Trial · NCT01906489
Registered outcomes47
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 40 of 47
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs) | Up to 20 Weeks | An Adverse Event (AE) was defined as any untoward medical occurrence, signs, symptoms, disease, or laboratory or physiological observations occurring in a participant administered with drug, regardless of a causal relationship with that treatment or usage. This also included all suspected adverse medication reactions, reactions from medication overdose, abuse, withdrawal, sensitivity, toxicity, unrelated illnesses, including worsening a pre-existing condition, injury, or accidents. Serious Adverse Events (SAEs) was defined as any life-threatening condition; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or death. |
| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values | Up to 20 Weeks | Parameters assessed for laboratory values included hematology, serum chemistry, and urinalysis. The investigator was responsible for reviewing laboratory results for clinically significant changes. |
| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | Up to 20 Weeks | Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing laboratory results for clinically significant changes. |
| Secondary | Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings | Up to 20 Weeks | A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The investigator was responsible for reviewing laboratory results for clinical significance. |
| Secondary | Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Findings | Up to 20 Weeks | A Baseline physical examination was performed at screening. Otherwise, abbreviated physical examinations were conducted and were to include heart, lung, and abdomen. The investigator was responsible for reviewing laboratory results for clinically significant changes. |
| Other | Exploratory: Change From Baseline in Iron and Total Iron Binding Capacity (TIBC) | Baseline and up to Week 20 | |
| Other | Exploratory: Change From Baseline in Transferrin | Baseline and up to Week 20 | |
| Other | Exploratory: Change From Baseline in Transferrin Saturation | Baseline and up to Week 20 | |
| Other | Exploratory: Mean Weekly Dose of Intravenous Elemental Iron Administered | Baseline and up to Week 20 | |
| Other | Exploratory: Absolute Values of Iron and Total Iron Binding Capacity (TIBC) | Baseline and up to Week 20 | |
| Other | Exploratory: Absolute Values of Transferrin | Baseline and up to Week 20 | |
| Other | Exploratory: Absolute Values of Transferrin Saturation | Baseline and up to Week 20 | |
| Other | Exploratory: Absolute Values of Reticulocyte Hemoglobin Content | Baseline and up to Week 20 | |
| Other | Exploratory: Change From Baseline in Reticulocyte Hemoglobin Content | Baseline and up to Week 20 | |
| Other | Exploratory: Change From Baseline in Hemoglobin A1c | Baseline and up to Week 20 | |
| Other | Exploratory: Absolute Values of Hemoglobin A1c | Baseline and up to Week 20 | |
| Other | Exploratory: Absolute Values of Lipids | Baseline and up to Week 20 | |
| Other | Exploratory: Change From Baseline in Lipids | Baseline and up to Week 20 | |
| Other | Exploratory: Change From Baseline in Hepcidin | Baseline and up to Week 20 | |
| Other | Exploratory: Absolute Values of Hepcidin | Baseline and up to Week 20 |
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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