TriangleNCT05740566 · OUTCOME
Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)
This outcome was registered, but no numerical results were posted in the captured record.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to approximately 4 years
What was measured
PRO-CTCAE was a 78-item library used to measure patient-reported symptomatic adverse events. Users selected items that were most relevant to the disease, treatment profile, and fit for purpose to document patients' experience. Each symptom was rated by up to 3 attributes: presence/frequency, severity, and/or interference of the adverse event. Based on the safety profile of tarlatamab and SOC therapy, the study included the following symptoms: shivering or shaking chills, anxiety, constipation, taste changes, vomiting, headache, concentration, rash, palpitations, arm or leg swelling, nausea, dizziness, bruising, fatigue, and decreased appetite, which were deemed relevant for the site of cancer as well as cancer treatment. Responses were typically scored on a 5-point ordinal scale, with values ranging from 0 to 4. Higher scores indicated greater symptom burden.
Groups in this outcome
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- anticipated Posting Date
- 2028-03
- denom Units Selected
- Participants
- description
- PRO-CTCAE was a 78-item library used to measure patient-reported symptomatic adverse events. Users selected items that were most relevant to the disease, treatment profile, and fit for purpose to document patients' experience. Each symptom was rated by up to 3 attributes: presence/frequency, severity, and/or interference of the adverse event. Based on the safety profile of tarlatamab and SOC therapy, the study included the following symptoms: shivering or shaking chills, anxiety, constipation, taste changes, vomiting, headache, concentration, rash, palpitations, arm or leg swelling, nausea, dizziness, bruising, fatigue, and decreased appetite, which were deemed relevant for the site of cancer as well as cancer treatment. Responses were typically scored on a 5-point ordinal scale, with values ranging from 0 to 4. Higher scores indicated greater symptom burden.
- reporting Status
- NOT_POSTED
- time Frame
- Up to approximately 4 years
- title
- Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice