EG003
      num Affected
      44
      num At Risk
      178
      num Events
      74
    5. group Id
      EG004
      num Affected
      49
      num At Risk
      179
      num Events
      56
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      53
      num Events
      12
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      45
      num Events
      17
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      73
      num Events
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      53
      num Events
      14
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      45
      num Events
      14
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      178
      num Events
      26
    5. group Id
      EG004
      num Affected
      38
      num At Risk
      179
      num Events
      58
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      53
      num Events
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      73
      num Events
      11
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      45
      num Events
      2
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      178
      num Events
      25
    5. group Id
      EG004
      num Affected
      20
      num At Risk
      179
      num Events
      44
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      53
      num Events
      2
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      45
      num Events
      3
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      73
      num Events
      34
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      53
      num Events
      36
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      45
      num Events
      33
    4. group Id
      EG003
      num Affected
      74
      num At Risk
      178
      num Events
      106
    5. group Id
      EG004
      num Affected
      91
      num At Risk
      179
      num Events
      117
    6. group Id
      EG005
      num Affected
      15
      num At Risk
      53
      num Events
      17
    7. group Id
      EG006
      num Affected
      16
      num At Risk
      45
      num Events
      24
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
      num Events
      1
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      178
      num Events
      13
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      179
      num Events
      17
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      53
      num Events
      4
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      45
      num Events
      6
    term
    Influenza like illness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      73
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      53
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
      num Events
      1
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      178
      num Events
      19
    5. group Id
      EG004
      num Affected
      21
      num At Risk
      179
      num Events
      24
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      53
      num Events
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Oedema peripheral
Complete source fields
description
Safety Population: All participants who received ≥1 dose of study drug. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study drug. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
event Groups
  1. deaths Num Affected
    71
    deaths Num At Risk
    73
    description
    Participants received 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the final analysis. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    id
    EG000
    other Num Affected
    66
    other Num At Risk
    73
    serious Num Affected
    33
    serious Num At Risk
    73
    title
    Investigator-Choice Chemotherapy (ICC) Only
  2. deaths Num Affected
    0
    deaths Num At Risk
    53
    description
    Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)
    id
    EG001
    other Num Affected
    52
    other Num At Risk
    53
    serious Num Affected
    15
    serious Num At Risk
    53
    title
    ICC→Pembrolizumab 2 mg/kg (Before Switch to Pembrolizumab)
  3. deaths Num Affected
    0
    deaths Num At Risk
    45
    description
    Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)
    id
    EG002
    other Num Affected
    44
    other Num At Risk
    45
    serious Num Affected
    9
    serious Num At Risk
    45
    title
    ICC→Pembrolizumab 10 mg/kg (Before Switch to Pembrolizumab)
  4. deaths Num Affected
    139
    deaths Num At Risk
    178
    description
    Participants were initially randomized to receive pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    id
    EG003
    other Num Affected
    158
    other Num At Risk
    178
    serious Num Affected
    91
    serious Num At Risk
    178
    title
    Pembrolizumab 2 mg/kg
  5. deaths Num Affected
    129
    deaths Num At Risk
    179
    description
    Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to \~66 months)
    id
    EG004
    other Num Affected
    176
    other Num At Risk
    179
    serious Num Affected
    78
    serious Num At Risk
    179
    title
    Pembrolizumab 10 mg/kg
  6. deaths Num Affected
    35
    deaths Num At Risk
    53
    description
    Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)
    id
    EG005
    other Num Affected
    48
    other Num At Risk
    53
    serious Num Affected
    18
    serious Num At Risk
    53
    title
    ICC→Pembrolizumab 2 mg/kg (After Switch to Pembrolizumab)
  7. deaths Num Affected
    37
    deaths Num At Risk
    45
    description
    Participants who were initiall randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to \~66 months)
    id
    EG006
    other Num Affected
    36
    other Num At Risk
    45
    serious Num Affected
    18
    serious Num At Risk
    45
    title
    ICC→Pembrolizumab 10 mg/kg (After Switch to Pembrolizumab)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      73
      num Events
      26
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      53
      num Events
      25
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      45
      num Events
      10
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      178
      num Events
      43
    5. group Id
      EG004
      num Affected
      26
      num At Risk
      179
      num Events
      31
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      53
      num Events
      13
    7. group Id
      EG006
      num Affected
      8
      num At Risk
      45
      num Events
      21
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
      num Events
      1
    4. group Id
      EG003
      num Affected
      16
      num At Risk
      178
      num Events
      17
    5. group Id
      EG004
      num Affected
      15
      num At Risk
      179
      num Events
      16
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      53
      num Events
      4
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      45
      num Events
      3
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      73
      num Events
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
      num Events
      2
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      45
      num Events
      4
    4. group Id
      EG003
      num Affected
      28
      num At Risk
      178
      num Events
      38
    5. group Id
      EG004
      num Affected
      27
      num At Risk
      179
      num Events
      33
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      53
      num Events
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      45
      num Events
      3
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      73
      num Events
      19
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      53
      num Events
      17
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      45
      num Events
      10
    4. group Id
      EG003
      num Affected
      40
      num At Risk
      178
      num Events
      47
