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NCT02903914 · ADVERSE EVENTS

Adverse events

Arginase Inhibitor INCB001158 as a Single Agent and in Combination With Immune Checkpoint Therapy in Patients With Advanced/Metastatic Solid Tumors · Source last updated 2025-08-05

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
up to approximately 3.5 years
Other-event reporting threshold
5%

For Adverse Event reporting, the data from Part 1C has been combined with that of Part 1B participants who received 50 mg INCB001158 + pembrolizumab.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1A: INCB001158 50 mg

INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.

3 / 87 / 80 / 8
Part 1A: INCB001158 75 mg

INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.

2 / 77 / 70 / 7
Part 1A and Part 2: INCB001158 100 mg

INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors

31 / 8577 / 8512 / 85
Part 1A: INCB001158 150 mg

INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.

0 / 77 / 70 / 7
Part 1B and Part 1C: INCB001158 50 mg + Pembrolizumab

INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W). Participants in Part 1C had moderately impaired renal function.

6 / 1616 / 163 / 16
Part 1B: INCB001158 75 mg + Pembrolizumab

INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.

5 / 1413 / 143 / 14
Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab

INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.

47 / 123116 / 12324 / 123
Total

Total

94 / 260243 / 26042 / 260

Group identifiers: EG000: Part 1A: INCB001158 50 mg · EG001: Part 1A: INCB001158 75 mg · EG002: Part 1A and Part 2: INCB001158 100 mg · EG003: Part 1A: INCB001158 150 mg · EG004: Part 1B and Part 1C: INCB001158 50 mg + Pembrolizumab · EG005: Part 1B: INCB001158 75 mg + Pembrolizumab · EG006: Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab · EG007: Total

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      123
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      85
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      123
      num Events
      7
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      260
      num Events
      13
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      123
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      85
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      123
      num Events
      2
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      260
      num Events
      4
    term
    Acute kidney injury
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      123
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Adrenal haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      123
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      260
      num Events
      2
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      123
      num Events
      4
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      260
      num Events
      4
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      123
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      260
      num Events
      2
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      123
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Asymptomatic bacteriuria
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      85
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      123
      num Events
      3
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      260
      num Events
      6
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      123
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Bacteraemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      123
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Blood alkaline phosphatase increased

