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NCT01625234 · ADVERSE EVENTS

Adverse events

Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer · Source last updated 2026-04-30

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 first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)
Other-event reporting threshold
5%

AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase I: X-396 (Ensartinib) at 25 mg

Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor

1 / 43 / 40 / 4
Phase I: X-396 (Ensartinib) at 50 mg

Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor

1 / 33 / 30 / 3
Phase I: X-396 (Ensartinib) at 100 mg

Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor

2 / 54 / 51 / 5
Phase I: X-396 (Ensartinib) at 200 mg

Dose escalation starting at 200 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor

6 / 119 / 111 / 11
Phase I: X-396 (Ensartinib) at 225 mg

Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor

2 / 42 / 40 / 4
Phase I: X-396 (Ensartinib) at 250 mg

Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor

5 / 109 / 100 / 10
Phase II: X-396 (Ensartinib) at 225 mg

Dose expansion starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase II: X-396 (ensartinib): Oral, ALK inhibitor

41 / 9484 / 943 / 94

Group identifiers: EG000: Phase I: X-396 (Ensartinib) at 25 mg · EG001: Phase I: X-396 (Ensartinib) at 50 mg · EG002: Phase I: X-396 (Ensartinib) at 100 mg · EG003: Phase I: X-396 (Ensartinib) at 200 mg · EG004: Phase I: X-396 (Ensartinib) at 225 mg · EG005: Phase I: X-396 (Ensartinib) at 250 mg · EG006: Phase II: X-396 (Ensartinib) at 225 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
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      94
      num Events
      4
    term
    Pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      94
      num Events
      3
    term
    Blood and lymphatic system
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      94
      num Events
      2
    term
    Anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
      num Events
      1
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      94
      num Events
      7
    term
    Cardiac disorders
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      94
      num Events
      3
    term
    Pericardial effusion
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      94
      num Events
      1
    term
    Acute myocardial infraction
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      94
      num Events
      2
    term
    Atrial fibrilation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      94
      num Events
      4
    term
    Sepsis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      94
      num Events
      1
    term
    Cellulitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      94
      num Events
      1
    term
    Lung infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      94
      num Events
      3
    term
    Metabolism and connective tissue disorders
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      94
      num Events
      3
    term
    Dehydration

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 (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      94
      num Events
      11
    term
    Blood and lymphatic
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      8
      num At Risk
      94
      num Events
      8
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
      num Events
      2
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      11
      num Events
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      10
      num Events
      5
    7. group Id
      EG006
      num Affected
      57
      num At Risk
      94
      num Events
      57
    term
    Gastrointestinal disorders
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
      num Events
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      10
      num Events
      3
    7. group Id
      EG006
      num Affected
      36
      num At Risk
      94
      num Events
      36
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      11
      num Events
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      10
      num Events
      5
    7. group Id
      EG006
      num Affected
      24
      num At Risk
      94
      num Events
      24
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      94
      num Events
      9
    term
    Blood Creatinine increased
Complete source fields
description
AEs were recorded for each patient from their first dose of trial drug treatment. An event occurring after the patient has provided informed consent but before the first dose of study medication will be collected as part of the medical history. AEs were collected for all 131 patients who were dosed with study drug.All-cause Mortality: From first dose of study drug up to end of the study (approximately up to 57 months).
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Dose escalation starting at 25 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Phase I: X-396 (Ensartinib) at 25 mg
  2. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Dose escalation starting at 50 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    Phase I: X-396 (Ensartinib) at 50 mg
  3. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    Dose escalation starting at 100 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    5
    serious Num Affected
    2
    serious Num At Risk
    5
    title
    Phase I: X-396 (Ensartinib) at 100 mg
  4. deaths Num Affected
    1
    deaths Num At Risk
    11
    description
    Dose escalation starting at 200 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    11
    serious Num Affected
    6
    serious Num At Risk
    11
    title
    Phase I: X-396 (Ensartinib) at 200 mg
  5. deaths Num Affected
    0
    deaths Num At Risk
    4
    description
    Dose escalation starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    id
    EG004
    other Num Affected
    2
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    Phase I: X-396 (Ensartinib) at 225 mg
  6. deaths Num Affected
    0
    deaths Num At Risk
    10
    description
    Dose escalation starting at 250 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase I: X-396 (ensartinib): Oral, ALK inhibitor
    id
    EG005
    other Num Affected
    9
    other Num At Risk
    10
    serious Num Affected
    5
    serious Num At Risk
    10
    title
    Phase I: X-396 (Ensartinib) at 250 mg
  7. deaths Num Affected
    3
    deaths Num At Risk
    94
    description
    Dose expansion starting at 225 mg, oral once or twice a day, 28-day cycle. Number of Cycles: until progression or unacceptable toxicity develops Phase II: X-396 (ensartinib): Oral, ALK inhibitor
    id
    EG006
    other Num Affected
    84
    other Num At Risk
    94
    serious Num Affected
    41
    serious Num At Risk
    94
    title
    Phase II: X-396 (Ensartinib) at 225 mg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      11
      num At Risk
      94
      num Events
      11
    term
    Blood and lymphatic
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      8
      num At Risk
      94
      num Events
      8
    term
    Anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      5
      num Events
      2
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      11
      num Events
      6
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      10
      num Events
      5
    7. group Id
      EG006
      num Affected
      57
      num At Risk
      94
      num Events
      57
    term
    Gastrointestinal disorders
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      11
      num Events
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      10
      num Events
      3
    7. group Id
      EG006
      num Affected
      36
      num At Risk
      94
      num Events
      36
    term
    Nausea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      11
      num Events
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      4
      num Events
      1
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      10
      num Events
      5
    7. group Id
      EG006
      num Affected
      24
      num At Risk
      94
      num Events
      24
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      9
      num At Risk
      94
      num Events
      9
    term
    Blood Creatinine increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      94
      num Events
      4
    term
    Pneumonia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      94
      num Events
      3
    term
    Blood and lymphatic system
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      94
      num Events
      2
    term
    Anaemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
      num Events
      1
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      94
      num Events
      7
    term
    Cardiac disorders
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      94
      num Events
      3
    term
    Pericardial effusion
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      94
      num Events
      1
    term
    Acute myocardial infraction
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      11
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      94
      num Events
      2
    term
    Atrial fibrilation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      94
      num Events
      4
    term
    Sepsis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      11
      num Events
      2
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      94
      num Events
      1
    term
    Cellulitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      94
      num Events
      1
    term
    Lung infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      11
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      94
      num Events
      3
    term
    Metabolism and connective tissue disorders
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA (15.0)
    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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      11
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      4
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      94
      num Events
      3
    term
    Dehydration
time Frame
From first dose up to 30 days after the last dose of Ensartinib (up to 228 weeks)

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Preserved source evidence · Not medical advice