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NCT04148937 · ADVERSE EVENTS

Adverse events

A Study of the CD73 Inhibitor LY3475070 Alone or in Combination With Pembrolizumab in Participants With Advanced Cancer · Source last updated 2024-04-05

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
Baseline up to 10.4 months
Other-event reporting threshold
0%

All enrolled participants in phase1a who received at least one dose of LY3475070. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort A - 150mg QD LY3475070

Participants received 150 milligrams (mg) LY3475070 orally once daily (QD) on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

0 / 44 / 44 / 4
Cohort A - 300mg QD LY3475070

Participants received 300mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

0 / 66 / 65 / 6
Cohort A - 300mg BID LY3475070

Participants received 300mg LY3475070 orally twice daily (BID) on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

0 / 66 / 61 / 6
Cohort A - 600mg QD LY3475070

Participants received 600mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

2 / 44 / 42 / 4
Cohort B - 150mg QD LY3475070 + Pembrolizumab

Participants received 150mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

1 / 32 / 31 / 3
Cohort B - 150mg BID LY3475070 + Pembrolizumab

Participants received 150mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

3 / 1111 / 113 / 11
Cohort B - 300mg QD LY3475070 + Pembrolizumab

Participants received 300mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.

1 / 11 / 10 / 1
Cohort B - 300mg BID LY3475070 + Pembrolizumab

Participants received 300mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study

7 / 1716 / 173 / 17

Group identifiers: EG000: Cohort A - 150mg QD LY3475070 · EG001: Cohort A - 300mg QD LY3475070 · EG002: Cohort A - 300mg BID LY3475070 · EG003: Cohort A - 600mg QD LY3475070 · EG004: Cohort B - 150mg QD LY3475070 + Pembrolizumab · EG005: Cohort B - 150mg BID LY3475070 + Pembrolizumab · EG006: Cohort B - 300mg QD LY3475070 + Pembrolizumab · EG007: Cohort B - 300mg BID LY3475070 + Pembrolizumab

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 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Supraventricular tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Small intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Liver injury
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Covid-19
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pneumonia

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 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      17
      num Events
      11
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Eye irritation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Eye pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Abdominal discomfort
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      17
      num Events
      4
    term
    Abdominal pain
Complete source fields
description
All enrolled participants in phase1a who received at least one dose of LY3475070. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    4
    description
    Participants received 150 milligrams (mg) LY3475070 orally once daily (QD) on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Cohort A - 150mg QD LY3475070
  2. deaths Num Affected
    5
    deaths Num At Risk
    6
    description
    Participants received 300mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    EG001
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Cohort A - 300mg QD LY3475070
  3. deaths Num Affected
    1
    deaths Num At Risk
    6
    description
    Participants received 300mg LY3475070 orally twice daily (BID) on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    EG002
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Cohort A - 300mg BID LY3475070
  4. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Participants received 600mg LY3475070 orally once daily on a 21-day cycle until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Cohort A - 600mg QD LY3475070
  5. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants received 150mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    EG004
    other Num Affected
    2
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Cohort B - 150mg QD LY3475070 + Pembrolizumab
  6. deaths Num Affected
    3
    deaths Num At Risk
    11
    description
    Participants received 150mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    EG005
    other Num Affected
    11
    other Num At Risk
    11
    serious Num Affected
    3
    serious Num At Risk
    11
    title
    Cohort B - 150mg BID LY3475070 + Pembrolizumab
  7. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Participants received 300mg LY3475070 orally once daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study discontinuation is met.
    id
    EG006
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    1
    serious Num At Risk
    1
    title
    Cohort B - 300mg QD LY3475070 + Pembrolizumab
  8. deaths Num Affected
    3
    deaths Num At Risk
    17
    description
    Participants received 300mg LY3475070 orally twice daily on a 21-day cycle in combination with an intravenous infusion of 200mg pembrolizumab on day 1 until progressive disease, unacceptable toxicity or other criterion for study
    id
    EG007
    other Num Affected
    16
    other Num At Risk
    17
    serious Num Affected
    7
    serious Num At Risk
    17
    title
    Cohort B - 300mg BID LY3475070 + Pembrolizumab
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      6
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      2
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      7
      num At Risk
      17
      num Events
      11
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      6
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Palpitations
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Sinus tachycardia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Eye irritation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Eye pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Abdominal discomfort
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Abdominal distension
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      6
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      6
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      17
      num Events
      4
    term
    Abdominal pain
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      1
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Supraventricular tachycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Small intestinal obstruction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      11
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Liver injury
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      17
      num Events
      0
    term
    Covid-19
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 25.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      6
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      11
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      1
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      17
      num Events
      1
    term
    Pneumonia
time Frame
Baseline up to 10.4 months

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Preserved source evidence · Not medical advice