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NCT05091528 · ADVERSE EVENTS

Adverse events

A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers · Source last updated 2022-08-18

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
18 weeks
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
SBT6050 + T-DXd (6.4 mg/kg)

SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles

0 / 11 / 10 / 1
SBT6050 + Tucatinib + Trastuzumab

SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles

0 / 11 / 10 / 1

Group identifiers: EG000: SBT6050 + T-DXd (6.4 mg/kg) · EG001: SBT6050 + Tucatinib + Trastuzumab

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
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Fatigue
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Cytokine release syndrome
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        1
      term
      Injection site reaction
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Decreased appetite
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Palmar-plantar erythrodysesthesia
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Bloating
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        1
      term
      Constipation
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      1
      description
      SBT6050 plus trastuzumab deruxtecan SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles trastuzumab deruxtecan: 6.4 mg/kg by IV infusion in 21-day cycles
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      title
      SBT6050 + T-DXd (6.4 mg/kg)
    2. deaths Num Affected
      0
      deaths Num At Risk
      1
      description
      SBT6050 plus tucatinib and trastuzumab SBT6050: Dosed with 0.45 mg/kg by subcutaneous (SC) injection in 21-day cycles tucatinib: 300 mg by mouth (PO) twice daily (BID) trastuzumab: 8 mg/kg loading dose (first dose), then 6 mg/kg maintenance dose (subsequent doses) IV infusion in 21-day cycles
      id
      EG001
      other Num Affected
      1
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      title
      SBT6050 + Tucatinib + Trastuzumab
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Fatigue
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Cytokine release syndrome
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        1
      term
      Injection site reaction
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Decreased appetite
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Palmar-plantar erythrodysesthesia
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        1
      term
      Bloating
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      MedDRA (24.0)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        1
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        1
      term
      Constipation
    time Frame
    18 weeks

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

    Preserved source evidence · Not medical advice