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NCT02104427 · ADVERSE EVENTS

Adverse events

PD and Safety of TG-0054 Combined With G-CSF in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients · Source last updated 2021-04-19

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
10 µg/kg/Day G-CSF Alone

Days 1 through 4

0 / 122 / 120 / 12
10 µg/kg/Day G-CSF + 3.14 mg/kg TG-0054

Day 5 until end of study

0 / 126 / 120 / 12
Overall

Not reported

0 / 127 / 120 / 12

Group identifiers: EG000: 10 µg/kg/Day G-CSF Alone · EG001: 10 µg/kg/Day G-CSF + 3.14 mg/kg TG-0054 · EG002: Overall

Serious adverse events

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

    Other reported adverse events

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

    1. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        12
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Hypocalcaemia
    2. organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        12
        num Events
        0
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        12
        num Events
        2
      term
      Bone pain
    3. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Diarrhoea
    4. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Dry mouth
    5. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Nausea
    6. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Hypokalaemia
    7. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Oedema peripheral
    8. organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Platelet count decreased
    9. organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Paraesthesia
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      12
      description
      Days 1 through 4
      id
      EG000
      other Num Affected
      2
      other Num At Risk
      12
      serious Num Affected
      0
      serious Num At Risk
      12
      title
      10 µg/kg/Day G-CSF Alone
    2. deaths Num Affected
      0
      deaths Num At Risk
      12
      description
      Day 5 until end of study
      id
      EG001
      other Num Affected
      6
      other Num At Risk
      12
      serious Num Affected
      0
      serious Num At Risk
      12
      title
      10 µg/kg/Day G-CSF + 3.14 mg/kg TG-0054
    3. deaths Num Affected
      0
      deaths Num At Risk
      12
      id
      EG002
      other Num Affected
      7
      other Num At Risk
      12
      serious Num Affected
      0
      serious Num At Risk
      12
      title
      Overall
    frequency Threshold
    0
    other Events
    1. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        12
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Hypocalcaemia
    2. organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
        num Events
        2
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        12
        num Events
        0
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        12
        num Events
        2
      term
      Bone pain
    3. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Diarrhoea
    4. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Dry mouth
    5. organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Nausea
    6. organ System
      Metabolism and nutrition disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Hypokalaemia
    7. organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Oedema peripheral
    8. organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Platelet count decreased
    9. organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        12
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        12
        num Events
        1
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        12
        num Events
        1
      term
      Paraesthesia

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice