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| ID | Type | Description | Link |
|---|---|---|---|
| C3461004 | Other Identifier | Alias Study Number |
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The purpose of the study is to determine the long-term safety in treatment-emergent adverse events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal failure and on hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epoetin Hospira | Experimental | Epoetin Hospira will be administered by IV bolus injection 1 to 3 times per week per each patient's dosing schedule. Other ESAs (except for long-acting) may be used as rescue therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin Hospira | Biological | Intravenous (IV) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Up through 7 days after first dose of study drug (Week 1) |
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Week 1 up to Week 12 |
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Week 13 up to Week 24 |
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Week 25 up to Week 36 |
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48 | Week 1 up to Week 48 | |
| Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL) | Week 1 up to Week 48 | |
| Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL) | Week 1 up to Week 48 |
Inclusion Criteria:
Patient is able to provide written Informed Consent after the risks and benefits of the study have been explained prior to any study-related activities.
Patient previously completed the core study Treatment Period up to and including Week 24 study assessments per protocol and is willing to continue open-label Epoetin Hospira for up to 48 weeks.
If female, patient must be postmenopausal for at least 1 year prior to enrollment, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practicing at least 1 of the following methods of birth control:
If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to enrollment. If the patient is currently using a hormonal contraceptive, she should also use a barrier method during this study and for at least 30 days following the administration of the patient's last open-label dose.
Adequate methods of contraception to prevent pregnancy are to be maintained throughout the course of the study in both male and female study subjects.
Exclusion Criteria:
Patient had a serious or severe adverse event in the core study that, in the opinion of the Investigator, was probably or definitely related to epoetin use and precluded safe use of epoetin.
Any of the following that developed during the core study and prior to enrollment:
A patient with any active, uncontrolled systemic, inflammatory, or malignant disease that developed during the core study and in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to demyelinating diseases such as multiple sclerosis, microbial, viral, or fungal infection or mental disease.
Any newly developed significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including albumin) or any other related drugs that in the judgment of the Investigator is exclusionary for study participation.
A female patient who is pregnant, lactating, or planning a pregnancy during the study.
History of drug abuse or alcohol abuse during the core study prior to enrollment as determined by the Investigator.
Current participation or participation in a drug or other investigational research study within 30 days prior to enrollment (except the core study or any observational studies with prior written approval from Hospira).
May not be able to comply with the requirements of this clinical study, communicate effectively with study personnel, or is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Evidence of human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg).
A patient who, in the Investigator's opinion, has any clinically significant abnormal laboratory results that may impact patient safety.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North America Research Institute | Azusa | California | 91702 | United States | ||
| Bellflower Dialysis Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32734207 | Derived | Wish JB, Rocha MG, Martin NE, Reyes CRD, Fishbane S, Smith MT, Nassar G. Long-term Safety of Epoetin Alfa-epbx for the Treatment of Anemia in ESKD: Pooled Analyses of Randomized and Open-label Studies. Kidney Med. 2019 Aug 28;1(5):271-280. doi: 10.1016/j.xkme.2019.06.009. eCollection 2019 Sep-Oct. |
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Participants with chronic renal failure were receiving Epoetin maintenance therapy in study EPOE-10-01 (NCT01473407) prior to enrollment and treatment in the current study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Epoetin Hospira | Participants were enrolled to receive Epoetin Hospira intravenous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
| Week 37 up to Week 48 |
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Week 1 up to Week 48 |
| Mean Hemoglobin Levels: Over Week 1 to 48 | Week 1 up to Week 48 |
| Mean Hemoglobin Levels for Interval of 12 Weeks | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 |
| Mean Hematocrit Levels: Over Week 1 to 48 | Hematocrit is defined as the percentage of red blood cells in the blood. | Week 1 up to Week 48 |