    5. group Id
      EG004
      num Affected
      42
      num At Risk
      179
      num Events
      57
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      53
      num Events
      14
    7. group Id
      EG006
      num Affected
      6
      num At Risk
      45
      num Events
      6
    term
    Constipation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      73
      num Events
      20
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      53
      num Events
      17
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      45
      num Events
      17
    4. group Id
      EG003
      num Affected
      40
      num At Risk
      178
      num Events
      52
    5. group Id
      EG004
      num Affected
      41
      num At Risk
      179
      num Events
      67
    6. group Id
      EG005
      num Affected
      16
      num At Risk
      53
      num Events
      23
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      45
      num Events
      22
    term
    Diarrhoea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      53
      num Events
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      45
      num Events
      3
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      178
      num Events
      3
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      179
      num Events
      5
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      53
      num Events
      4
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Dyspepsia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      73
      num Events
      30
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      53
      num Events
      44
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      45
      num Events
      23
    4. group Id
      EG003
      num Affected
      44
      num At Risk
      178
      num Events
      74
    5. group Id
      EG004
      num Affected
      49
      num At Risk
      179
      num Events
      56
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      53
      num Events
      12
    7. group Id
      EG006
      num Affected
      10
      num At Risk
      45
      num Events
      17
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      73
      num Events
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      53
      num Events
      14
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      45
      num Events
      14
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      178
      num Events
      26
    5. group Id
      EG004
      num Affected
      38
      num At Risk
      179
      num Events
      58
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      53
      num Events
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      73
      num Events
      11
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      53
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      45
      num Events
      2
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      178
      num Events
      25
    5. group Id
      EG004
      num Affected
      20
      num At Risk
      179
      num Events
      44
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      53
      num Events
      2
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      45
      num Events
      3
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      73
      num Events
      34
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      53
      num Events
      36
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      45
      num Events
      33
    4. group Id
      EG003
      num Affected
      74
      num At Risk
      178
      num Events
      106
    5. group Id
      EG004
      num Affected
      91
      num At Risk
      179
      num Events
      117
    6. group Id
      EG005
      num Affected
      15
      num At Risk
      53
      num Events
      17
    7. group Id
      EG006
      num Affected
      16
      num At Risk
      45
      num Events
      24
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
      num Events
      1
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      178
      num Events
      13
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      179
      num Events
      17
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      53
      num Events
      4
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      45
      num Events
      6
    term
    Influenza like illness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      73
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      53
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
      num Events
      1
    4. group Id
      EG003
      num Affected
      17
      num At Risk
      178
      num Events
      19
    5. group Id
      EG004
      num Affected
      21
      num At Risk
      179
      num Events
      24
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      53
      num Events
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      45
      num Events
      2
    term
    Oedema peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      179
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Adrenal insufficiency
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      179
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Colitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      179
      num Events
      4
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      53
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      179
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      53
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Dysphagia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      179
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      53
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Pancreatitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      178
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      179
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Rectal haemorrhage
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      178
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      179
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Small intestinal obstruction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      73
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      178
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      179
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      53
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      45
      num Events
      0
    term
    Generalised oedema
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      179
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Clostridium difficile colitis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      73
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      179
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Diverticulitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      73
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      53
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      45
      num Events
      2
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      178
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      179
      num Events
      5
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      53
      num Events
      3
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 21.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      73
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      53
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      178
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      179
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      53
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      45
      num Events
      1
    term
    Sepsis
time Frame
Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)

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Preserved source evidence · Not medical advice