Trial · NCT05954780
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 42
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline of EORTC global health scale | Baseline, up to 40 months | Change from baseline quality of life (QoL) over time for the global health scale of the EORTC QLQ- C30 questionnaire. |
| Secondary | Change from baseline of EORTC QLQ-C30 further scales | Baseline, up to 40 months | Change from baseline in further scales of the EORTC QLQ-C30 questionnaire |
| Secondary | Change from baseline of EORTC QLQ-MY20 further scales | Baseline, up to 30 days after selinexor treatment | Change from baseline in further scales of the EORTC QLQ-MY20 questionnaire |
| Secondary | Assessment of drug tolerability and safety | Baseline, up to 40 months | Frequency of specific (serious) adverse drug reactions ((S)ADRs) (nausea, weight loss, diarrhea, vomiting, fatigue) |
| Secondary | Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE | Baseline, up to 30 days after end of selinexor treatment | Incidence of (serious) AEs ((S)AEs) as characterized by type, frequency, severity and seriousness. |
| Secondary | Adverse drug reaction (ADR) and serious adverse drug reactions (SADR) | Baseline, up to 30 days after end of selinexor treatment | Incidence of (serious) adverse drug reactions ((S)ADRs) as characterized by type, frequency, severity and seriousness. |
| Secondary | Adverse events of special interest (AESI) | Baseline, up to 30 days after end of selinexor treatment | Incidence of AEs of special interest defined as cataracts (new-onset cataracts and worsening of cataracts) and Acute cerebellar syndrome. |
| Secondary | Changes in selinexor therapy | From date of selinexor treatment start, up to 40 months | Frequency of treatment delays, no administrations (skips), discontinuation (withdrawn) of selinexor due to safety reasons |
| Secondary | Effectiveness in routine treatment: Best response | Baseline, up to 40 months | Frequencies of best response during selinexor therapy will be calculated using descriptive statistics. |
| Secondary | Effectiveness in routine treatment: Overall response rate (ORR) | Baseline, up to 40 months | ORR of patients will be calculated. ORR is defined as the proportion of patients achieving a complete response, very good partial response or partial response as best overall response. Patients without response measurement are considered non-responders. |
| Secondary | Effectiveness in routine treatment: Disease control rate (DCR) | Baseline, up to 40 months | DCR is defined as the proportion of patients achieving complete response, very good partial response, partial response, or stable disease as best response. Patients without response measurement are considered non-responders. |
| Secondary | Effectiveness in routine treatment: Progression-free survival (PFS) | Baseline, up to 40 months | PFS is defined as the time interval measured from the day of first selinexor administration to first progression or death, whichever comes first. |
| Secondary | 6 months PFS rate | Baseline, until 6 months after start of selinexor treatment | PFS rates will be analysed 6 months after treatment start of selinexor |
| Secondary | 12 months PFS rate | Baseline, until 12 months after start of selinexor treatment | PFS rates will be analysed 12 months after treatment start of selinexor |
| Secondary | Effectiveness in routine treatment: Overall survival (OS) | Baseline, up to 40 months | OS is defined as the time interval measured from the day of first selinexor administration to time of death from any cause. |
| Secondary | 6 months OS rate | Baseline, until 6 months after start of selinexor treatment | OS rates will be analysed 6 and 12 months after treatment start of selinexor |
| Secondary | 12 months OS rate | Baseline, until 12 months after start of selinexor treatment | OS rates will be analysed 6 and 12 months after treatment start of selinexor |
| Secondary | Selinexor therapy: Dosing | Baseline, up to end of selinexor treatment | Dose intensity during treatment (mg/m2 per week) will be analysed |
| Secondary | Selinexor therapy: Frequency | Cycle 1, day 1 | Frequency of starting dose of selinexor (100 mg, 80 mg, 60 mg, other) will be analysed |
| Secondary | Selinexor therapy: Dose reduction of starting dose | Cycle 1, day 1 | Reasons for reduced starting dose compared to SmPC will be analysed |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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