| Mean Hematocrit Levels for Interval of 12 Weeks | Hematocrit is defined as the percentage of red blood cells in the blood. | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 |
| Percentage of Participants With Hemoglobin Level Outside the Target Range | Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported. | Week 1 up to Week 48 |
| Percentage of Participants Who Received Blood Transfusions | Week 1 up to Week 48 |
| Number of Participants With Clinically Significant Change From Baseline in Hemoglobin Levels | Participants with clinically significant change from baseline in hemoglobin levels were upon investigator's discretion. | Baseline up to Week 48 |
| Number of Participants Who Received Concomitant Medication | Week 1 up to Week 48 |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests | Laboratory tests included: Hematology (hematocrit, hemoglobin, red blood cells count, reticulocytes, white blood cells count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular volume); Coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); Chemistry (blood urine nitrogen, creatinine, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, calcium, gamma-glutyl transpeptidase, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein); iron status (plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory tests were based on investigator's discretion. | Baseline up to Week 48 |
| Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG) | ECG parameters included: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in 12-lead ECGs were based on investigator's discretion. | Baseline up to Week 48 |
| Number of Participants With Clinically Significant Change From Baseline in Physical Examinations | Physical examination included examination of the skin, eyes, ears, nose, throat, head, neck, thyroid, lungs, chest, abdomen, extremities, lymphatic, cardiovascular, musculoskeletal and neurological systems. Participants for any clinically significant changes in physical examination were based on the investigator's discretion. | Baseline up to Week 48 |
| Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies | Percentage of participants with at least 1 positive anti-rhEPO antibody were reported. Radioimmunoprecipitation assay was used to determine the presence of anti-rhEPO antibodies. | Baseline, Week 48 |
| Bellflower |
| California |
| 90706 |
| United States |
| National Institute of Clinical Research | Commerce | California | 90040 | United States |
| DaVita Premier Dialysis Center | Cudahy | California | 90201 | United States |
| Davita - South Valley Dialysis | Encino | California | 91316 | United States |
| Ong, Rubin, Shahmir A Medical Corp DBA: Solano Kidney Care | Fairfield | California | 94533 | United States |
| Fairfield Dialysis Center | Fairfield | California | 94534 | United States |
| Renal Consultants Medical Group | Granada Hills | California | 91344 | United States |
| Advanced Medical Research (Administrative) | Lakewood | California | 90712 | United States |
| Long Beach Clinical Trials | Long Beach | California | 90806 | United States |
| Westcoast Dialysis | Long Beach | California | 90806 | United States |
| DaVita Bixby Knolls Dialysis | Long Beach | California | 90807 | United States |
| United Dialysis Center | Long Beach | California | 90807 | United States |
| Long Beach Dialysis | Long Beach | California | 90813 | United States |
| Imperial Care Dialysis Center | Lynwood | California | 90262 | United States |
| Kidney Research Center | Lynwood | California | 90262 | United States |
| Modesto Kidney Center | Modesto | California | 95350 | United States |
| Novo Research d/b/a Foundation Research | Modesto | California | 95350 | United States |
| Parkway Kindey Center | Modesto | California | 95350 | United States |
| Oakdale Kidney Center | Oakdale | California | 95361 | United States |
| National Institute of Clinical Research | Ontario | California | 91762 | United States |
| Ontario Dialysis Center | Ontario | California | 91762 | United States |
| Paramount Dialysis Center | Paramount | California | 90723 | United States |
| Sierra View Dialysis Center | Porterville | California | 93257 | United States |
| Sierra View District Hospital Dialysis Center | Porterville | California | 93257 | United States |
| Sierra View District Hospital | Porterville | California | 93257 | United States |
| Sierra View Nephrology, Inc. | Porterville | California | CA | United States |
| Nephrology Educational Services and Research, Inc | Tarzana | California | 91356 | United States |
| Santa Clarita Kidney Center | Valencia | California | 91355 | United States |
| American Institute of Research | Whittier | California | 90603 | United States |
| Santa Fe Springs Dialysis | Whittier | California | 90606 | United States |
| Nephrology and Hypertension Associates,PC | Middlebury | Connecticut | 06762 | United States |
| Waterbury Dialysis Center | Waterbury | Connecticut | 06705 | United States |
| Greater Waterbury Dialysis | Waterbury | Connecticut | 06708 | United States |
| Innovative Medical Research of South Florida, Inc, | Aventura | Florida | 33180 | United States |
| West Boca Dialysis Center | Boca Raton | Florida | 33434 | United States |
