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NCT02669017 · ADVERSE EVENTS

Adverse events

Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL) · Source last updated 2021-05-19

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
Day 1 to End of Study (a maximum of 18 months)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part 1: 15 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).

1 / 44 / 41 / 4
Part 1: 30 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).

1 / 43 / 42 / 4
Part 1: 60 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).

0 / 44 / 42 / 4
Part 1: 90 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).

4 / 55 / 53 / 5
Part 1: 120 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).

4 / 1616 / 168 / 16
Part 2: 120 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).

4 / 2625 / 2618 / 26
Part 1: 150 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).

6 / 1919 / 1910 / 19
Part 2: 150 μg/kg Q3W

Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).

40 / 6965 / 6947 / 69
Part 1: 200 μg/kg Q3W and Q6W

Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).

15 / 3636 / 3620 / 36

Group identifiers: EG000: Part 1: 15 μg/kg Q3W · EG001: Part 1: 30 μg/kg Q3W · EG002: Part 1: 60 μg/kg Q3W · EG003: Part 1: 90 μg/kg Q3W · EG004: Part 1: 120 μg/kg Q3W · EG005: Part 2: 120 μg/kg Q3W · EG006: Part 1: 150 μg/kg Q3W · EG007: Part 2: 150 μg/kg Q3W · EG008: Part 1: 200 μg/kg Q3W and Q6W

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Pericardial effusion
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Cardiac arrest
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Supraventricular tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Hypothyroidism
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Abdominal pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Gastrointestinal haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Small intestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Abdominal compartment syndrome

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      25
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      14
      num At Risk
      36
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      17
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      10
      num At Risk
      36
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      13
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      9
      num At Risk
      36
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Leukopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      36
    term
    Pericardial effusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Atrial fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Periorbital oedema
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      36
    term
    Dry eye
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Visual impairment
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      22
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      16
      num At Risk
      36
    term
    Nausea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      18
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      6
      num At Risk
      36
    term
    Constipation
Complete source fields
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    Participants received an intravenous (IV) infusion of ADCT-402 (15 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    EG000
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Part 1: 15 μg/kg Q3W
  2. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Participants received an intravenous (IV) infusion of ADCT-402 (30 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    4
    serious Num Affected
    1
    serious Num At Risk
    4
    title
    Part 1: 30 μg/kg Q3W
  3. deaths Num Affected
    2
    deaths Num At Risk
    4
    description
    Participants received an intravenous (IV) infusion of ADCT-402 (60 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    EG002
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    0
    serious Num At Risk
    4
    title
    Part 1: 60 μg/kg Q3W
  4. deaths Num Affected
    3
    deaths Num At Risk
    5
    description
    Participants received an intravenous (IV) infusion of ADCT-402 (90 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    EG003
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    4
    serious Num At Risk
    5
    title
    Part 1: 90 μg/kg Q3W
  5. deaths Num Affected
    8
    deaths Num At Risk
    16
    description
    Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    EG004
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    4
    serious Num At Risk
    16
    title
    Part 1: 120 μg/kg Q3W
  6. deaths Num Affected
    18
    deaths Num At Risk
    26
    description
    Participants received an intravenous (IV) infusion of ADCT-402 (120 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    EG005
    other Num Affected
    25
    other Num At Risk
    26
    serious Num Affected
    4
    serious Num At Risk
    26
    title
    Part 2: 120 μg/kg Q3W
  7. deaths Num Affected
    10
    deaths Num At Risk
    19
    description
    Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    EG006
    other Num Affected
    19
    other Num At Risk
    19
    serious Num Affected
    6
    serious Num At Risk
    19
    title
    Part 1: 150 μg/kg Q3W
  8. deaths Num Affected
    47
    deaths Num At Risk
    69
    description
    Participants received an intravenous (IV) infusion of ADCT-402 (150 μg/kg) on Day 1 of each 3 week cycle (Q3W).
    id
    EG007
    other Num Affected
    65
    other Num At Risk
    69
    serious Num Affected
    40
    serious Num At Risk
    69
    title
    Part 2: 150 μg/kg Q3W
  9. deaths Num Affected
    20
    deaths Num At Risk
    36
    description
    Participants received an intravenous (IV) infusion of ADCT-402 (200 μg/kg) on Day 1 of each 3 week cycle (Q3W). Following protocol amendment 5, treatment cycle length was increased to 6 weeks (Q6W).
    id
    EG008
    other Num Affected
    36
    other Num At Risk
    36
    serious Num Affected
    15
    serious Num At Risk
    36
    title
    Part 1: 200 μg/kg Q3W and Q6W
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      7
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      25
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      14
      num At Risk
      36
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      17
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      10
      num At Risk
      36
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      13
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      9
      num At Risk
      36
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Leukopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      3
      num At Risk
      36
    term
    Pericardial effusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Atrial fibrillation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Periorbital oedema
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      36
    term
    Dry eye
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Visual impairment
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      5
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      22
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      16
      num At Risk
      36
    term
    Nausea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      9
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      18
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      6
      num At Risk
      36
    term
    Constipation
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      5
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Febrile neutropenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Anaemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Pericardial effusion
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Cardiac arrest
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Supraventricular tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Hypothyroidism
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Abdominal pain
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Gastrointestinal haemorrhage
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Nausea
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      36
    term
    Small intestinal obstruction
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      4
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      5
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      16
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      26
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      19
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      69
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      36
    term
    Abdominal compartment syndrome
time Frame
Day 1 to End of Study (a maximum of 18 months)

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Preserved source evidence · Not medical advice