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NCT05070247 · ADVERSE EVENTS

Adverse events

A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors · Source last updated 2026-01-22

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 32.8 months
Other-event reporting threshold
5%

The Safety Analysis Set included all participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Single Agent Dose Escalation: TAK-500 8 µg/kg

Participants received TAK-500 dose escalation dose starting at 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (once every 2 weeks, Q2W), for up to 1 year.

3 / 33 / 31 / 3
Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) TOCI followed by TAK-500 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.

3 / 33 / 31 / 3
Single Agent Dose Escalation: TAK-500 16 µg/kg

Participants received 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.

4 / 55 / 51 / 5
Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg

Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.

2 / 33 / 31 / 3
Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.

2 / 33 / 30 / 3
Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500 16 µg/kg IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.

5 / 77 / 72 / 7
Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 24 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.

2 / 33 / 30 / 3
Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500 24 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.

2 / 22 / 20 / 2
Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 40 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.

3 / 66 / 62 / 6
Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 60 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.

4 / 44 / 41 / 4
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.

3 / 55 / 52 / 5
Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg

Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.

4 / 55 / 52 / 5
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.

6 / 77 / 72 / 7
Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg

Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.

4 / 55 / 50 / 5

Group identifiers: EG000: Single Agent Dose Escalation: TAK-500 8 µg/kg · EG001: Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg · EG002: Single Agent Dose Escalation: TAK-500 16 µg/kg · EG003: Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg · EG004: Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg · EG005: Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg · EG006: Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX · EG007: Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg · EG008: Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg · EG009: Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg · EG010: Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg · EG011: Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg · EG012: Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg · EG013: Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Bacteraemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Bronchial obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Cerebellar stroke
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      5
    term
    Cytokine release syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Decreased appetite
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Dehydration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Product Issues
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Device malfunction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Diarrhoea

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 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Acidosis hyperchloraemic
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Acne
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Activated partial thromboplastin time prolonged
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Acute kidney injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Acute respiratory failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      5
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Allergic cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Alopecia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Anaemia
Complete source fields
description
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants received TAK-500 dose escalation dose starting at 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (once every 2 weeks, Q2W), for up to 1 year.
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Single Agent Dose Escalation: TAK-500 8 µg/kg
  2. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) TOCI followed by TAK-500 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg
  3. deaths Num Affected
    1
    deaths Num At Risk
    5
    description
    Participants received 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
    id
    EG002
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    4
    serious Num At Risk
    5
    title
    Single Agent Dose Escalation: TAK-500 16 µg/kg
  4. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
    id
    EG003
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg
  5. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg
  6. deaths Num Affected
    2
    deaths Num At Risk
    7
    description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500 16 µg/kg IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
    id
    EG005
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg
  7. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 24 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.
    id
    EG006
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX
  8. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500 24 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.
    id
    EG007
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    2
    serious Num At Risk
    2
    title
    Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg
  9. deaths Num Affected
    2
    deaths Num At Risk
    6
    description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 40 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.
    id
    EG008
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    3
    serious Num At Risk
    6
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg
  10. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 60 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year.
    id
    EG009
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    4
    serious Num At Risk
    4
    title
    Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg
  11. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
    id
    EG010
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg
  12. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year.
    id
    EG011
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    4
    serious Num At Risk
    5
    title
    Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Abdominal pain upper
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Acidosis hyperchloraemic
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Acne
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Activated partial thromboplastin time prolonged
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Acute kidney injury
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Acute respiratory failure
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      4
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      2
      num At Risk
      5
    term
    Alanine aminotransferase increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Allergic cough
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Alopecia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      3
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      2
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Anaemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Alanine aminotransferase increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Bacteraemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Bronchial obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Cerebellar stroke
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      1
      num At Risk
      5
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      3
      num At Risk
      5
    term
    Cytokine release syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Decreased appetite
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      1
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Dehydration
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Product Issues
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Device malfunction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      5
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      3
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      7
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      3
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      2
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      6
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      4
    11. group Id
      EG010
      num Affected
      0
      num At Risk
      5
    12. group Id
      EG011
      num Affected
      0
      num At Risk
      5
    term
    Diarrhoea
time Frame
Up to approximately 32.8 months

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Preserved source evidence · Not medical advice