Trial · NCT01414075
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 26 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Number of Participants Requiring Therapeutic Phlebotomy | Baseline up to Week 13 | Number of participants who required therapeutic phlebotomy due to TEAE of abnormal erythropoiesis is reported. |
| Secondary | Number of Participants Withdrawn From the Study Due to Inadequate Efficacy | Baseline up to Week 16 | Number of participants withdrawn from the study due to inadequate efficacy is reported. |
| Secondary | Change From Baseline in Short Form 36 (SF-36) Version 2 Physical Functioning Subscore and Vitality Subscore at Weeks 9 and 13 | Baseline, Weeks 9 and 13 | The SF-36 V2 consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The physical functioning subscore and vitality subscore are reported. The scores ranged from 0 (worst) to 100 (Best). Higher score indicated a better health state. Baseline is defined as the last non-missing value prior to the first dose administration. |
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Total Score at Weeks 9 and 13 | Baseline, Weeks 9 and 13 | FACT-An is composed of 27 core items which assess participant's function in 4 domains and 20 anemia-related items, grouped into 5 subscales as follows: Physical well-being (PWB): 7 items; Social/family well-being (SWB): 7 items; Emotional well-being (EWB): 6 items; Functional well-being (FWB): 7 items; and Anemia: 20 items. All FACT-An items were rated as: 0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much. Each subscale score was the sum of scores for the items in the subscale. The FACT-An total score was the sum of all 5 subscale scores, ranging from 0 (worst) - 188 (best). Higher scores represented better quality of life. Baseline is defined as the last non-missing value prior to the first dose administration. |
| Secondary | Number of Participants With Potentially Clinically Significant Laboratory Tests | Baseline up to Week 16 | Criteria for the potential clinical significance included: bilirubin (µmol/L) \>1.5 \* upper limit of normal (ULN), potassium (mmol/L) \>1.2 \* ULN, neutrophils (\*10\^9/L) ≤1, protein (g/L) \>1.1 \* ULN, leukocytes (\*10\^9/L) ≤2.5 or ≥15. |
| Secondary | Number of Participants With TEAEs | Baseline up to Week 16 | An adverse event (AE) was any untoward medical event in a participant who received study drug whether or not the event is considered drug related. TEAEs were defined as any event that either began or worsened after the first administration of study drug and within 28 days of the last dose. A summary of other nonserious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
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/NCT01414075/registered?page=2