Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00465985 · ADVERSE EVENTS

Adverse events

Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome · Source last updated 2017-08-28

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
48 weeks
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Part I ACZ885

ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.

0 / 3527 / 35Not reported / Not reported
Part II ACZ885

ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.

0 / 1515 / 15Not reported / Not reported
Part II Placebo

Placebo subcutaneous injection every 8 weeks.

0 / 1614 / 16Not reported / Not reported
Part III ACZ885

ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.

2 / 3124 / 31Not reported / Not reported
Entire Study ACZ885

Entire study ACZ885. The SAE and AEs were collected and reported for all three periods.

2 / 3535 / 35Not reported / Not reported

Group identifiers: EG000: Part I ACZ885 · EG001: Part II ACZ885 · EG002: Part II Placebo · EG003: Part III ACZ885 · EG004: Entire Study ACZ885

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Vertigo
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Blindness unilateral
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Post lumbar puncture syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Intraocular pressure increased

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Lymphocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Hypoacusis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      35
    term
    Tinnitus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      35
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Erythema of eyelid
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Eye pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Abdominal discomfort
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      35
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      35
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      35
    term
    Aphthous stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      35
    term
    Diarrhoea
Complete source fields
event Groups
  1. description
    ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
    id
    EG000
    other Num Affected
    27
    other Num At Risk
    35
    serious Num Affected
    0
    serious Num At Risk
    35
    title
    Part I ACZ885
  2. description
    ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
    id
    EG001
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    0
    serious Num At Risk
    15
    title
    Part II ACZ885
  3. description
    Placebo subcutaneous injection every 8 weeks.
    id
    EG002
    other Num Affected
    14
    other Num At Risk
    16
    serious Num Affected
    0
    serious Num At Risk
    16
    title
    Part II Placebo
  4. description
    ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
    id
    EG003
    other Num Affected
    24
    other Num At Risk
    31
    serious Num Affected
    2
    serious Num At Risk
    31
    title
    Part III ACZ885
  5. description
    Entire study ACZ885. The SAE and AEs were collected and reported for all three periods.
    id
    EG004
    other Num Affected
    35
    other Num At Risk
    35
    serious Num Affected
    2
    serious Num At Risk
    35
    title
    Entire Study ACZ885
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Lymphocytosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Hypoacusis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      35
    term
    Tinnitus
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      35
    term
    Vertigo
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Erythema of eyelid
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Eye pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Abdominal discomfort
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      35
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      35
    term
    Abdominal pain upper
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      35
    term
    Aphthous stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      35
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Vertigo
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Blindness unilateral
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Pyrexia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Sepsis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Post lumbar puncture syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      35
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      16
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      31
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      35
    term
    Intraocular pressure increased
time Frame
48 weeks

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice