Erythropoietin

Quality of life assessment: Kidney Disease Quality of Life Questionnaire

Haemoglobin outcomes, including haemoglobin levels in g/dL, change in haemoglobin levels over time (in g/dL and %), number and proportion of patients with haematopoietic response, number and proportion of patients reaching target haemoglobin levels.

The assessment of effectiveness based on: epoetin alfa treatment schedule (dose and timing), hemoglobin effect, response to treatment (independent of blood transfusion), mean time to response, # of blood transfusions given, and iron supplementation

Use of allogenic blood transfusions

Percentage of Participants With an Increase From Baseline in Hemoglobin Level of Greater Than or Equal to (>/=) 1 g/dL or a Hemoglobin Level Between 10 and 12 g/dL After 9 Months of Treatment Without any Transfusional Recourse

Perioperative allogeneic red blood cell transfusion volume

Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline

Percentage of Participants With a Hemoglobin Value of 11-12 Grams Per Deciliter (g/dL) From Visit 7 (Month 7) to Visit 9 (Month 9)

Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)

Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose

The utility scores of hemodialysis (HD) patients who use EPO to maintain the Hb target level.

Transfusion

Haemoglobin level on postoperative day 5

Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route

Change in Interleukin 6(IL6)

Hb level change

endothelial function and atherosclerosis

Hemoglobin Levels

postoperative <12 month Angiogenesis

effect of erythropoietin on MDS prognosis

Mean change in haemoglobin levels

EPO concentration UI/L

Changes in serum protein isoforms measured by proteomics

Evaluate the percentage of patients achieving a target hemoglobin of 11 g/dL or greater by day 100 following allogeneic stem cell transplantation.

Haemoglobin Concentration

Treatment failure (changes in hemoglobin levels)

Changes in CD71 expression

The percentage of difference between radioactivity (quantified as counts per pixel) of the predefined area of interest of the experimental and control thenar muscle at one and four hours after reperfusion.

Cognitive function

Number of Subjects That Maintained Target Hemoglobin Level (11-12 g/dL) Maintenance Weekly for 12 Weeks

Exercise tolerance, measured as peak VO(subscript)2

Number of allogeneic red blood cell (RBC) transfusions.

Mean hemoglobin during the evaluation period.

The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)

Mean Hemoglobin (Hb) change from baseline to average levels from Week 28 to Week 52.

Number of patients who receive an allogenic red blood cell transfusion during the study, during each chemotherapy cycle, and at 4 weeks after the last administration of chemotherapy

Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period

The functional capacity measured by postoperative fatigue, work capacity, balance, and quality of life

Hemoglobin Incrementation

Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period

Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)

Lake Louise Score

Percentage of Participants Who Achieved a Clinical Response 3-4 Weeks After Start of Treatment

Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP)

Rate of patients with RNA-HCV negative in each arm at week 24 after the end of treatment.

Number of participants with Hematological evaluation

Hb level, decline in renal function, 24h proteinuria, creatinine clearance.

Decrease in Delayed Graft Function

Incidence of delirium

Percentage of patients with undetectable RNA-HCV

In-stent Neointimal volume

Incidence of Acute Kidney Injury Based on RIFLE Criteria

Pain visual analogue scale (P-VAS)

The impacts of different drug therapies (roxadustat or erythropoietin) on the sarcopenia status of patients

Hb level, BP.

Cost of Erythropoiesis Stimulating Agent

Local pain due to s.c. injection (by VAS).

A secure web-based assessment of cancer-related symptoms (LCSS), functional status (SF-36), and quality of life (FACT-An and PFS) will be obtained every 2 weeks (weeks 3, 5, 7, 9, 11, and 13).

