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NCT03930771 · ADVERSE EVENTS

Adverse events

Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas · Source last updated 2022-08-09

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 were monitored from the time of consent through six months after completion of the study.
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Patients

All subjects will receive: 1. Capecitabine (oral 5-Fluorouracil) 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. 2. Temozolomide (second generation alkylating agent) 150 to 200 mg/m2 orally on days 10 through 14. After completion of 6 cycles, patients achieving a complete or partial tumor response may continue to receive capecitabine temozolomide at the investigator's discretion in the absence of disease progression or unacceptable toxicity. Patients will be monitored for six months after they come off the study (either after completing 6 cycles or in setting of disease progression or unacceptable toxicity). Capecitabine: 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. Temozolomide: 150 to 200 mg/m2 orally on days 10 through 14.

0 / 11 / 10 / 1

Group identifiers: EG000: All Patients

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
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      term
      Fatigue
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      term
      Paresthesia
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      term
      Back pain
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      term
      Thrombocytopenia
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      1
      description
      All subjects will receive: 1. Capecitabine (oral 5-Fluorouracil) 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. 2. Temozolomide (second generation alkylating agent) 150 to 200 mg/m2 orally on days 10 through 14. After completion of 6 cycles, patients achieving a complete or partial tumor response may continue to receive capecitabine temozolomide at the investigator's discretion in the absence of disease progression or unacceptable toxicity. Patients will be monitored for six months after they come off the study (either after completing 6 cycles or in setting of disease progression or unacceptable toxicity). Capecitabine: 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. Temozolomide: 150 to 200 mg/m2 orally on days 10 through 14.
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      1
      serious Num Affected
      0
      serious Num At Risk
      1
      title
      All Patients
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      term
      Fatigue
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      term
      Paresthesia
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      term
      Back pain
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        1
      term
      Thrombocytopenia
    time Frame
    Adverse events were monitored from the time of consent through six months after completion of the study.

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

    Preserved source evidence · Not medical advice