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NCT02092909 · ADVERSE EVENTS

Adverse events

Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia · Source last updated 2019-09-10

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
From obtaining informed consent through EOS visit. (up to 24 weeks)
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
IMO-8400 0.6 mg/kg 1x/wk

IMO-8400 0.6 mg/kg once weekly s.c.

0 / 66 / 60 / 6
IMO-8400 1.2 mg/kg 1x/wk

IMO-8400 1.2 mg/kg once weekly s.c.

0 / 55 / 50 / 5
IMO-8400 1.2 mg/kg 2x/wk

IMO-8400 1.2 mg/kg twice weekly s.c.

1 / 1413 / 140 / 14
IMO-8400 2.4 mg/kg 1x/wk

IMO-8400 2.4 mg/kg once weekly s.c.

2 / 66 / 60 / 6

Group identifiers: EG000: IMO-8400 0.6 mg/kg 1x/wk · EG001: IMO-8400 1.2 mg/kg 1x/wk · EG002: IMO-8400 1.2 mg/kg 2x/wk · EG003: IMO-8400 2.4 mg/kg 1x/wk

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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Arthritis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Lower limb fracture
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Pulmonary embolism
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Sepsis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Arthralgia

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 (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Lymph node pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Splenomegaly
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Tinnitus
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Diplopia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Dry eye
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Eye pruritis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Lacrimation increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Vision blurred
Complete source fields
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    IMO-8400 0.6 mg/kg once weekly s.c.
    id
    EG000
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    IMO-8400 0.6 mg/kg 1x/wk
  2. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    IMO-8400 1.2 mg/kg once weekly s.c.
    id
    EG001
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    0
    serious Num At Risk
    5
    title
    IMO-8400 1.2 mg/kg 1x/wk
  3. deaths Num Affected
    0
    deaths Num At Risk
    14
    description
    IMO-8400 1.2 mg/kg twice weekly s.c.
    id
    EG002
    other Num Affected
    13
    other Num At Risk
    14
    serious Num Affected
    1
    serious Num At Risk
    14
    title
    IMO-8400 1.2 mg/kg 2x/wk
  4. deaths Num Affected
    0
    deaths Num At Risk
    6
    description
    IMO-8400 2.4 mg/kg once weekly s.c.
    id
    EG003
    other Num Affected
    6
    other Num At Risk
    6
    serious Num Affected
    2
    serious Num At Risk
    6
    title
    IMO-8400 2.4 mg/kg 1x/wk
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Lymph node pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Splenomegaly
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Tachycardia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Tinnitus
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Diplopia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Dry eye
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Eye pruritis
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
    term
    Lacrimation increased
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
    term
    Vision blurred
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      14
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Arthritis
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Lower limb fracture
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Pulmonary embolism
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Sepsis
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (16.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      6
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      5
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      14
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      6
      num Events
      1
    term
    Arthralgia
time Frame
From obtaining informed consent through EOS visit. (up to 24 weeks)

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