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NCT02775435 · ADVERSE EVENTS

Adverse events

A Study of Carboplatin-Paclitaxel/Nab-Paclitaxel Chemotherapy With or Without Pembrolizumab (MK-3475) in Adults With First Line Metastatic Squamous Non-small Cell Lung Cancer (MK-3475-407/KEYNOTE-407) · Source last updated 2024-10-08

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 83 months
Other-event reporting threshold
5%

All-Cause Mortality (ACM): all randomized participants. AEs: 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; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pembrolizumab + Chemotherapy Combo

Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.

128 / 278270 / 278225 / 278
Placebo + Chemotherapy

Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.

114 / 280272 / 280143 / 281
Placebo Switched Over to Pembrolizumab

Participants who received saline placebo with chemotherapy and who experienced disease progression, switched over to receive pembrolizumab monotherapy at investigator's discretion. Pembrolizumab was administered at 200 mg IV on Day 1 of each 21-day cycle for 35 cycles (\~ 2 years).

35 / 11890 / 118111 / 118
Pembrolizumab Combo (Second Course)

Participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) and were deemed to be benefitting clinically despite progression, received a second course of pembrolizumab at the investigator's discretion. Pembrolizumab was administered at 200 mg IV on Day 1 of each 21-day cycle for up to 17 cycles (up to \~1 year additional).

2 / 129 / 126 / 12
Placebo Switched Over to Pembrolizumab (Second Course)

Participants who switched from saline placebo to complete the first course of up to 35 administrations of pembrolizumab (\~2 years), initiated a second course of pembrolizumab at investigator's discretion. Pembrolizumab was administered 200 mg IV on Day 1 of each 21-day cycle for up to 17 cycles (up to \~1 year).

0 / 10 / 10 / 1

Group identifiers: EG000: Pembrolizumab + Chemotherapy Combo · EG001: Placebo + Chemotherapy · EG002: Placebo Switched Over to Pembrolizumab · EG003: Pembrolizumab Combo (Second Course) · EG004: Placebo Switched Over to Pembrolizumab (Second Course)

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      278
      num Events
      5
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      280
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      118
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Eosinophilia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      278
      num Events
      15
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      280
      num Events
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      278
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      278
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      280
      num Events
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      278
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      118
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Splenic haematoma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      278
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      280
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      278
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      118
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      278
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      280
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Atrial flutter

