Observational Study to Investigate the Long-term Effects... | NCT01309269

NCT01309269

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemoglobin Levels at Monthly Intervals	Hemoglobin levels were measured as grams/deciliter (g/dL).	Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Percentage of Participants Within Pre-defined Range of Hemoglobin Values	Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10-12 g/dL, 11-13 g/dL, and 10-13 g/dL.	Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
Average Methoxy Polyethylene Glycol-epoetin Beta Dose	Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.	Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

In this non-interventional study, physician was completely free in his/her decision which participants he/she treated with the medication selected in this study, what dosage was chosen, which diagnostic measures were taken, how the course of treatment was monitored and what accompanying or supplemental medications were prescribed.

Arm/Group Information

ID	Title	Description
FG000	Methoxy Polyethylene Glycol-epoetin Beta	Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0001085 subjects
Treated		FG000978 subjects
COMPLETED		FG000245 subjects
NOT COMPLETED		FG000840 subjects

Type	Comment	Reasons
Adverse Event		FG00056 subjects
Withdrawal by Subject		FG00025 subjects
Lack of Acceptance		FG00015 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Methoxy Polyethylene Glycol-epoetin Beta	Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Hemoglobin Levels at Monthly Intervals

Hemoglobin levels were measured as grams/deciliter (g/dL).

Effectiveness Population I: all participants for whom at least 1 hemoglobin value was documented after the first application of methoxy polyethylene glycol-epoetin beta during the study course. N (number of participants analyzed) = participants evaluable for this measure. n = participants with hemoglobin values during study period considered.

Posted

Mean

Standard Deviation

g/dL

Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

ID	Title	Description
OG000	Methoxy Polyethylene Glycol-epoetin Beta	Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Methoxy Polyethylene Glycol-epoetin Beta	Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.0	Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Medical Communications	Hoffmann-LaRoche	800-821-8590		genentech@druginfo.com

Condition Browse Module

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases