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NCT01905657 · ADVERSE EVENTS

Adverse events

Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010) · Source last updated 2021-10-06

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
Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Other-event reporting threshold
5%

Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pembrolizumab 2 mg/kg First Course

Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.

124 / 339312 / 339294 / 345
Pembrolizumab 10 mg/kg First Course

Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.

133 / 343301 / 343289 / 346
Docetaxel 75 mg/m^2

Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years.

107 / 309279 / 309303 / 343
Pembrolizumab 2 mg/kg First Course to Pembrolizumab 200 mg Second Course

Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.

5 / 149 / 144 / 14
Pembrolizumab 10 mg/kg First Course to Pembrolizumab 200 mg Second Course

Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.

2 / 75 / 72 / 7
Docetaxel 75 mg/m^2 Switched Over to Pembrolizumab 200 mg

Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.

1 / 87 / 86 / 8

Group identifiers: EG000: Pembrolizumab 2 mg/kg First Course · EG001: Pembrolizumab 10 mg/kg First Course · EG002: Docetaxel 75 mg/m^2 · EG003: Pembrolizumab 2 mg/kg First Course to Pembrolizumab 200 mg Second Course · EG004: Pembrolizumab 10 mg/kg First Course to Pembrolizumab 200 mg Second Course · EG005: Docetaxel 75 mg/m^2 Switched Over to Pembrolizumab 200 mg

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      339
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      343
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      309
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      339
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      309
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      339
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      343
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      309
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Eosinophilia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      339
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      343
      num Events
      1
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      309
      num Events
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      339
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      309
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      339
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      309
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Lymph node pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      339
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      343
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      309
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Microcytic anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      339
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      309
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      339
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      309
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Normocytic anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      339
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      309
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Acute coronary syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      339
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      309
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Acute myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      339
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      343
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      309
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Arrhythmia

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      339
      num Events
      50
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      343
      num Events
      43
    3. group Id
      EG002
      num Affected
      61
      num At Risk
      309
      num Events
      71
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      339
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      343
      num Events
      3
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      309
      num Events
      103
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      339
      num Events
      13
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      343
      num Events
      19
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      309
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      339
      num Events
      30
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      343
      num Events
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      309
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      339
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      343
      num Events
      3
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      309
      num Events
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Lacrimation increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      339
      num Events
      24
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      343
      num Events
      23
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      309
      num Events
      17
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      339
      num Events
      65
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      343
      num Events
      64
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      309
      num Events
      47
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      339
      num Events
      91
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      343
      num Events
      62
    3. group Id
      EG002
      num Affected
      81
      num At Risk
      309
      num Events
      111
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
      num Events
      5
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      339
      num Events
      105
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      343
      num Events
      92
    3. group Id
      EG002
      num Affected
      65
      num At Risk
      309
      num Events
      80
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      339
      num Events
      22
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      343
      num Events
      15
    3. group Id
      EG002
      num Affected
      49
      num At Risk
      309
      num Events
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      339
      num Events
      60
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      343
      num Events
      59
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      309
      num Events
      37
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      339
      num Events
      60
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      343
      num Events
      59
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      309
      num Events
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Asthenia
Complete source fields
description
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
event Groups
  1. deaths Num Affected
    294
    deaths Num At Risk
    345
    description
    Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
    id
    EG000
    other Num Affected
    312
    other Num At Risk
    339
    serious Num Affected
    124
    serious Num At Risk
    339
    title
    Pembrolizumab 2 mg/kg First Course
  2. deaths Num Affected
    289
    deaths Num At Risk
    346
    description
    Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
    id
    EG001
    other Num Affected
    301
    other Num At Risk
    343
    serious Num Affected
    133
    serious Num At Risk
    343
    title
    Pembrolizumab 10 mg/kg First Course
  3. deaths Num Affected
    303
    deaths Num At Risk
    343
    description
    Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years.
    id
    EG002
    other Num Affected
    279
    other Num At Risk
    309
    serious Num Affected
    107
    serious Num At Risk
    309
    title
    Docetaxel 75 mg/m^2
  4. deaths Num Affected
    4
    deaths Num At Risk
    14
    description
    Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    14
    serious Num Affected
    5
    serious Num At Risk
    14
    title
    Pembrolizumab 2 mg/kg First Course to Pembrolizumab 200 mg Second Course
  5. deaths Num Affected
    2
    deaths Num At Risk
    7
    description
    Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
    id
    EG004
    other Num Affected
    5
    other Num At Risk
    7
    serious Num Affected
    2
    serious Num At Risk
    7
    title
    Pembrolizumab 10 mg/kg First Course to Pembrolizumab 200 mg Second Course
  6. deaths Num Affected
    6
    deaths Num At Risk
    8
    description
    Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
    id
    EG005
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    1
    serious Num At Risk
    8
    title
    Docetaxel 75 mg/m^2 Switched Over to Pembrolizumab 200 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      339
      num Events
      50
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      343
      num Events
      43
    3. group Id
      EG002
      num Affected
      61
      num At Risk
      309
      num Events
      71
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      339
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      343
      num Events
      3
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      309
      num Events
      103
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      339
      num Events
      13
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      343
      num Events
      19
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      309
      num Events
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Hyperthyroidism
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      339
      num Events
      30
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      343
      num Events
      34
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      309
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Hypothyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      339
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      343
      num Events
      3
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      309
      num Events
      18
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Lacrimation increased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      339
      num Events
      24
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      343
      num Events
      23
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      309
      num Events
      17
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      14
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      59
      num At Risk
      339
      num Events
      65
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      343
      num Events
      64
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      309
      num Events
      47
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      339
      num Events
      91
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      343
      num Events
      62
    3. group Id
      EG002
      num Affected
      81
      num At Risk
      309
      num Events
      111
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
      num Events
      2
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      8
      num Events
      5
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      87
      num At Risk
      339
      num Events
      105
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      343
      num Events
      92
    3. group Id
      EG002
      num Affected
      65
      num At Risk
      309
      num Events
      80
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      8
      num Events
      1
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      339
      num Events
      22
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      343
      num Events
      15
    3. group Id
      EG002
      num Affected
      49
      num At Risk
      309
      num Events
      72
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      14
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      339
      num Events
      60
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      343
      num Events
      59
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      309
      num Events
      37
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
      num Events
      1
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      339
      num Events
      60
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      343
      num Events
      59
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      309
      num Events
      72
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      2
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      339
      num Events
      3
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      343
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      309
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      339
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      309
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      339
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      343
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      309
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Eosinophilia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      339
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      343
      num Events
      1
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      309
      num Events
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      339
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      309
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      339
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      309
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Lymph node pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      339
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      343
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      309
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Microcytic anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      339
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      309
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Neutropenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      339
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      309
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Normocytic anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      339
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      309
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Acute coronary syndrome
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      339
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      343
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      309
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Acute myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      339
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      343
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      309
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      14
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      8
      num Events
      0
    term
    Arrhythmia
time Frame
Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses

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Preserved source evidence · Not medical advice