| Florida Kidney Center | Lauderhill | Florida | 33319 | United States |
| South Florida Research Institute | Laureda Lake | Florida | 33313 | United States |
| Coconut Creek Dialysis JV | Margate | Florida | 33063 | United States |
| American Renal Associates Naples Dialysis Center | Naples | Florida | 34119 | United States |
| Innovative Medical Research of South Florida, Inc. | North Miami Beach | Florida | 33169 | United States |
| Physicians Dialysis of North Beach | North Miami Beach | Florida | 33169 | United States |
| Discovery Medical Research Group, Inc., | Ocala | Florida | 34471 | United States |
| Discovery Medical Research Group, Inc. | Ocala | Florida | 34471 | United States |
| Ocala Regional Kidney Center, East | Ocala | Florida | 34471 | United States |
| Silver Springs Shores Dialysis Center | Ocala | Florida | 34472 | United States |
| Ft. Lauderdale Kidney Center | Plantation | Florida | 33312 | United States |
| Plantation Kidney Center | Plantation | Florida | 33324 | United States |
| Tamarac Kidney Center | Tamarac | Florida | 33321 | United States |
| Dialysis of Dublin | Dublin | Georgia | 31021 | United States |
| Renal Physicians of Georgia, PC | Dublin | Georgia | 31021 | United States |
| Liberty Dialysis/Boise Kidney & Hypertension Institute | Caldwell | Idaho | 83605 | United States |
| Liberty Dialysis/Boise Kidney & Hypertension Institute | Meridian | Idaho | 83642 | United States |
| Pacific Renal Research Institute/Boise Kidney & Hypertension Institute | Meridian | Idaho | 83642 | United States |
| Liberty Dialysis/Boise Kidney & Hypertension Institute | Nampa | Idaho | 83686 | United States |
| Neomedica South | Chicago | Illinois | 60617 | United States |
| FMC Ross Englewood Dialysis | Chicago | Illinois | 60621 | United States |
| Neomedica Evergreen Park | Evergreen Park | Illinois | 60805 | United States |
| Research by Design, LLC | Evergreen Park | Illinois | 60805 | United States |
| North Suburban Nephrology, LLC | Gurnee | Illinois | 60031 | United States |
| Neomedica Round Lake | Round Lake | Illinois | 60073 | United States |
| Clinton Township Dialysis | Clinton Township | Michigan | 48038 | United States |
| Grosse Pointe Dialysis | Detroit | Michigan | 48224 | United States |
| Renaissance Renal Research Institute, LLC | Detroit | Michigan | 48236 | United States |
| Biloxi Dialysis | Biloxi | Mississippi | 39530 | United States |
| FMC/South Mississippi Kidney Center of Gulfport | Gulfport | Mississippi | 39501 | United States |
| South Mississippi Medical Research, PLLC | Gulfport | Mississippi | 39501 | United States |
| Barnes-Jewish Dialysis Center | St Louis | Missouri | 63108 | United States |
| Chromalloy American Kidney Center Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Lower Manhattan Dialysis Center II | New York | New York | 10003 | United States |
| Mountain Kidney and Hypertension Associates, P A | Asheville | North Carolina | 28801 | United States |
| Asheville Kidney Center | Asheville | North Carolina | 28805 | United States |
| ECU Nephrology and Hypertension | Greenville | North Carolina | 27834-2847 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Cincinnati VA Medical Center | Cincinnati | Ohio | 45220 | United States |
| Fresenius Greater Columbus Regional Dialysis Center | Columbus | Ohio | 43215 | United States |
| HNC Dialysis, Ltd. | Columbus | Ohio | 43215 | United States |
| Delaware Valley Nephrology and Hypertension Associates, PC | Philadelphia | Pennsylvania | 19118 | United States |
| Fresenius Medical Care- Mt. Airy Kidney Center | Philadelphia | Pennsylvania | 19118 | United States |
| Fresenius Medical Care - Olney Dialysis Center | Philadelphia | Pennsylvania | 19138 | United States |
| Anderson Dialysis Clinic | Anderson | South Carolina | 29621 | United States |
| AnMed Health | Anderson | South Carolina | 29621 | United States |
| Nephrology and Internal Medicine of Anderson | Anderson | South Carolina | 29621 | United States |
| Columbia Nephrology Associates, P. A. | Columbia | South Carolina | 29203 | United States |
| Columbia Nephrology Associates, PA | Columbia | South Carolina | 29203 | United States |
| Fresenius Medical Care Columbia JV | Columbia | South Carolina | 29203 | United States |
| Fresenius Medical Care Meadowlake JV | Columbia | South Carolina | 29203 | United States |
| Fresenius Medical Care South Columbia JV | Columbia | South Carolina | 29203 | United States |
| Fresenius Medical Care SE Columbia JV | Columbia | South Carolina | 29209 | United States |
| Sumter Dialysis Clinic | Sumter | South Carolina | 29150 | United States |
| Gamma Medical Research Inc. | Edinburg | Texas | 78539 | United States |
| Med Center Dialysis | Houston | Texas | 77004 | United States |
| Fresenius Medical Care Kidney Center | Houston | Texas | 77030 | United States |
| Meyerland Dialysis | Houston | Texas | 77035 | United States |
| Millennium Clinical Research, Inc. | Houston | Texas | 77054 | United States |
| Southwest Houston Dialysis | Houston | Texas | 77071 | United States |
| DaVita North Park | Houston | Texas | 77073 | United States |
| North Shepherd Dialysis Center | Houston | Texas | 77091 | United States |
| Southwest Houston Research, Ltd. | Houston | Texas | 77099 | United States |
