Trial · NCT05014139
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events (AEs) | Approximately 1 year | An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. |
| Primary | Incidence of laboratory abnormalities | Approximately 1 year | To be summarized using descriptive statistics. |
| Primary | Incidence of dose limiting toxicities (DLTs) | Approximately 7 weeks | To be summarized using descriptive statistics. |
| Secondary | Pharmacokinetics (PK) of enfortumab vedotin: Area under the concentration-time curve (AUC) | Approximately 1 year | AUC will be recorded from the PK blood samples collected. |
| Secondary | PK of enfortumab vedotin: Maximum concentration (Cmax) | Approximately 1 year | Cmax will be recorded from the PK blood samples collected. |
| Secondary | PK of enfortumab vedotin: Time to maximum concentration concentration (tmax) | Approximately 1 year | Tmax will be recorded from the PK blood samples collected. |
| Secondary | PK of enfortumab vedotin: Apparent terminal half-life (t1/2) | Approximately 1 year | T1/2 will be recorded from the PK blood samples collected. |
| Secondary | PK of enfortumab vedotin: Trough concentration (Ctrough) | Approximately 1 year | Ctrough will be recorded from the PK blood samples collected. |
| Secondary | Incidence of antitherapeutic antibodies (ATAs) to enfortumab vedotin | Approximately 1 year | Blood samples for ATA analysis will be collected. |
| Secondary | Complete response (CR) rate | Up to 24 months | CR rate is defined as the proportion of subjects achieving CR. |
| Secondary | Duration of CR | Up to 3.5 years | The time from first documented CR to the first evidence of recurrence, progression, or death due to any cause. |
| Secondary | Rate of cystectomy | Up to 3.5 years | The proportion of subjects who subsequently undergo cystectomy. |
| Secondary | Progression-free survival | Up to 3.5 years | The time from start of study treatment to the first evidence of progression or death due to any cause. |
| Secondary | Cystectomy-free survival | Up to 3.5 years | The time from start of study treatment to cystectomy or death due to any cause. |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05014139/registered