Acute mountain sickness score

Number of Participants Receiving pRBC (Packed Red Blood Cell) Transfusions

Number of subjects with adverse events and percentage of therapy withdrawals due to treatment emergent adverse events

Increase in Hb >1.0g/dL from baseline, and Hb conc. >11g/dL without red blood cell transfusion, for dialysis patients;Hb conc >11-12 g/dL for pre-dialysis patients

Incidence of adverse events

Frequency and percentage of subjects in each dosing regimen will be summarized. Hemoglobin (Hb) response and maintenance of initial treatment phase Hb with alternate doses of Epoetin alfa. Time and reasons for discontinuing Epoetin alfa.

Difference From Baseline to Day 15 in Area Under Curve (AUC) of GI Iron Absorption (0-3 Hours)

Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study

3.2 km self-paced treadmill time trial performance

Dimensional changes

Change in physical function score as measured by the Six Minute Walk Test (6MWT) and Short Physical Performance (SPP) Summary Score compared from Baseline to Week 5, Week 9, Week 13, Week 17/ Early Withdrawal and Week 20/Follow-up.

Reticulocyte count on day 7

The number of patients who receive RBC transfusion perioperatively

Change in Carotid Total Plaque Volume From Baseline to Approximately 1 Year, as Assessed by Non-contrast MRI

Change in Hb concentration between baseline and efficacy evaluation period (EEP).

change in hemoglobin

Hemoglobin values

Subject preference

Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis)

Overall Survival (OS)

Mean Change From Baseline in Hb Averaged Over Week 28 to Week 52

To investigate the Hb levels at each every 3 months follow up visit and the incidence of lack anticipated Hb response or loss of response to Biogeneric Epoetin. To monitor the occurrence of PRCA and other immunogenicity related adverse event.

Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)

Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation

Subject incidence of adverse events

Mean Change in Hemoglobin Between Baseline and the Evaluation Period

Percentage of Participants With Sustained Virologic Response (SVR)

TSAT (transferrin saturation), serum albumin, serum ferritin, serum transferrin, serum C reactive protein

Bayley III Composite Cognitive Score

Combined proportion of unfavourable neurological outcomes at 6 months: severe disability (defined as GOSE scores 2-4) or death (GOSE score 1).

Median Time to First Cardiovascular Event

Percent change in left ventricular volume index (LVVI) at Week 96.

Number of patients reaching a CPC (cerebral performance category) level 1 in each group

Mean Change in Hemoglobin Between Baseline and the Evaluation Period

Composite renal outcome of chronic dialysis, kidney transplantation, eGFR 6 mL/min/1.73m2 or less, or eGFR less than 50% of initial value.

Change in Hb level between the screening/baseline period and the evaluation period

Mean Absolute Change in Hemoglobin Levels Between the Screening/Baseline Period (Week -4 to Day 1) and the Evaluation Period (Week 21-28)

Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment

Ratio of weekly dose at the evaluation period to the weekly dose at baseline

Anti-Erythropoietin (EPO) Antibodies

Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks

Mean Change From Baseline in Hemoglobin Levels Over the Evaluation Period (Week 28 to Week 52)

Number of participants with lower-risk non-transfusion dependent myelodysplastic syndromes (NTD-MDS) who converted to Transfusion Dependence (TD) during any continuous 16-week interval within the 96-week treatment period

Hemoglobin level

Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)

Quality of Life - To compare the Quality of Life of low risk Myelodysplastic Syndrome (MDS) patients randomised to receive prolonged treatment with DA alone, DA with G-CSF or best supportive care alone

Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)

Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants

Change in Hemoglobin Level

Percentage of Participants with a Red Blood Cell Transfusion During Weeks 5 to 12

Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period

Change From Baseline in Hb to the Average Over the Primary Evaluation Period (PEP) (Weeks 20 to 26)

Proportion of patients in each treatment group, overall, and within each baseline hemoglobin group requiring blood transfusion following major orthopedic surgery

Mean Hb change

Mean Change From Baseline in Hemoglobin (Hgb) During Evaluation Period (Week 28 to Week 52)

Mean Hb Level of Week 20 and Week 24

Change from baseline in the average hemoglobin (Hb)

Fatigue response as measured by the Functional Assessment of Chronic Illness Therapy Fatigue Subscale

Hb response rate

Changed amount of mean hemoglobin level in evaluation period compared to the baseline

Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period

Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.

Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21).

Proportion of patients without transfusion after first month.

The primary end-point of this study is the development of AKI in placebo group compared with EPO group.

Rate of patients who maintain mean Hb concentration in the range of ≥ 10.0g/dL and ≤ 12.0g/dL

study of comparison between standard theraphy rEPO (40.000unit/week) and association therapy between rEPO (40.000unit/week)plus Acid 13-Cis-Retinoic and Dihydroxyvitamin D3

Hemoglobin response rate

Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1

Change From Baseline in Left Ventricle Mass Index (LVMI) at Month 15

The proportion of the subjects who receive red blood cell (RBC) transfusion and/or hemoglobin (Hb) concentration < 8.0 g/dL

Change in Hemoglobin (Hb) Level From Baseline to the Level Averaged Over Weeks 9-13

The proportion of subjects on QM darbepoetin alfa dosing maintained with a mean Hb greater than or equal to 11.0 g/dL during the evaluation phase

Percentage of Participants With at Least One Red Blood Cell (RBC) Transfusion During the Double-blind Treatment Period

Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)

Left ventricular ejection fraction measured by magnetic resonance imaging

Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period

Percentage of Participants Who Maintained Their Mean Hemoglobin Concentration Within +/- 1.0 Gram/Deciliter of Their Reference Hemoglobin Concentration and Between 10.0 and 12.0 Gram/Deciliter During the Efficacy Evaluation Period

Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)

The increase in Hb concentration

Mean Change From Baseline to the Highest Hemoglobin up to Day 71

Survival without neurologic sequelae

Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL

Percentage of Patients Able to Maintain Hemoglobin (Hb) Within 10-12 g/dL

The proportion of subjects on QM darbepoetin alfa dosing maintained with a mean Hb greater than or equal to 11.0 g/dL and less than or equal to 13.0 g/dL during the evaluation phase

Global retinal nerve fibre layer thickness (RNFLT-G)

Mean Hemoglobin (Hgb) During the Efficacy Evaluation Period

Proportion of patients starting three times per week vadadustat (TIW-V) who remain on TIW-V at week 20

Difference in mean hemoglobin (Hb) level between arms during the evaluation period after treatment (non-inferiority margin: -10 g/L)

The treatment response

Change of hemoglobin levels at correction phase (baseline vs end of treatment)

Percentage of Participants Who Achieved Hemoglobin Response up to Week 24

- Hemoglobin concentration

Number of units of blood self-donated; Number of donor-donated units of blood used; Total red blood cell volume; Total red blood cell production; Change in hemoglobin from baseline to after the final dose of study medication, but before surgery

The treatment response

Hemoglobin Level in blood

Percentage of Participants With Response to Treatment

Number of red blood cell transfusions

transplant free survival at 1 year

Short Form 36 Health Survey Questionnaire (SF-36) Vitality Subscale Score at Week 24

Percent of patients that achieved a hematopoietic response, defined as a Hb increase >= 2 g/dL and/or Hb = 12 g/dL during the study independent of transfusion within 28 days

Median Number of Participant Transfusions Required During 12 Weeks of Treatment

Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)

Red Blood Cell (RBC) Transfusion

Best Corrected Visual Acuity

Clinical Scoring

Number of units of units of blood donated by the patient; Number of units of donor blood transfused during surgery; Total red cell volume and percentage in self-donated blood; Percentage of sub-standard units of blood self-donated

Improvement of ASIA Impairment Scale of at least 1 grade. Score on ASIA Scale and a ASIA Impairment Scale are an inclusion criteria, then at 3rd, 7th, 14th, 30th, 60th, 90th days

