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NCT02812706 · ADVERSE EVENTS

Adverse events

Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients · Source last updated 2024-04-01

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
AE data was collected from first dose of study drug up to 30 days after last dose of study drug administration (maximum duration of exposure: up to 112 weeks for Cohort 1, and 137 weeks for Cohort 2 for Phase 1 part; and up to 248 weeks for Phase 2 part)
Other-event reporting threshold
5%

All-Cause Mortality data collected during the study was assessed for all enrolled participants. Serious and Other Adverse Events were collected for safety population only (i.e., all participants who gave their informed consent and received at least one dose \[even incomplete\] of isatuximab).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1, Cohort 1: Isatuximab 10 mg/kg

Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).

1 / 33 / 31 / 3
Phase 1, Cohort 2: Isatuximab 20 mg/kg

Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).

2 / 54 / 52 / 5
Phase 2: Isatuximab 20 mg/kg

Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).

11 / 2824 / 2810 / 28

Group identifiers: EG000: Phase 1, Cohort 1: Isatuximab 10 mg/kg · EG001: Phase 1, Cohort 2: Isatuximab 20 mg/kg · EG002: Phase 2: Isatuximab 20 mg/kg

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 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Disseminated Intravascular Coagulation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      2
    term
    Cataract
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Ileus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Large Intestine Polyp
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Disease Progression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Non-Cardiac Chest Pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Anal Abscess
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Intervertebral Discitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Lung Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Diabetic Ketoacidosis

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
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Conjunctivitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Hand-Foot-And-Mouth Disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    term
    Herpes Zoster
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Infected Dermal Cyst
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
      num Events
      3
    term
    Influenza
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      28
      num Events
      17
    term
    Nasopharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      4
    term
    Pharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Sinusitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Upper Respiratory Tract Infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Anaemia
Complete source fields
description
All-Cause Mortality data collected during the study was assessed for all enrolled participants. Serious and Other Adverse Events were collected for safety population only (i.e., all participants who gave their informed consent and received at least one dose \[even incomplete\] of isatuximab).
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants received Isatuximab 10 mg/kg IV infusion QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 112 weeks).
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase 1, Cohort 1: Isatuximab 10 mg/kg
  2. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 137 weeks).
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Phase 1, Cohort 2: Isatuximab 20 mg/kg
  3. deaths Num Affected
    10
    deaths Num At Risk
    28
    description
    Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).
    id
    EG002
    other Num Affected
    24
    other Num At Risk
    28
    serious Num Affected
    11
    serious Num At Risk
    28
    title
    Phase 2: Isatuximab 20 mg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Conjunctivitis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Hand-Foot-And-Mouth Disease
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    term
    Herpes Zoster
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Infected Dermal Cyst
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      28
      num Events
      3
    term
    Influenza
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      28
      num Events
      17
    term
    Nasopharyngitis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      4
    term
    Pharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Pneumonia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Sinusitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Upper Respiratory Tract Infection
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Anaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Disseminated Intravascular Coagulation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      2
    term
    Cataract
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Ileus
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Large Intestine Polyp
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      28
      num Events
      0
    term
    Disease Progression
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Non-Cardiac Chest Pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Anal Abscess
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Intervertebral Discitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Lung Infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      28
      num Events
      2
    term
    Pneumonia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Sinusitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      28
      num Events
      1
    term
    Diabetic Ketoacidosis
time Frame
AE data was collected from first dose of study drug up to 30 days after last dose of study drug administration (maximum duration of exposure: up to 112 weeks for Cohort 1, and 137 weeks for Cohort 2 for Phase 1 part; and up to 248 weeks for Phase 2 part)

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