| Dialysis Center of Lubbock | Lubbock | Texas | 79430 | United States |
| Fresenius Medical Care McAllen | McAllen | Texas | 78503 | United States |
| Fresenius Medial Care Mission | Mission | Texas | 78572 | United States |
| Missouri City Dialysis | Missouri City | Texas | 77489 | United States |
| NW Medical Center DaVita Dialysis | San Antonio | Texas | 78229 | United States |
| San Antonio Kidney Disease Center Physicians Group, P.L.L.C. | San Antonio | Texas | 78229 | United States |
| Floyd Curl DaVita Dialysis Center | San Antonio | Texas | 78240 | United States |
| Butler Farm Dialysis | Hampton | Virginia | 23666 | United States |
| Peninsula Kidney Associates | Hampton | Virginia | 23666 | United States |
| Consolidated Medical Plaza | Caguas | 00725 | Puerto Rico |
| Fresenius Medical Care·Humacao | Humacao | 00791 | Puerto Rico |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis set included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Epoetin Hospira | Participants were enrolled to receive Epoetin Hospira intravenous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all participants who received at least 1 dose of study drug. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Up through 7 days after first dose of study drug (Week 1) |
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| Primary | Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | Week 1 up to Week 12 |
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| Primary | Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all participants who received at least 1 dose of study drug. Here, ''number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 13 up to Week 24 |
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| Primary | Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all participants who received at least 1 dose of study drug. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 25 up to Week 36 |
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| Primary | Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all participants who received at least 1 dose of study drug. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 37 up to Week 48 |
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| Primary | Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | Week 1 up to Week 48 |
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| Secondary | Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48 | Full analysis set (FAS) included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Unit per kilogram per week (U/kg/week) | Week 1 up to Week 48 |
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| Secondary | Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. | Posted | Mean | Standard Deviation | U/kg/week | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 |
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| Secondary | Mean Hemoglobin Levels: Over Week 1 to 48 | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | g/dL | Week 1 up to Week 48 |
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| Secondary | Mean Hemoglobin Levels for Interval of 12 Weeks | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. | Posted | Mean | Standard Deviation | g/dL | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 |
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| Secondary | Mean Hematocrit Levels: Over Week 1 to 48 | Hematocrit is defined as the percentage of red blood cells in the blood. | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Percentage of red blood cells | Week 1 up to Week 48 |
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| Secondary | Mean Hematocrit Levels for Interval of 12 Weeks | Hematocrit is defined as the percentage of red blood cells in the blood. | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. | Posted | Mean | Standard Deviation | Percentage of red blood cells | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 |
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| Secondary | Percentage of Participants With Hemoglobin Level Outside the Target Range | Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported. | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. | Posted | Number | Percentage of participants | Week 1 up to Week 48 |
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| Secondary | Percentage of Participants Who Received Blood Transfusions | FAS included all enrolled participants and had at least 1 dose of Epoetin Hospira study drug and had at least 1 Hb value. | Posted | Number | Percentage of participants | Week 1 up to Week 48 |
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| Other Pre-specified | Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL) | Safety analysis set included all participants who received at least 1 dose of study drug. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 1 up to Week 48 |
|
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| Other Pre-specified | Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL) | Safety analysis set included all participants who received at least 1 dose of study drug. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 1 up to Week 48 |
|