Number of Participants With Treatment-emergent Adverse Events

Reduced incidence of transfusions

Neurological/functional outcome as measured by the Barthel Index (BI)

Quality of life (Functional Assessment of Cancer Therapy-Anemia [FACT-An] and EuroQOL-5D [EQ-5D])

Erythrocyte transfusions in infants 401-1,000g birthweight

The haematopoietic response at week 4, 8, 12, 16 and 20

change of left ventricular ejection fraction measured by cardiac MRI

Death or moderate or severe disability at 18-22 months of age

Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)

The size of the conjunctival epithelial defect

best corrected visual acuity

Change from Baseline Visual Capacity

Overall survival

Timing of treatment Substudy or Tier Advancement Pathway (TAP) assignment

Incidence of NEC

Change in hemoglobin (Hb) in chemotherapy induced anemia

Left ventricular ejection fraction 6 weeks after primary PCI, measured with planar radionuclide ventriculography

Mental developmental index (Bayley II) and motor, visual and hearing impairment

Exercise tolerance

Proportion of subjects whose baseline score on the subjective FCST correctly estimates the baseline MHST score

Number of Participants Hospitalized During the Test Period

Change in hemoglobin (Hb) from baseline to the end of the study; Primarily interested in the change in Hb between Q2W vs Q4W groups. Protocol Addendum: Hb change from baseline to end of open-label extension (no more than 36 weeks)

Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose

Hemoglobin (Hb) Change From Baseline to Study Week 7

Change From Baseline in Hemoglobin (Hgb) at Week 4

The proportion of subjects achieving an erythroid response during the 13-week test period

Incidence of adverse events

Change in local laboratory hemoglobin level from baseline

Toxicity

Average Hb change from baseline

Rate of rise of hemoglobin concentration

Primary outcome measure (Mean (SD) of thalamic NAA level)

Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen

To determine the rate of febrile neutropenia in women treated with dose-dense adjuvant chemotherapy receiving pegfilgrastim every 2 weeks.

Proportion of patients achieving >= 2 g/dL Hb increase from baseline or Hb >= 12 g/dL in the Initiation Phase (up to 12 weeks).

Plasma Ferritin at 35-36 weeks PMA

Changes in infarct size as assessed by magnetic resonance imaging 3 months after administration of study medication

To evaluate the efficacy of association of Erythropoetin and ATRA in patients with low risk myelodysplastic syndromes

Erythroid response at 12 weeks according to IWG 2000 (major and minor hematologic improvement) and IWG 2006 criteria

Improvement in indices visual acuity compared to normal course of the disease

To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks

Bleeding time

Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen

Change in local laboratory hemoglobin level from baseline

Number of transfusions; Change from baseline in levels of hemoglobin, hematocrit, reticulocytes (immature red blood cells)

Proportion of patients achieving an erythroid response during the 24-week treatment period.

The proportion of subjects experiencing any delay in any cycle of chemotherapy over the course of the study

Modeled Hemoglobin (Hgb) Change From Baseline (Pre-dose on Day 1) at 4 Weeks of Treatment

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) Events (NCI-CTCAE V5.0).

Change in hemoglobin and hematocrit (laboratory tests used to evaluate the severity of anemia), transfusion requirements, and patient's quality of life assessment.

The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes

Change in Average Hb Concentration Between Baseline and Evaluation Period

Effect on Anemic status (Measurement of Hemoglobin, Hematocrit, serum iron,Total Iron Binding Capacity and serum ferritin)

The primary objective of this study is to describe the PK profiles of six different dosing regimens of epoetin alfa in anemic critically ill subjects, including regimen A, that is being used in a large registration trial

Biological response rate for each group.

