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NCT02440685 · ADVERSE EVENTS

Adverse events

A Phase 1/2 Study To Evaluate ASN002 In Relapsed/Refractory Lymphoma And Advanced Solid Tumors · Source last updated 2023-06-07

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
Days of duration ranged from 4 days to 280 days before early termination of the study
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
10 mg BID

ASN002 10 mg BID

1 / 33 / 30 / 3
20 mg BID

ASN002 20 mg BID

2 / 44 / 41 / 4
30 mg BID

ASN002 30 mg BID

0 / 32 / 30 / 3
40 mg BID

ASN002 40 mg BID

2 / 44 / 41 / 4
50 mg BID

ASN002 50 mg BID

5 / 76 / 72 / 7
75 mg BID

ASN002 75 mg BID

10 / 1514 / 156 / 15
100 mg BID

ASN002 100 mg BID

4 / 55 / 52 / 5
80 mg QD

ASN002 80 mg QD

4 / 77 / 70 / 7
120 mg QD

ASN002 120 mg QD

1 / 33 / 30 / 3

Group identifiers: EG000: 10 mg BID · EG001: 20 mg BID · EG002: 30 mg BID · EG003: 40 mg BID · EG004: 50 mg BID · EG005: 75 mg BID · EG006: 100 mg BID · EG007: 80 mg QD · EG008: 120 mg QD

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
    General disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Disease progression
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Renal failure acute
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Malignant neoplasm progression
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Pneumonia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Small intestinal obstruction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Anaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Abdominal pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Acute respiratory distress syndrome
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Bacteraemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Cellulitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Chest pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Device related infection

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 (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Chills
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Disease progression
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Pyrexia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Pneumonia
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    ASN002 10 mg BID
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    10 mg BID
  2. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    ASN002 20 mg BID
    id
    EG001
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    20 mg BID
  3. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    ASN002 30 mg BID
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    30 mg BID
  4. deaths Num Affected
    1
    deaths Num At Risk
    4
    description
    ASN002 40 mg BID
    id
    EG003
    other Num Affected
    4
    other Num At Risk
    4
    serious Num Affected
    2
    serious Num At Risk
    4
    title
    40 mg BID
  5. deaths Num Affected
    2
    deaths Num At Risk
    7
    description
    ASN002 50 mg BID
    id
    EG004
    other Num Affected
    6
    other Num At Risk
    7
    serious Num Affected
    5
    serious Num At Risk
    7
    title
    50 mg BID
  6. deaths Num Affected
    6
    deaths Num At Risk
    15
    description
    ASN002 75 mg BID
    id
    EG005
    other Num Affected
    14
    other Num At Risk
    15
    serious Num Affected
    10
    serious Num At Risk
    15
    title
    75 mg BID
  7. deaths Num Affected
    2
    deaths Num At Risk
    5
    description
    ASN002 100 mg BID
    id
    EG006
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    4
    serious Num At Risk
    5
    title
    100 mg BID
  8. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    ASN002 80 mg QD
    id
    EG007
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    4
    serious Num At Risk
    7
    title
    80 mg QD
  9. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    ASN002 120 mg QD
    id
    EG008
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    120 mg QD
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      3
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      5
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Thrombocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Chills
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Disease progression
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      3
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Pyrexia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Pneumonia
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Disease progression
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Renal failure acute
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Malignant neoplasm progression
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Pneumonia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Small intestinal obstruction
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Anaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Abdominal pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      3
    term
    Acute respiratory distress syndrome
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Bacteraemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Cellulitis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Chest pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (17.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      4
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      15
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      5
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      7
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      3
    term
    Device related infection
time Frame
Days of duration ranged from 4 days to 280 days before early termination of the study

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Preserved source evidence · Not medical advice