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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      123
      num Events
      3
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      260
      num Events
      4
    term
    Abdominal discomfort
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      85
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      123
      num Events
      7
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      260
      num Events
      10
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      85
      num Events
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      123
      num Events
      3
    8. group Id
      EG007
      num Affected
      18
      num At Risk
      260
      num Events
      19
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      123
      num Events
      3
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      260
      num Events
      6
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      85
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      123
      num Events
      8
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      260
      num Events
      10
    term
    Activated partial thromboplastin time prolonged
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      123
      num Events
      2
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      260
      num Events
      3
    term
    Acute kidney injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      123
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Adrenal insufficiency
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      85
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      14
      num Events
      2
    7. group Id
      EG006
      num Affected
      21
      num At Risk
      123
      num Events
      25
    8. group Id
      EG007
      num Affected
      29
      num At Risk
      260
      num Events
      33
    term
    Alanine aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      8
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
      num Events
      4
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      85
      num Events
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    7. group Id
      EG006
      num Affected
      22
      num At Risk
      123
      num Events
      23
    8. group Id
      EG007
      num Affected
      41
      num At Risk
      260
      num Events
      45
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      123
      num Events
      3
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      260
      num Events
      6
    term
    Anxiety
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      123
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      260
      num Events
      2
    term
    Appetite disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      85
      num Events
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      14
      num Events
      2
    7. group Id
      EG006
      num Affected
      14
      num At Risk
      123
      num Events
      21
    8. group Id
      EG007
      num Affected
      30
      num At Risk
      260
      num Events
      39
    term
    Arthralgia
Complete source fields
description
For Adverse Event reporting, the data from Part 1C has been combined with that of Part 1B participants who received 50 mg INCB001158 + pembrolizumab.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    8
    description
    INCB001158 was administered orally at 50 milligrams (mg) twice daily (BID) in participants with advanced/metastatic solid tumors.
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    8
    serious Num Affected
    3
    serious Num At Risk
    8
    title
    Part 1A: INCB001158 50 mg
  2. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    INCB001158 was administered orally at 75 mg BID in participants with advanced/metastatic solid tumors.
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    2
    serious Num At Risk
    7
    title
    Part 1A: INCB001158 75 mg
  3. deaths Num Affected
    12
    deaths Num At Risk
    85
    description
    INCB001158 was administered orally at 100 mg BID in participants with advanced/metastatic solid tumors
    id
    EG002
    other Num Affected
    77
    other Num At Risk
    85
    serious Num Affected
    31
    serious Num At Risk
    85
    title
    Part 1A and Part 2: INCB001158 100 mg
  4. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    INCB001158 was administered orally at 150 mg BID in participants with advanced/metastatic solid tumors.
    id
    EG003
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    0
    serious Num At Risk
    7
    title
    Part 1A: INCB001158 150 mg
  5. deaths Num Affected
    3
    deaths Num At Risk
    16
    description
    INCB001158 was administered orally at 50 mg BID in combination with pembrolizumab at 200 mg intravenously (IV) every 3 weeks (Q3W). Participants in Part 1C had moderately impaired renal function.
    id
    EG004
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    6
    serious Num At Risk
    16
    title
    Part 1B and Part 1C: INCB001158 50 mg + Pembrolizumab
  6. deaths Num Affected
    3
    deaths Num At Risk
    14
    description
    INCB001158 was administered orally at 75 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
    id
    EG005
    other Num Affected
    13
    other Num At Risk
    14
    serious Num Affected
    5
    serious Num At Risk
    14
    title
    Part 1B: INCB001158 75 mg + Pembrolizumab
  7. deaths Num Affected
    24
    deaths Num At Risk
    123
    description
    INCB001158 was administered orally at 100 mg BID in combination with pembrolizumab at 200 mg IV Q3W.
    id
    EG006
    other Num Affected
    116
    other Num At Risk
    123
    serious Num Affected
    47
    serious Num At Risk
    123
    title
    Part 1B and Part 3: INCB001158 100 mg + Pembrolizumab
  8. deaths Num Affected
    42
    deaths Num At Risk
    260
    description
    Total
    id
    EG007
    other Num Affected
    243
    other Num At Risk
    260
    serious Num Affected
    94
    serious Num At Risk
    260
    title
    Total
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      123
      num Events
      3
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      260
      num Events
      4
    term
    Abdominal discomfort
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      85
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      123
      num Events
      7
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      260
      num Events
      10
    term
    Abdominal distension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      85
      num Events
      11
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
      num Events
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      123
      num Events
      3
    8. group Id
      EG007
      num Affected
      18
      num At Risk
      260
      num Events
      19
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      1
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      123
      num Events
      3
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      260
      num Events
      6
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      85
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      123
      num Events
      8
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      260
      num Events
      10
    term
    Activated partial thromboplastin time prolonged
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      123
      num Events
      2
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      260
      num Events
      3
    term
    Acute kidney injury
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      123
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Adrenal insufficiency
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      85
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
      num Events
      1
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      14
      num Events
      2
    7. group Id
      EG006
      num Affected
      21
      num At Risk
      123
      num Events
      25
    8. group Id
      EG007
      num Affected
      29
      num At Risk
      260
      num Events
      33
    term
    Alanine aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      8
      num Events
      4
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
      num Events
      4
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      85
      num Events
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
      num Events
      2
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      14
      num Events
      1
    7. group Id
      EG006
      num Affected
      22
      num At Risk
      123
      num Events
      23
    8. group Id
      EG007
      num Affected
      41
      num At Risk
      260
      num Events
      45
    term
    Anaemia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      7
      num Events
      1
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      123
      num Events
      3
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      260
      num Events
      6
    term
    Anxiety
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      123
      num Events
      0
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      260
      num Events
      2
    term
    Appetite disorder
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      85
      num Events
      12
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      7
      num Events
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      14
      num Events
      2
    7. group Id
      EG006
      num Affected
      14
      num At Risk
      123
      num Events
      21
    8. group Id
      EG007
      num Affected
      30
      num At Risk
      260
      num Events
      39
    term
    Arthralgia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      123
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      85
      num Events
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      4
      num At Risk
      123
      num Events
      7
    8. group Id
      EG007
      num Affected
      10
      num At Risk
      260
      num Events
      13
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      123
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      85
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      123
      num Events
      2
    8. group Id
      EG007
      num Affected
      4
      num At Risk
      260
      num Events
      4
    term
    Acute kidney injury
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      123
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Adrenal haemorrhage
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      123
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      260
      num Events
      2
    term
    Anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      123
      num Events
      4
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      260
      num Events
      4
    term
    Ascites
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      123
      num Events
      1
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      260
      num Events
      2
    term
    Aspartate aminotransferase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      123
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Asymptomatic bacteriuria
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      85
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      123
      num Events
      3
    8. group Id
      EG007
      num Affected
      6
      num At Risk
      260
      num Events
      6
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      85
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      123
      num Events
      1
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Bacteraemia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 19
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      85
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      7
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      14
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      123
      num Events
      0
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      260
      num Events
      1
    term
    Blood alkaline phosphatase increased
time Frame
up to approximately 3.5 years

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Preserved source evidence · Not medical advice