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NCT05346237 · ADVERSE EVENTS

Adverse events

Validation and Cross-cultural Adaptation of Croatian SECEL Questionnaire · Source last updated 2025-05-06

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
15 minutes
Other-event reporting threshold
0%

The SECEL is a 35-item patient-reported questionnaire developed to address the communication needs of patients with laryngectomies. The aim was to translate, cross-culturally adapt and validate Croatian version. The SECEL:HR was filled in by 50 laryngectomised patients.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Adult Laryngectomised Patients

Patients who have undergone total laryngectomy and completed minimal their 12-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy Quality of life questionnaire: Filling out questionnaires, measuring maximum phonation and diadochokinesis

0 / 500 / 500 / 50

Group identifiers: EG000: Adult Laryngectomised 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.

      Complete source fields
      description
      The SECEL is a 35-item patient-reported questionnaire developed to address the communication needs of patients with laryngectomies. The aim was to translate, cross-culturally adapt and validate Croatian version. The SECEL:HR was filled in by 50 laryngectomised patients.
      event Groups
      1. deaths Num Affected
        0
        deaths Num At Risk
        50
        description
        Patients who have undergone total laryngectomy and completed minimal their 12-month period without disease after surgery and post-operative treatments such as radiotherapy or chemotherapy Quality of life questionnaire: Filling out questionnaires, measuring maximum phonation and diadochokinesis
        id
        EG000
        other Num Affected
        0
        other Num At Risk
        50
        serious Num Affected
        0
        serious Num At Risk
        50
        title
        Adult Laryngectomised Patients
      frequency Threshold
      0
      time Frame
      15 minutes

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

      Preserved source evidence · Not medical advice