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| Other Pre-specified | Number of Participants With Clinically Significant Change From Baseline in Hemoglobin Levels | Participants with clinically significant change from baseline in hemoglobin levels were upon investigator's discretion. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | Participants | Baseline up to Week 48 |
|
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| Other Pre-specified | Number of Participants Who Received Concomitant Medication | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | Participants | Week 1 up to Week 48 |
|
| ||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests | Laboratory tests included: Hematology (hematocrit, hemoglobin, red blood cells count, reticulocytes, white blood cells count, neutrophils, bands, lymphocytes, monocytes, basophils, eosinophils, platelets, mean corpuscular volume); Coagulation panel (prothrombin time, international normalized ratio, activated partial thromboplastin time); Chemistry (blood urine nitrogen, creatinine, total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, calcium, gamma-glutyl transpeptidase, phosphorus, uric acid, total protein, glucose, albumin, C-reactive protein); iron status (plasma ferritin, transferrin saturation). Participants with clinically significant change from baseline in laboratory tests were based on investigator's discretion. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | Participants | Baseline up to Week 48 |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Clinically Significant Change From Baseline in 12-Lead Electrocardiogram (ECG) | ECG parameters included: PR interval, QRS complex, QT interval and QTC interval. Participants with clinically significant change from baseline in 12-lead ECGs were based on investigator's discretion. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | Participants | Baseline up to Week 48 |
|
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| Other Pre-specified | Number of Participants With Clinically Significant Change From Baseline in Physical Examinations | Physical examination included examination of the skin, eyes, ears, nose, throat, head, neck, thyroid, lungs, chest, abdomen, extremities, lymphatic, cardiovascular, musculoskeletal and neurological systems. Participants for any clinically significant changes in physical examination were based on the investigator's discretion. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | Participants | Baseline up to Week 48 |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Anti-Recombinant Human Erythropoietin (Anti-rhEPO) Antibodies | Percentage of participants with at least 1 positive anti-rhEPO antibody were reported. Radioimmunoprecipitation assay was used to determine the presence of anti-rhEPO antibodies. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | Percentage of participants | Baseline, Week 48 |
|
|
Not provided
The same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Safety Population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epoetin Hospira | Participants were enrolled to receive Epoetin Hospira intravenous injection 1 to 3 times every week over a period of 48 weeks. Dose was adjusted to maintain the hemoglobin (Hb) level from 9 to 11 gram per deciliter (g/dL). | 168 | 406 | 277 | 406 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastrointestinal angiodysplasia | Congenital, familial and genetic disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastrointestinal arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Localised intraabdominal fluid collection | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous fistula site infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous graft site infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cardiac valve abscess | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cystitis escherichia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nocardiosis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Peridiverticular abscess | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Traumatic haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vascular pseudoaneurysm ruptured | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diabetic foot | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Breast cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Non-small cell lung cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diabetic hyperosmolar coma | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Unresponsive to stimuli | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment | This event was gender specific event. |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 14.1 | Non-systematic Assessment | This event was gender specific event. |
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arterial thrombosis limb | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Ischaemic limb pain | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Malignant hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vascular occlusion | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single centre publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer, Inc. | Pfizer ClinicalTrials.gov Call Center | 1--800--718--1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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