Change in Erythropoietin Dose

To characterize the PK of darbepoetin alfa administered at a SC dose of 0.45 mcg/kg TIW in the treatment of anemia in subjects with non-myeloid malignancies receiving multicycle chemotherapy

nerve fiber loss in the optical nerve head determined by optical coherence tomography at weeks 4,8 and 16 compared to baseline. Measurements at baseline and week 16 are used to calculate estimates for changes and differences between the groups.

Fatigue

Change From Baseline in Hemoglobin (Hg) Level at Week 4

Percentage of Participants With Hematological Response of the Erythropoetic System (HI-E) - Core Phase

The Number of Patients Who Developed Peripheral Sensory Neuropathy (National Cancer Institute Common Toxicity Criteria (NCI CTC) Score >= 1) at Week 12.

To assess changes in fatigue in patients at least 18 years old with chronic rheumatoid arthritis (RA) and chronic anemia (Hb < 11.0 g/dL) due to ACD receiving weekly s.c. doses of PROCRIT versus placebo.

Difference in Percentage of Patients Achieving Erythroid Response Within 12 Weeks, by Treatment Group (Full Analysis Set)

days of acute renal failure

To assess the change in physical function from baseline to end of study as measured by the Short Physical Performance Battery (SPPB) summary score.

Incidence of platelet counts exceeding the normal range

The primary endpoint is the hemoglobin response rate, defined as the proportion of subjects who achieve at least a 1 gram per deciliter hemoglobin increase from baseline by Week 17.

The increase from baseline between EPO and saline treated subjects in activity of EPOR-STC including but not limited to, phospho Erk1/2, phospho Akt, activated caspase-3, and activated STAT5 in the second atrial biopsy.

To assess the change in physical function from baseline to end of study as measured by the Short Physical Performance Battery (SPPB) summary score.

Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months

The primary endpoint is the change in composite FIM scores (from entry into the inpatient rehabilitation facility to discharge from inpatient rehabilitation) divided by the LOS, denoted as DFIM/LOS, or "rate of functional recovery".

Change From Baseline in Hemoglobin (Hb) Over Time During the Treatment Period

Transfusion requirements following surgery; Changes in hematocrit, hemoglobin, and reticulocyte count from the start of the study to the end of the study

Clinical response

Anemia correction

Achieving a hemoglobin concentration greater than or equal to 12.0 g/dL or a greater than or equal to 2.0-g/dL increase in hemoglobin concentration compared to baseline

Percentage of margin-free resections produced by each program

Anemia correction

Number of Participants With Change/Improvement Visual Acuity From the Beseline

The primary short-term outcome measures are brain injury (intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL)) and ROP.

Primary endpoint to measure safety, efficacy and acceptability of Erythropoietin medicine

PK Phase: Area-under-the Concentration-time Curve (AUC0-24) for Lenalidomide

Functional status of the participants after 6 months of procedure assessed by modified Rankin Scale.

Change of Functional Independence Measure

Assessment of visual acuity

Safety Endpoints: adverse events; safety laboratory values; immune response by determination of anti-EPO antibodies; dermal safety outcomes

Phase 1b: Maximum Tolerated Dose (MTD)

Total Number of Packed Red Blood Cells Transfused During the Intraoperative and Immediate Postoperative Period

Pharmacokinetic profiling of Aranesp® in HF pts

Mean area under concentration-time curve from time 0 to the last quantifiable concentration (AUClast)

AUC0-t

The primary objective of the study is to describe the pharmacokinetic (PK) profiles of 4 different dosing regimens of PROCRIT in patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

rHuEPO serum concentration

AUC0-t

Serious adverse event

The proportion of subjects free of opportunistic infection attributed to the investigational study regimen

Change in the Renal Blood Flow (RBF ml/min).

An increase in fetal hemoglobin, as measured by high performance liquid chromatograph, from hydroxyurea alone/stabilized baseline to concurrent Erythropoietin in standard therapy/sequence l.

Maximal oxygen-flux (picomol/second)

oxygen saturation in neonates hypoxic ischemic encephalopathy after treatment byerythropoietin