Conditions: Myelodysplastic Syndrome (MDS)
Keywords: Myelodysplastic Syndrome (MDS) Darbepoetin alfa low risk MDS intermediate-1 risk MDS International Prognostic Scoring System (IPSS)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 9
Healthy volunteers: no

Brief summary:
The primary objective of the study was to provide required access of investigational product (darbepoetin alfa) beyond the end of the active treatment period (EOATP) of the darbepoetin alfa MDS 20090160 (NCT01362140) study for patients who had continued demonstration of benefit from darbepoetin alfa treatment and to describe the safety of longer-term use in this patient population.

Detailed description:
This is a phase 3b, multi-centre, open-label, single-arm companion study to the MDS 20090160 study (NCT01362140) for the treatment of anaemic patients with MDS. Participants who completed the active-treatment period of the darbepoetin alfa MDS 20090160 study and met the eligibility criteria could be enrolled into this study to continue treatment of darbepoetin alfa for up to 73 weeks or until progression to acute myelogenous leukemia (AML), whichever occurs first.

Arms:
arm 1: Participants received darbepoetin alfa for up to 73 weeks or until progression to acute myeloid leukemia (AML), whichever occurred first.

Interventions: intervention 1: Darbepoetin Alfa
Intervention descriptions: intervention 1: The first dose of darbepoetin alfa was the same as that administered at the last dosing visit of the active treatment period in Study 20090160. Doses could be increased up to a maximum of 500 μg every two weeks (Q2W).

Protocol document:
Prot_002.pdf: 
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SAP_001.pdf: 
Product: Darbepoetin alfa 
Statistical Analysis Plan: 20130113 
Version 1.0, Date: 12 June 2014 
Page 1 of 8 
 
 
 
 
 
 
STATISTICAL ANALYSIS PLAN 
 
Primary Analysis for the Companion Study for Darbepoeitin Alfa Study 20090160 
 
 
 
 
 
 
 
 
Protocol Number : 
20130113 
Version: 
1.0 
Date: 
12 June 2014 
Authors: 
PPD  
 
 
 
 
Does this Statistical Analysis Plan document any analysis with the objective to claim 
pre-specification? 
 
 Yes 
 
 No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCT Number: 02175277 
This NCT number has been applied to the document 
for purposes of posting on clinicaltrials.gov 


Product: Darbepoetin alfa 
Statistical Analysis Plan: 20130113 
Version 1.0, Date: 12 June 2014 
Page 2 of 8 
 
 
 
 
 
Table of Contents 
 
1. 
INTRODUCTION...................................................................................................... 5 
 
2. 
OBJECTIVES ........................................................................................................... 5 
2.1 
Definitions..................................................................................................... 5 
 
3. 
COVARIATES .......................................................................................................... 7 
 
4. 
ENDPOINT CATEGORIES AND ANALYSES.......................................................... 7 
4.1 
Safety Endpoints .......................................................................................... 7 
4.1.1 
Endpoints...................................................................................... 7 
4.1.2 
Analysis Methods ......................................................................... 7 
 
5. 
LIST OF PLANNED TABLES, FIGURES, AND LISTINGS ...................................... 7 


Product: Darbepoetin alfa 
Statistical Analysis Plan: 20130113 
Version 1.0, Date: 12 June 2014 
Page 3 of 8 
 
 
 
 
Table of Abbreviations 
 
Abbreviation or Term 
Definition/Explanation 
ACS 
Acute coronary syndrome 
AE 
Adverse Event 
AML 
Acute myelogenous leukemia 
ATE 
Arterial thromboembolic event 
Baseline hemoglobin 
Hemoglobin value measured on study day 1 (the day of first 
administration of IP) before administration of IP and assessed by the 
local laboratory 
CRF 
Case report form 
CTCAE 
Common Terminology Criteria for Adverse Events 
DVT 
Deep vein thrombosis 
End of study (EOS) 
Subjects will not receive IP beyond week 73. The overall end of 
study will occur once all subjects enrolled and dosed with IP either 
withdraw from the study early, die, or complete the treatment period 
of the study. The end of study for an individual subject will occur 
either when the subject is withdrawn from the study, dies, or 
completes the final EOS visit. 
End of the active 
treatment period visit 
(EOATP) 
The final required visit in the MDS 20090160 study for subjects that 
complete IP treatment per protocol through week 72 / 73. Only 
subjects that complete all IP treatment in the MDS 20090160 study 
are potentially eligible to participate in the 20130113 study. 
Enroll, Enrolled, or 
Enrollment 
Enrollment is defined as the point in time when the subject has 
completed required screening procedures, all eligibility criteria are 
met, and the subject receives the first dose of IP on day 1 / week 1. 
ESA 
Erythropoiesis-stimulating agent 
g/dL 
Grams per deciliter 
Hb 
Hemoglobin 
ICF 
Informed consent form 
IP 
Investigational product 
MDS 
Myelodysplastic syndrome 
PE 
Pulmonary embolism 
RBC transfusion 
Red blood cell transfusion 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SMQ 
Standardized MedDRA query 


