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NCT02819518 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355) · Source last updated 2024-11-27

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 81 months
Other-event reporting threshold
5%

All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: Pembrolizumab + Nab-Paclitaxel

Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.

3 / 1313 / 139 / 11
Part 1: Pembrolizumab + Paclitaxel

Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.

4 / 1010 / 1012 / 14
Part 1: Pembrolizumab + Gemcitabine/Carboplatin

Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.

9 / 1111 / 119 / 10
Part 2: Pembrolizumab + Chemotherapy (First Course)

Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to \~1 year).

169 / 562551 / 562484 / 566
Part 2: Pembrolizumab + Chemotherapy (Second Course)

Eligible participants received up to 17 additional administrations (up to approximately 1year) of pembrolizumab 200 mg IV on day 1 of each 21-day cycle.

3 / 1211 / 125 / 12
Part 2: Placebo + Chemotherapy

Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle

68 / 281273 / 281249 / 281

Group identifiers: EG000: Part 1: Pembrolizumab + Nab-Paclitaxel · EG001: Part 1: Pembrolizumab + Paclitaxel · EG002: Part 1: Pembrolizumab + Gemcitabine/Carboplatin · EG003: Part 2: Pembrolizumab + Chemotherapy (First Course) · EG004: Part 2: Pembrolizumab + Chemotherapy (Second Course) · EG005: Part 2: Placebo + Chemotherapy

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
      num Events
      3
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      562
      num Events
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      281
      num Events
      8
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      2
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      562
      num Events
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      281
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      562
      num Events
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      562
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      562
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Myelosuppression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      562
      num Events
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      281
      num Events
      4
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      562
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      281
      num Events
      1
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      562
      num Events
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      281
      num Events
      7
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      562
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Thrombotic microangiopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      562
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      562
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Arrhythmia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      562
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Atrial fibrillation

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 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      10
      num Events
      15
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      11
      num Events
      12
    4. group Id
      EG003
      num Affected
      294
      num At Risk
      562
      num Events
      633
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      12
      num Events
      22
    6. group Id
      EG005
      num Affected
      140
      num At Risk
      281
      num Events
      258
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
      num Events
      64
    4. group Id
      EG003
      num Affected
      111
      num At Risk
      562
      num Events
      461
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      50
      num At Risk
      281
      num Events
      158
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      562
      num Events
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      281
      num Events
      15
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      21
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      11
      num Events
      90
    4. group Id
      EG003
      num Affected
      232
      num At Risk
      562
      num Events
      936
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      12
      num Events
      4
    6. group Id
      EG005
      num Affected
      109
      num At Risk
      281
      num Events
      384
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      11
      num Events
      89
    4. group Id
      EG003
      num Affected
      110
      num At Risk
      562
      num Events
      346
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      56
      num At Risk
      281
      num Events
      155
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      562
      num Events
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      281
      num Events
      3
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      562
      num Events
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      281
      num Events
      13
    term
    Vertigo
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      562
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Adrenal insufficiency
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      562
      num Events
      25
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      281
      num Events
      4
    term
    Hyperthyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      562
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Hypophysitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      11
      num Events
      5
    4. group Id
      EG003
      num Affected
      85
      num At Risk
      562
      num Events
      96
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      281
      num Events
      10
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      562
      num Events
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Thyroiditis
Complete source fields
description
All-cause mortality population: All participants in the treatment arm to which they were randomly assigned. AE population: All participants who received at least 1 dose of study intervention corresponding to the study intervention actually received. 4 participants assigned to the pembrolizumab + paclitaxel group received incorrect chemotherapy in error. Per protocol, "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded..
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    11
    description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    3
    serious Num At Risk
    13
    title
    Part 1: Pembrolizumab + Nab-Paclitaxel
  2. deaths Num Affected
    12
    deaths Num At Risk
    14
    description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle.
    id
    EG001
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    4
    serious Num At Risk
    10
    title
    Part 1: Pembrolizumab + Paclitaxel
  3. deaths Num Affected
    9
    deaths Num At Risk
    10
    description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
    id
    EG002
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    9
    serious Num At Risk
    11
    title
    Part 1: Pembrolizumab + Gemcitabine/Carboplatin
  4. deaths Num Affected
    484
    deaths Num At Risk
    566
    description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle. Qualified participants who received first course of pembrolizumab but continued to experience disease progression were eligible to initiate a second course of pembrolizumab IV Q3W for up to 17 administrations (up to \~1 year).
    id
    EG003
    other Num Affected
    551
    other Num At Risk
    562
    serious Num Affected
    169
    serious Num At Risk
    562
    title
    Part 2: Pembrolizumab + Chemotherapy (First Course)
  5. deaths Num Affected
    5
    deaths Num At Risk
    12
    description
    Eligible participants received up to 17 additional administrations (up to approximately 1year) of pembrolizumab 200 mg IV on day 1 of each 21-day cycle.
    id
    EG004
    other Num Affected
    11
    other Num At Risk
    12
    serious Num Affected
    3
    serious Num At Risk
    12
    title
    Part 2: Pembrolizumab + Chemotherapy (Second Course)
  6. deaths Num Affected
    249
    deaths Num At Risk
    281
    description
    Participants received placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle
    id
    EG005
    other Num Affected
    273
    other Num At Risk
    281
    serious Num Affected
    68
    serious Num At Risk
    281
    title
    Part 2: Placebo + Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      13
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      10
      num Events
      15
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      11
      num Events
      12
    4. group Id
      EG003
      num Affected
      294
      num At Risk
      562
      num Events
      633
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      12
      num Events
      22
    6. group Id
      EG005
      num Affected
      140
      num At Risk
      281
      num Events
      258
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
      num Events
      64
    4. group Id
      EG003
      num Affected
      111
      num At Risk
      562
      num Events
      461
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      50
      num At Risk
      281
      num Events
      158
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      30
      num At Risk
      562
      num Events
      62
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      281
      num Events
      15
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      21
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      11
      num Events
      90
    4. group Id
      EG003
      num Affected
      232
      num At Risk
      562
      num Events
      936
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      12
      num Events
      4
    6. group Id
      EG005
      num Affected
      109
      num At Risk
      281
      num Events
      384
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      11
      num Events
      89
    4. group Id
      EG003
      num Affected
      110
      num At Risk
      562
      num Events
      346
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      56
      num At Risk
      281
      num Events
      155
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      562
      num Events
      11
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      281
      num Events
      3
    term
    Tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      562
      num Events
      22
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      12
      num At Risk
      281
      num Events
      13
    term
    Vertigo
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      562
      num Events
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Adrenal insufficiency
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      562
      num Events
      25
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      281
      num Events
      4
    term
    Hyperthyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      562
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Hypophysitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      3
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      11
      num Events
      5
    4. group Id
      EG003
      num Affected
      85
      num At Risk
      562
      num Events
      96
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      281
      num Events
      10
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      562
      num Events
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Thyroiditis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      11
      num Events
      3
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      562
      num Events
      12
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      281
      num Events
      8
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      2
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      562
      num Events
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      281
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      562
      num Events
      6
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      562
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      562
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Myelosuppression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      562
      num Events
      7
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      281
      num Events
      4
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      562
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      281
      num Events
      1
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      11
      num Events
      1
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      562
      num Events
      14
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      281
      num Events
      7
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      562
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Thrombotic microangiopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      562
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      562
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Arrhythmia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      11
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      562
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      12
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      281
      num Events
      0
    term
    Atrial fibrillation
time Frame
Up to approximately 81 months

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

Preserved source evidence · Not medical advice