ࡱ>  }bjbj  *hh2%UXS)S)S))))+ ,L)b|dW0V2p333;zNL]S{{{{{{{$~h{9S)Wu;";WW{33X{<^e^e^eW3S)3{^eW{^e^esh%tWt3\)Xsk{|Hb|spZ WtWt4S)uVZ_V@^eV4VVVV{{*b4VVVb|WWWWVVVVVVVVV :  DSMB Report Template -Closed Session- For Multi-Site Studies Title Page (Title of the study, PI) Table of Contents  TOC \o "1-4" \h \z \u  HYPERLINK \l "_Toc192645892" Title Page  PAGEREF _Toc192645892 \h i  HYPERLINK \l "_Toc192645893" Table of Contents  PAGEREF _Toc192645893 \h ii  HYPERLINK \l "_Toc192645894" Closed Session Report Summary  PAGEREF _Toc192645894 \h 1  HYPERLINK \l "_Toc192645896" Recruitment and Participant Status: Figure and Tables  PAGEREF _Toc192645896 \h 2  HYPERLINK \l "_Toc192645897" Figure 1: Overall Study Status by Treatment Group  PAGEREF _Toc192645897 \h 3  HYPERLINK \l "_Toc192645898" Table 5: Demographic and Key Baseline Characteristics by Blinded Treatment Group  PAGEREF _Toc192645898 \h 4  HYPERLINK \l "_Toc192645899" Table 6: Treatment Duration for All Participants  PAGEREF _Toc192645899 \h 5  HYPERLINK \l "_Toc192645900" Safety Assessments: Tables and Listings  PAGEREF _Toc192645900 \h 6  HYPERLINK \l "_Toc192645902" Table 10: Incidence of Adverse Events by Body System, Preferred Term and Treatment Group  PAGEREF _Toc192645902 \h 7  HYPERLINK \l "_Toc192645903" Table 11: Severity of Adverse Events by Preferred Term and Treatment Group  PAGEREF _Toc192645903 \h 8  HYPERLINK \l "_Toc192645904" Listing 1: Serious Adverse Events by Treatment Group  PAGEREF _Toc192645904 \h 9  HYPERLINK \l "_Toc192645905" Listing 2: Deaths by Treatment Group  PAGEREF _Toc192645905 \h 10  HYPERLINK \l "_Toc192645906" Listing 3: Adverse Events by Treatment Group  PAGEREF _Toc192645906 \h 11  HYPERLINK \l "_Toc192645909" Table 12a: Laboratory Test Results Summary Treatment Group A  PAGEREF _Toc192645909 \h 12  HYPERLINK \l "_Toc192645910" Table 12b: Laboratory Test Results Summary Treatment Group B  PAGEREF _Toc192645910 \h 13  HYPERLINK \l "_Toc192645911" Listing 4: Clinically Significant Abnormal Lab Values  PAGEREF _Toc192645911 \h 14  * Please note that the tables are numbered based on the corresponding Open session tables for consistency. Only tables that are applicable to Closed session need to be included here. The final format of the reports, tables, and listings are to be determined by the Data and Safety Monitoring Board. Closed Session Report Summary Study Administration Recruitment and Participant Status: Figure and Tables Figure 1: Overall Study Status by Treatment Group  Table 5: Demographic and Key Baseline Characteristics by Blinded Treatment Group Data as of:_________ Date of report:_________ Characteristics Group A n (%) Group B n (%) Total N Total Enrolled:Gender Male FemaleEthnicity Hispanic or LatinoNot Hispanic or LatinoUnknown or not reportedRace American Indian/Alaska NativeAsianBlack or African AmericanNative Hawaiian or OtherPacific IslanderWhiteMore than one raceUnknown or not reportedClinical Features/ Stratification BMI e" 30*Age  MeanMedianStandard DeviationMinimumMaximum * This is an example, needs to be protocol specific. Table 6: Treatment Duration for All Participants Data as of:_________ Date of report:_________ Time in Study*Group A: nGroup A: %Group B: nGroup B: %TotalVisit 1Visit 2Visit 3Visit 4Completed Study * Needs to be protocol specific and can be shown by visits, days, weeks, months, or treatment periods. Final format and content is determined by DSMB. Safety Assessments: Tables and Listings Table 10: Incidence of Adverse Events by Body System, Preferred Term and Treatment Group Data as of:_________ Date of report:_________ Body System and Preferred TermGroup A N=n*Group A N=%**Group A N=Events***Group B N=n*Group B N=%**Group B N=Events***OverallCardiovascularMyocardial InfarctionIncreased Blood Pressureetc.GenitourinaryYeast InfectionVaginal Bleedingetc.Gastrointestinaletc.