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NCT02770014 · ADVERSE EVENTS

Adverse events

Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer · Source last updated 2019-11-22

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 collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.
Other-event reporting threshold
0%

CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
EGFR Exon 19 Positive Treatment With Erlotinib

Erlotinib will be initially dosed at a pre-determine dosage daily, and it will be given on a 6-week cycle with treatment administered on an outpatient basis

0 / 66 / 60 / 6

Group identifiers: EG000: EGFR Exon 19 Positive Treatment With Erlotinib

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
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Anemia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Paroxysmal atrial tachycardia
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Ear pain
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        3
      term
      Abdominal pain
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        4
      term
      Constipation
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        6
        num Events
        3
      term
      Diarrhea
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        2
      term
      Dry mouth
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Dyspepsia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Gastritis
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Gastrointestinal disorders - Other, specify
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        2
      term
      Nausea
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Vomiting
    Complete source fields
    description
    CTCAE version 4.03 was used for reporting adverse events. Serious Adverse Events were not collected/assessed for the Plasma Genotyping Participants, unless felt to be related to the study procedures. No such SAEs occurred on this study.
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      6
      description
      Erlotinib will be initially dosed at a pre-determine dosage daily, and it will be given on a 6-week cycle with treatment administered on an outpatient basis
      id
      EG000
      other Num Affected
      6
      other Num At Risk
      6
      serious Num Affected
      0
      serious Num At Risk
      6
      title
      EGFR Exon 19 Positive Treatment With Erlotinib
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Anemia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Paroxysmal atrial tachycardia
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Ear and labyrinth disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Ear pain
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        3
      term
      Abdominal pain
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        4
      term
      Constipation
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        6
        num Events
        3
      term
      Diarrhea
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        2
      term
      Dry mouth
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Dyspepsia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Gastritis
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Gastrointestinal disorders - Other, specify
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        6
        num Events
        2
      term
      Nausea
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        6
        num Events
        1
      term
      Vomiting
    time Frame
    Adverse events were collected for the 6 participants who received erlotinib treatment from time of initiation of erlotinib through end of study. This time frame was a maximum of 21 months from initiation of erlotinib treatment to study completion.

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    Preserved source evidence · Not medical advice