Product: Darbepoetin alfa 
Statistical Analysis Plan: 20130113 
Version 1.0, Date: 12 June 2014 
Page 4 of 8 
 
 
 
 
Abbreviation or Term 
Definition/Explanation 
 
Source Data 
Information from an original record or certified copy of the original 
record containing patient information for use in clinical research. 
The information may include, but is not limited to, clinical findings, 
observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the trial. Source data are contained 
in source documents (original records or certified copies). [ICH 
Guideline (E6)]. 
 
Study day 1 
The first day that protocol specified IP is administered to the subject; 
Day 1 t is expected to align with the end of the active treatment 
period visit of the MDS 20090160 study (window +10 days) 
 
TIA 
Transient ischemic attack 
 
TVE 
Thrombovascular event 
 
µg 
Microgram 
 
VTE 
Venous thromboembolic event 
 
WHO 
World Health Organization 


Product: Darbepoetin alfa 
Statistical Analysis Plan: 20130113 
Version 1.0, Date: 12 June 2014 
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1. 
INTRODUCTION 
 
This statistical analysis plan (SAP) outlines the statistical analyses to be performed for 
Amgen protocol 20130113 entitled A Single Arm, Companion Study to Myelodysplastic 
Syndrome (MDS) 20090160 Using Darbepoetin alfa for the Treatment of Anaemic 
Subjects With Myelodysplastic Syndrome. The analyses summarized here are beyond 
the analyses described within the SAP version 3.0, dated on 30 September 2013 for 
data collected within the scope of Amgen protocol 20090160 entitled A Multicenter, 
Randomised, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the 
Treatment of Anaemic Subjects with Low or Intermediate-1 Risk Myelodysplastic 
Syndromes (MDS). The objective of this SAP is to pre-specify non Clinical Study Report 
 
(CSR) -related analyses. 
 
 
2. 
OBJECTIVES 
 
The primary objective of this study is to provide required access of investigational 
product (darbepoetin alfa) beyond the end of active treatment period of the 
darbepoetin alfa MDS 20090160 study for subjects that have continued demonstration of 
benefit from darbepoetin alfa treatment and to describe the safety of longer-term use in 
this patient population. Treatment with darbepoetin alfa may continue for up to 73 weeks 
or until progression to AML, whichever occurs first. 
 
2.1 
Definitions 
 
Progression to Acute Myelogenous Leukemia (AML) 
 
Progression to AML in this study will be assessed according to World Health 
Organization (WHO) guidelines (peripheral or blast cells ≥ 20%, presence of 
pathognomonic AML cytogenetic change, or evidence of marrow blast criteria for 
erythroleukemia). 
 
Red Blood Cell (RBC) Transfusions 
 
This is defined as any RBC transfusion (includes packed RBCs or whole blood and 
excludes platelets) given during an assessment period, regardless of hemoglobin 
concentration level at the time of transfusion or reason for transfusion.  Subjects with at 
least 1 RBC transfusion during the assessment period will be considered “transfused”. 
Subjects with no RBC transfusions during the assessment period will be considered “not 
transfused”. 


Product: Darbepoetin alfa 
Statistical Analysis Plan: 20130113 
Version 1.0, Date: 12 June 2014 
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Treatment-emergent Adverse Event 
 
A treatment-emergent adverse event (AE) is any event reported via the AE summary 
case report form (CRF) with an onset date between study day 1 and EOS. 
 
• 
A treatment-emergent serious adverse event (SAE) is any event reported with an 
onset date between the date the subject signs the Informed Consent Form (ICF) 
through 30 days after the last dose of IP. 
 
• 
Day 1 / week 1 dosing visit is expected to align with the end of the active 
treatment period (EOATP) visit of the MDS 20090160 study (window +10 days) 
 
• 
End of Study visit performed 3 weeks ± 7 days after last dose of IP. 
 
