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NCT01458288 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease · 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
9 months, from 23-Oct-2012 to 09-Jul-2013
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)

TG-0054 (3.14 mg/kg) TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)

0 / 1210 / 12Not reported / Not reported

Group identifiers: EG000: TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)

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. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        12
      term
      Diarrhoea
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Abdominal pain
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Nausea
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Paraesthesia oral
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Blood pressure increased
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Haemoglobin decreased
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Platelet count decreased
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        12
      term
      Neuropathy peripheral
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Paraesthesia
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Cough
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
      term
      Dyspnoea
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
      term
      Nasal congestion
    Complete source fields
    event Groups
    1. description
      TG-0054 (3.14 mg/kg) TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)
      id
      EG000
      other Num Affected
      10
      other Num At Risk
      12
      serious Num Affected
      0
      serious Num At Risk
      12
      title
      TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        12
      term
      Diarrhoea
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Abdominal pain
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Nausea
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Paraesthesia oral
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Blood pressure increased
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Haemoglobin decreased
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Platelet count decreased
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        12
      term
      Neuropathy peripheral
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Paraesthesia
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        12
      term
      Cough
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
      term
      Dyspnoea
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        12
      term
      Nasal congestion
    time Frame
    9 months, from 23-Oct-2012 to 09-Jul-2013

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

    Preserved source evidence · Not medical advice