Trial · NCT01367665
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experienced Any Adverse Events (AEs), AEs Grade 3 or 4, AEs Leading to Drug Interruptions or Discontinuations and Any Serious Adverse Events (SAEs) | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | percentage of participants | NUMBER | |
| PRIMARY | Percentage of Participants Who Died Due to Adverse Events, Disease Progression or Other Reasons | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | percentage of participants | NUMBER | |
| PRIMARY | Percentage of Participants Who Report a Shift in NCI CTCAE Grades to 3/4 in Hematology and Biochemistry Laboratory Parameters | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | percentage of participants | NUMBER | |
| PRIMARY | Exposure to Study Treatment: Duration on Treatment | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | days | MEDIAN | |
| PRIMARY | Exposure to Study Treatment - Dose Intensity | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | percentage of doses | MEDIAN | |
| SECONDARY | Best Overall Response Rate (BORR) | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | Only included participants that had histologically confirmed measurable disease at baseline. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | Only included participants that had histologically confirmed disease, measureable disease status at baseline (measureable or non-measureable) and reported a response of CR or PR. | months | MEDIAN |
| SECONDARY | Time to Response | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | Only included participants that had histologically confirmed measurable disease at baseline. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | Only included participants that had histologically confirmed disease and measureable disease status at baseline (measureable or non-measureable). | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline to the data cut-off of 14 June 2017 (up to 6 years) | Only included participants that had histologically confirmed disease and measureable disease status at baseline (measureable or non-measureable). | months | MEDIAN |
| SECONDARY | Change From Baseline Scores of Skindex-16 Questionnaire Domains of Emotion, Function and Symptom | Baseline to the data cut-off date of 14 June 2017 (up to 6 years). | Only included participants that had histologically confirmed disease at baseline. For each time point, Number Analyzed refers to patients with non-missing values. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With a ≥ 30% Reduction in Disease-Related Symptoms According to MDASI Scale | 08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month). | Included only participants who were enrolled after Protocol Version 4 was implemented, had non-missing data and baseline score ≥4. Per protocol, the MDASI measurements were measured in Metastatic patients only. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a ≥ 30% Reduction in Composite Symptom Severity Score According to MDASI Scale | 08-May-2013 (Protocol Version ≥ 4) to the data cut-off date of 14 June 2017 (approximately 4 years and 1 month). | Included only participants who were enrolled after Protocol Version 4 was implemented, had non-missing data and average baseline score ≥ 4. Per protocol, the MDASI measurements were measured in Metastatic patients only. | Percentage of participants | NUMBER |
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.
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GET https://conductscience.org/api/trials/v1/NCT01367665/outcomes