 
Thrombovascular event (TVE) 
 
Thrombovascular events are adverse events that include arterial thromboembolic events 
(ATEs) and venous thromboembolic events (VTEs). These events will be coded using 
MedDRA version 17 (or higher) and identified using a Standardized MedDRA Query 
(SMQ 20000081, “embolic and thrombotic events” excluding terms from the 
sub-SMQ 20000083, “embolic and thrombotic events, vessel type unspecified and mixed 
arterial and venous”) or more appropriate query available at the time of analysis.  ATEs 
and VTEs are described below: 
 
• 
Arterial thromboembolic event (ATE) 
 
ATEs include stroke, transient ischemic attack (TIA), acute coronary syndromes 
(ACS), and other arterial thrombosis/embolism. These events will be coded 
using MedDRA version 17 (or higher) and identified using the 
sub-SMQ 20000082 (“embolic and thrombotic events, arterial”) or more 
appropriate query available at the time of analysis. 
 
• 
Venous thromboembolic event (VTE) 
 
VTEs include deep vein thrombosis (DVT), pulmonary embolism (PE), and other 
venous thrombosis excluding superficial venous thrombosis. These events will 
be coded using MedDRA version 17 (or higher) and identified using the 
sub-SMQ 20000084 (“embolic and thrombotic events, venous”) or more 
appropriate query available at the time of analysis.  In addition, VTEs will be 
distinguished by whether or not they were confirmed by imaging.  The primary 
analysis of VTEs will include fatal VTEs and VTEs confirmed by imaging; a 
sensitivity analysis will summarize all VTEs regardless of severity or 
confirmation. 


Product: Darbepoetin alfa 
Statistical Analysis Plan: 20130113 
Version 1.0, Date: 12 June 2014 
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3. 
COVARIATES 
 
No covariates will be used in the analysis of the study. 
 
 
4. 
ENDPOINT CATEGORIES AND ANALYSES 
 
4.1 
Safety Endpoints 
 
4.1.1 
Endpoints 
 
Primary Endpoint: Subject incidence of treatment-emergent adverse events 
 
 
4.1.2 
Analysis Methods 
 
Total enrollment is projected to be less than 10 subjects from 1 country. Given the small 
population, no summary statistics (descriptive or otherwise) will be provided.  Listings 
will be provided for patient disposition data, baseline demographics, baseline 
characteristics, IP administration, and important protocol deviations.  Listings will also be 
generated for the primary endpoint of all treatment-emergent adverse events by system 
organ class and preferred term.  In addition, listings will be provided, by system organ 
class and preferred term, of all fatal adverse events, serious adverse events, adverse 
events leading to withdrawal from IP and significant treatment emergent adverse events. 
Progression to AML will also be summarized in a listing. 
 
Listings of subjects who develop anti-darbepoetin alfa antibodies (binding and if positive, 
neutralizing) at any time will also be provided. 
 
Missing data will not be imputed.  Data collected in the study will not be combined with 
 
Amgen 20090160 study data. 
 
 
5. 
LIST OF PLANNED TABLES, FIGURES, AND LISTINGS 
 
The following listings will be provided: 
 
• 
Listing of demographics and baseline characteristics including: enrollment date, 
sex, age at enrollment, height, weight, heart rate, temperature, blood pressure, 
and hemoglobin at enrollment 
 
• 
Listing of treatment emergent adverse events and significant treatment emergent 
adverse events by system organ class and preferred term 
 
• 
Listing of fatal adverse events by system organ class and preferred term 
 
• 
Listing of serious adverse events by system organ class and preferred term 
 
• 
Listing of adverse events leading to withdrawal from IP by system organ class 
and preferred term 
 
• 
Listing of subjects that progressed to AML 
 
• 
Listing of exposure to IP may include:  the number of weeks of dosing, the total 
number of doses, the average weekly dose (µg/week), the average dose 


Product: Darbepoetin alfa 
Statistical Analysis Plan: 20130113 
Version 1.0, Date: 12 June 2014 
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administered (µg/dose), the cumulative dose administered (µg), the 
weight-adjusted average dose administered (µg/kg/dose), and the 
weight-adjusted cumulative dose administered (µg/kg) 
 
• 
Listing of Important Protocol Deviations 
 
• 
Listing of all RBC transfusions given on-study 
 
• 
Listing of development of anti-darbepoetin alfa antibodies (binding and if positive, 
neutralizing) at any timepoint 
 
• 
Listing of Thrombovascular Events including: 
 
o Arterial thromboembolic events [ATEs]: stroke; transient ischemic 
attack [TIA]; acute coronary syndromes [ACS]; other arterial 
thrombosis/embolism; 
 
o Venous thromboembolic events [VTEs]: deep vein thrombosis [DVT]; 
pulmonary embolism [PE]); and other venous thrombosis (excluding 
superficial venous thrombosis).