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NCT02563002 · ADVERSE EVENTS

Adverse events

Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177) · Source last updated 2024-10-03

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 91 months
Other-event reporting threshold
5%

All-cause mortality (ACM)=all randomized participants. AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment are excluded. Per protocol, collection of AEs and ACM were planned to be done in first and second courses.

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

Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years).

62 / 153145 / 15368 / 153
Standard of Care (SOC) First Course

Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle.

76 / 143142 / 14358 / 154
SOC Switched Over to Pembrolizumab

Eligible participants with documented disease progression following chemotherapy in SOC arm switched over to receive pembrolizumab for up to 35 cycles (approximately 2 years).

27 / 5753 / 5730 / 57
Pembrolizumab Second Course

Participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).

3 / 1211 / 124 / 12
SOC Switched Over to Pembrolizumab-Second Course

Participants who switched over from SOC and received pembrolizumab and subsequently stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).

1 / 54 / 52 / 5

Group identifiers: EG000: Pembrolizumab First Course · EG001: Standard of Care (SOC) First Course · EG002: SOC Switched Over to Pembrolizumab · EG003: Pembrolizumab Second Course · EG004: SOC 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
      1
      num At Risk
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      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
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      143
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Febrile neutropenia
  3. 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
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Leukocytosis
  4. 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
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      143
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    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
      1
      num At Risk
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Acute coronary syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Angina pectoris
  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
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Atrial fibrillation
  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
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Supraventricular tachycardia

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
      26
      num At Risk
      153
      num Events
      32
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      143
      num Events
      40
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      57
      num Events
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      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
      0
      num At Risk
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      143
      num Events
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    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
      0
      num At Risk
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      57
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      153
      num Events
      4
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      143
      num Events
      52
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    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
      1
      num At Risk
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      143
      num Events
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      153
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      153
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Hyperthyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      153
      num Events
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      143
      num Events
      6
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      57
      num Events
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      153
      num Events
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      143
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Dry eye
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      153
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      57
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Ocular hyperaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      153
      num Events
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Vision blurred
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      153
      num Events
      56
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      143
      num Events
      62
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      57
      num Events
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal pain
Complete source fields
description
All-cause mortality (ACM)=all randomized participants. AEs=all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an AE unless related to treatment. Medical Dictionary for Regulatory Activities (MedDRA) terms neoplasm progression (NP), malignant NP, and disease progression not related to treatment are excluded. Per protocol, collection of AEs and ACM were planned to be done in first and second courses.
event Groups
  1. deaths Num Affected
    68
    deaths Num At Risk
    153
    description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years).
    id
    EG000
    other Num Affected
    145
    other Num At Risk
    153
    serious Num Affected
    62
    serious Num At Risk
    153
    title
    Pembrolizumab First Course
  2. deaths Num Affected
    58
    deaths Num At Risk
    154
    description
    Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m\^2 IV over 2 hours then 250 mg/m\^2 over 1 hour weekly in each 2-week cycle.
    id
    EG001
    other Num Affected
    142
    other Num At Risk
    143
    serious Num Affected
    76
    serious Num At Risk
    143
    title
    Standard of Care (SOC) First Course
  3. deaths Num Affected
    30
    deaths Num At Risk
    57
    description
    Eligible participants with documented disease progression following chemotherapy in SOC arm switched over to receive pembrolizumab for up to 35 cycles (approximately 2 years).
    id
    EG002
    other Num Affected
    53
    other Num At Risk
    57
    serious Num Affected
    27
    serious Num At Risk
    57
    title
    SOC Switched Over to Pembrolizumab
  4. deaths Num Affected
    4
    deaths Num At Risk
    12
    description
    Participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
    id
    EG003
    other Num Affected
    11
    other Num At Risk
    12
    serious Num Affected
    3
    serious Num At Risk
    12
    title
    Pembrolizumab Second Course
  5. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    Participants who switched over from SOC and received pembrolizumab and subsequently stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).
    id
    EG004
    other Num Affected
    4
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    SOC 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
      26
      num At Risk
      153
      num Events
      32
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      143
      num Events
      40
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      57
      num Events
      18
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      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
      0
      num At Risk
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      143
      num Events
      12
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    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
      0
      num At Risk
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      57
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Lymphadenopathy
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      153
      num Events
      4
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      143
      num Events
      52
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    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
      1
      num At Risk
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      143
      num Events
      18
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      153
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Atrial fibrillation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      153
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Hyperthyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      153
      num Events
      20
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      143
      num Events
      6
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      57
      num Events
      7
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      12
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      153
      num Events
      11
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      143
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      12
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Dry eye
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      153
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      57
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Ocular hyperaemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      153
      num Events
      8
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Vision blurred
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      153
      num Events
      56
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      143
      num Events
      62
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      57
      num Events
      12
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      12
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Abdominal pain
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
      1
      num At Risk
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      143
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      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
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      143
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Febrile neutropenia
  3. 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
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Leukocytosis
  4. 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
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      143
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    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
      1
      num At Risk
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Acute coronary syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Angina pectoris
  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
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      143
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Atrial fibrillation
  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
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      153
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      153
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      143
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      57
      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
      5
      num Events
      0
    term
    Supraventricular tachycardia
time Frame
Up to approximately 91 months

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Preserved source evidence · Independent clinical review pending · Not medical advice