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NCT01222286 · ADVERSE EVENTS

Adverse events

Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma · Source last updated 2026-05-14

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 related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
IPH2101 0.2 mg/kg

0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles

2 / 1612 / 16Not reported / Not reported
IPH2101 2 mg/kg

2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles

0 / 1412 / 14Not reported / Not reported

Group identifiers: EG000: IPH2101 0.2 mg/kg · EG001: IPH2101 2 mg/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 event was assessed as possibly related to study treatment
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    This event was assessed as unlikely related to study treatment
    organ System
    Nervous system disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Demyelinating polyneuropathy

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
    General disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      16
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      14
      num Events
      5
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      16
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Rash
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
      num Events
      3
    term
    Chills
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
      num Events
      3
    term
    Dizziness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      16
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
      num Events
      3
    term
    Pruritus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Edema Peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    muscle spasms
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Muscular weakness
Complete source fields
event Groups
  1. description
    0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
    id
    EG000
    other Num Affected
    12
    other Num At Risk
    16
    serious Num Affected
    2
    serious Num At Risk
    16
    title
    IPH2101 0.2 mg/kg
  2. description
    2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
    id
    EG001
    other Num Affected
    12
    other Num At Risk
    14
    serious Num Affected
    0
    serious Num At Risk
    14
    title
    IPH2101 2 mg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      16
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      14
      num Events
      5
    term
    Fatigue
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      16
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Rash
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
      num Events
      3
    term
    Chills
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
      num Events
      3
    term
    Dizziness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      16
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Pyrexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      14
      num Events
      3
    term
    Pruritus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Nausea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    Edema Peripheral
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      14
      num Events
      2
    term
    back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    muscle spasms
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      14
      num Events
      1
    term
    Muscular weakness
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    This event was assessed as possibly related to study treatment
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    This event was assessed as unlikely related to study treatment
    organ System
    Nervous system disorders
    source Vocabulary
    MedDra 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      14
      num Events
      0
    term
    Demyelinating polyneuropathy
time Frame
Adverse events related to Study Drug, collected from screening visit (date of signature of Inform Consent Form) up to the End of Study, up to 14 months

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Preserved source evidence · Not medical advice