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NCT03735121 · ADVERSE EVENTS

Adverse events

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer · Source last updated 2025-12-05

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
From initiation of the study treatment up to approximately 69 months in Part 1 and up to approximately 44.7 months in Part 2
Other-event reporting threshold
5%

Safety-evaluable population=all participants who received at least one dose of atezolizumab (IV or SC), with participants grouped according to treatment received. HCPs who administered study treatment to participants were not enrolled in the study. To evaluate the HCPs' reported experience with administration of atezolizumab SC \& IV, they were asked to complete 2 questionnaires: HCP SC Versus IV Perspective \& HCP SC Perspective. No adverse event data were collected for the HCPs in this study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg

Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.

2 / 1313 / 134 / 13
Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg

Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.

4 / 1512 / 156 / 15
Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg

Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.

8 / 3931 / 3919 / 39
Part 2: Atezolizumab IV 1200 mg

Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.

35 / 12491 / 12497 / 124
Part 2: Atezolizumab SC 1875 mg

Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.

50 / 247204 / 247206 / 247

Group identifiers: EG000: Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg · EG001: Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg · EG002: Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg · EG003: Part 2: Atezolizumab IV 1200 mg · EG004: Part 2: Atezolizumab SC 1875 mg

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Splenic infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      247
      num Events
      0
    term
    Arrhythmia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Autoimmune myocarditis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      247
      num Events
      0
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      247
      num Events
      4
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      2
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      247
      num Events
      0
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      247
      num Events
      0
    term
    Colitis

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 version 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
      num Events
      8
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      39
      num Events
      16
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      124
      num Events
      30
    5. group Id
      EG004
      num Affected
      47
      num At Risk
      247
      num Events
      54
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      124
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      247
      num Events
      4
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      124
      num Events
      3
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      247
      num Events
      9
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      124
      num Events
      7
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      247
      num Events
      18
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Supraventricular tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      247
      num Events
      3
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      124
      num Events
      2
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      247
      num Events
      7
    term
    Hyperthyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      124
      num Events
      9
    5. group Id
      EG004
      num Affected
      21
      num At Risk
      247
      num Events
      25
    term
    Hypothyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      247
      num Events
      0
    term
    Periorbital oedema
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
      num Events
      1
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      247
      num Events
      12
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      247
      num Events
      0
    term
    Anal haemorrhage
Complete source fields
description
Safety-evaluable population=all participants who received at least one dose of atezolizumab (IV or SC), with participants grouped according to treatment received. HCPs who administered study treatment to participants were not enrolled in the study. To evaluate the HCPs' reported experience with administration of atezolizumab SC \& IV, they were asked to complete 2 questionnaires: HCP SC Versus IV Perspective \& HCP SC Perspective. No adverse event data were collected for the HCPs in this study.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    13
    description
    Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    2
    serious Num At Risk
    13
    title
    Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg
  2. deaths Num Affected
    6
    deaths Num At Risk
    15
    description
    Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    15
    serious Num Affected
    4
    serious Num At Risk
    15
    title
    Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg
  3. deaths Num Affected
    19
    deaths Num At Risk
    39
    description
    Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
    id
    EG002
    other Num Affected
    31
    other Num At Risk
    39
    serious Num Affected
    8
    serious Num At Risk
    39
    title
    Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg
  4. deaths Num Affected
    97
    deaths Num At Risk
    124
    description
    Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
    id
    EG003
    other Num Affected
    91
    other Num At Risk
    124
    serious Num Affected
    35
    serious Num At Risk
    124
    title
    Part 2: Atezolizumab IV 1200 mg
  5. deaths Num Affected
    206
    deaths Num At Risk
    247
    description
    Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
    id
    EG004
    other Num Affected
    204
    other Num At Risk
    247
    serious Num Affected
    50
    serious Num At Risk
    247
    title
    Part 2: Atezolizumab SC 1875 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
      num Events
      8
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      39
      num Events
      16
    4. group Id
      EG003
      num Affected
      21
      num At Risk
      124
      num Events
      30
    5. group Id
      EG004
      num Affected
      47
      num At Risk
      247
      num Events
      54
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      124
      num Events
      3
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      247
      num Events
      4
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      124
      num Events
      3
    5. group Id
      EG004
      num Affected
      8
      num At Risk
      247
      num Events
      9
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      124
      num Events
      7
    5. group Id
      EG004
      num Affected
      9
      num At Risk
      247
      num Events
      18
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Supraventricular tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      247
      num Events
      3
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      124
      num Events
      2
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      247
      num Events
      7
    term
    Hyperthyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      15
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      39
      num Events
      1
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      124
      num Events
      9
    5. group Id
      EG004
      num Affected
      21
      num At Risk
      247
      num Events
      25
    term
    Hypothyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      247
      num Events
      0
    term
    Periorbital oedema
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
      num Events
      1
    5. group Id
      EG004
      num Affected
      12
      num At Risk
      247
      num Events
      12
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      247
      num Events
      0
    term
    Anal haemorrhage
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Splenic infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      247
      num Events
      0
    term
    Arrhythmia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Autoimmune myocarditis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Cardiac arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      247
      num Events
      0
    term
    Cardiac failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      1
    term
    Cardiac failure congestive
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      247
      num Events
      4
    term
    Myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      247
      num Events
      2
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      247
      num Events
      0
    term
    Abdominal pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA version 27.1
    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
      15
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      39
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      247
      num Events
      0
    term
    Colitis
time Frame
From initiation of the study treatment up to approximately 69 months in Part 1 and up to approximately 44.7 months in Part 2

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