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 26.0
    stats
    1. group Id
      EG000
      num Affected
      148
      num At Risk
      278
      num Events
      200
    2. group Id
      EG001
      num Affected
      139
      num At Risk
      280
      num Events
      186
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      118
      num Events
      26
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      278
      num Events
      46
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      280
      num Events
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      118
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      278
      num Events
      201
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      280
      num Events
      166
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      278
      num Events
      131
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      280
      num Events
      95
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      118
      num Events
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      278
      num Events
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      280
      num Events
      2
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      118
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      278
      num Events
      36
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      280
      num Events
      7
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      118
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      278
      num Events
      24
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      280
      num Events
      17
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      118
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      278
      num Events
      93
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      280
      num Events
      74
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      118
      num Events
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      278
      num Events
      141
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      280
      num Events
      86
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      118
      num Events
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      278
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      280
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      118
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      278
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      280
      num Events
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      118
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      278
      num Events
      151
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      280
      num Events
      136
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      118
      num Events
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Nausea
Complete source fields
description
All-Cause Mortality (ACM): all randomized participants. AEs: 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; MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" unrelated to study drug are excluded as AEs. Per protocol, participants receiving switch-over, second course, and switch-over plus second course treatment were monitored for ACM and AEs separately.
event Groups
  1. deaths Num Affected
    225
    deaths Num At Risk
    278
    description
    Participants received pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of 21-day cycle for up to 35 cycles PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin Area Under Curve (AUC) 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
    id
    EG000
    other Num Affected
    270
    other Num At Risk
    278
    serious Num Affected
    128
    serious Num At Risk
    278
    title
    Pembrolizumab + Chemotherapy Combo
  2. deaths Num Affected
    143
    deaths Num At Risk
    281
    description
    Participants received normal saline as placebo by IV infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles (\~ 2 years) PLUS Investigator's choice of paclitaxel (200 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles) or nab-paclitaxel (100 mg/m\^2 by IV infusion on Days 1, 8, 15 of each 21-day cycle for 4 cycles) PLUS carboplatin AUC 6 by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
    id
    EG001
    other Num Affected
    272
    other Num At Risk
    280
    serious Num Affected
    114
    serious Num At Risk
    280
    title
    Placebo + Chemotherapy
  3. deaths Num Affected
    111
    deaths Num At Risk
    118
    description
    Participants who received saline placebo with chemotherapy and who experienced disease progression, switched over to receive pembrolizumab monotherapy at investigator's discretion. Pembrolizumab was administered at 200 mg IV on Day 1 of each 21-day cycle for 35 cycles (\~ 2 years).
    id
    EG002
    other Num Affected
    90
    other Num At Risk
    118
    serious Num Affected
    35
    serious Num At Risk
    118
    title
    Placebo Switched Over to Pembrolizumab
  4. deaths Num Affected
    6
    deaths Num At Risk
    12
    description
    Participants who completed the first course of up to 35 administrations of pembrolizumab (\~2 years) and were deemed to be benefitting clinically despite progression, received a second course of pembrolizumab at the investigator's discretion. Pembrolizumab was administered at 200 mg IV on Day 1 of each 21-day cycle for up to 17 cycles (up to \~1 year additional).
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    12
    serious Num Affected
    2
    serious Num At Risk
    12
    title
    Pembrolizumab Combo (Second Course)
  5. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participants who switched from saline placebo to complete the first course of up to 35 administrations of pembrolizumab (\~2 years), initiated a second course of pembrolizumab at investigator's discretion. Pembrolizumab was administered 200 mg IV on Day 1 of each 21-day cycle for up to 17 cycles (up to \~1 year).
    id
    EG004
    other Num Affected
    0
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Placebo Switched Over to Pembrolizumab (Second Course)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      148
      num At Risk
      278
      num Events
      200
    2. group Id
      EG001
      num Affected
      139
      num At Risk
      280
      num Events
      186
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      118
      num Events
      26
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      278
      num Events
      46
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      280
      num Events
      40
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      118
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      278
      num Events
      201
    2. group Id
      EG001
      num Affected
      85
      num At Risk
      280
      num Events
      166
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      278
      num Events
      131
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      280
      num Events
      95
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      118
      num Events
      6
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      278
      num Events
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      280
      num Events
      2
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      118
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      278
      num Events
      36
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      280
      num Events
      7
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      118
      num Events
      6
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      278
      num Events
      24
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      280
      num Events
      17
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      118
      num Events
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      278
      num Events
      93
    2. group Id
      EG001
      num Affected
      62
      num At Risk
      280
      num Events
      74
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      118
      num Events
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      88
      num At Risk
      278
      num Events
      141
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      280
      num Events
      86
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      118
      num Events
      22
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      278
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      280
      num Events
      3
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      118
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dry mouth
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      278
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      280
      num Events
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      118
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      101
      num At Risk
      278
      num Events
      151
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      280
      num Events
      136
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      118
      num Events
      13
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      278
      num Events
      5
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      280
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      118
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Eosinophilia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      278
      num Events
      15
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      280
      num Events
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      278
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      278
      num Events
      8
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      280
      num Events
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      278
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      118
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Splenic haematoma
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      278
      num Events
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      280
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      278
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      118
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      278
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      280
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      278
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      280
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      118
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      1
      num Events
      0
    term
    Atrial flutter
time Frame
Up to approximately 83 months

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Preserved source evidence · Not medical advice