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NCT00999830 · ADVERSE EVENTS

Adverse events

Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma · Source last updated 2016-03-24

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
Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: IPH2101 0.2mg/Kg

every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.

2 / 1414 / 14Not reported / Not reported
Arm B: IPH2101 2mg/kg

every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.

0 / 1311 / 13Not reported / Not reported

Group identifiers: EG000: Arm A: IPH2101 0.2mg/Kg · EG001: Arm B: IPH2101 2mg/kg

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    This serious adverse event was not related to the investigational Medicinal Product
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Disease progression

Other reported adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Abdominal pain upper
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Dry mouth
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      14
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
      num Events
      3
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
      num Events
      3
    term
    Chills
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Bronchitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Rhinitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Nasopharyngitis
Complete source fields
event Groups
  1. description
    every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
    id
    EG000
    other Num Affected
    14
    other Num At Risk
    14
    serious Num Affected
    2
    serious Num At Risk
    14
    title
    Arm A: IPH2101 0.2mg/Kg
  2. description
    every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
    id
    EG001
    other Num Affected
    11
    other Num At Risk
    13
    serious Num Affected
    0
    serious Num At Risk
    13
    title
    Arm B: IPH2101 2mg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Abdominal pain upper
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      14
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Dry mouth
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      14
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      14
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
      num Events
      3
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      13
      num Events
      3
    term
    Chills
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      14
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Bronchitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      13
      num Events
      2
    term
    Rhinitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
      num Events
      1
    term
    Nasopharyngitis
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    This serious adverse event was not related to the investigational Medicinal Product
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Bronchitis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      14
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
      num Events
      0
    term
    Disease progression
time Frame
Adverse events collected from screening visit (date of signature of Inform Consent Form) up to the End of Study

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Preserved source evidence · Not medical advice