* Number of participants experiencing an adverse events (participant is to be counted only once for each adverse event) in a Treatment Group ** % of total number of participants in the study *** Number of events for Body System and Preferred Term This table can present overall incidence of adverse events as shown above; or adverse events related to the intervention as judged by the investigator; or treatment emergent events. Table 11: Severity of Adverse Events by Preferred Term and Treatment Group Data as of:_________ Date of report:_________ Preferred Term*Group A N=Mild n** (%)***Group A N=Moderate n (%)Group A N=Severe n (%)Group B N=Mild n** (%)***Group B N=Moderate n (%)Group B N=Severe n (%)HeadachePainetc. * For preferred term, sort by most common event in descending order of incidence ** Number of participants experiencing a certain severity of an adverse event where each participant is counted once at the highest level of severity for the event. *** % of participants experiencing a certain severity of an adverse event within Treatment Group This table can present severity of all adverse events sorted by preferred term in descending order of incidence as shown above; or adverse events related to the intervention as judged by the investigator; or treatment emergent events. Listing 1: Serious Adverse Events by Treatment Group Data as of:_________ Date of report:_________ SiteTreatment GroupParticipant IDOnset DateStop DateExpected (Y/N)Relationship to Intervention* (Y/N)Outcome**Description of SAE * Definite, Possible, Not Related ** Outcome: Recovered, without treatment Recovered, with treatment Still Present, no treatment Still Present, being treated Residual effect(s) present no treatment Residual effect(s) present- being treated Subject died SiteTreatment GroupParticipant IDDate of DeathCause of DeathRelationship to Intervention* Listing 2: Deaths by Treatment Group Data as of:_________ Date of report:_________ * Definite, Possible, Not Related Listing 3: Adverse Events by Treatment Group* Data as of:_________ Date of report:_________ SiteTreatment GroupParticipant IDDays on Intervention Preferred TermRelationship to Intervention** SeveritySerious (Y/N)Outcomes*** * This listing could be sorted by Preferred Term or by Treatment Group. ** Definite, Possible, Not Related *** Outcome: Recovered, without treatment Recovered, with treatment Still Present, no treatment Still Present, being treated Residual effect(s) present no treatment Residual effect(s) present- being treated Subject died Table 12a: Laboratory Test Results Summary Treatment Group A* Data as of:_________ Date of report:_________ Laboratory TestSample Study VisitsNMeanSDMinMedianMaxNMeanSDMinMedianMaxTest 1Screening6 Months12 Months24 Months36 MonthsTest 2Screening6 Months12 Months24 Months36 MonthsEtcScreening6 Months12 Months24 Months36 Months---------------Change from Baseline-------------- * Table may include lab test results that are clinically significant, as defined by the protocol, or ALL lab test results. Final format is determined by the DSMB. Table 12b: Laboratory Test Results Summary Treatment Group B* Data as of:_________ Date of report:_________ ---------------Change from Baseline-------------- Laboratory TestSample Study VisitsNMeanSDMinMedianMaxNMeanSDMinMedianMaxTest 1Screening6 Months12 Months24 Months36 MonthsTest 2Screening6 Months12 Months24 Months36 MonthsEtcScreening6 Months12 Months24 Months36 Months* Table may include lab test results that are clinically significant, as defined by the protocol, or ALL lab test results. Final format is determined by the DSMB. Listing 4: Clinically Significant Abnormal Lab Values Data as of:_________ Date of report:_________ SiteTreatment GroupParticipant IDVisitAgeGenderLab PanelLab TestResult     3/24/08 DSMB Report Template- Multi-Site Closed Session- Version 1.0  PAGE 2 Study Name: Principal Investigator: 3/24/08 DSMB Report Template- Multi-Site Closed Session- Version 1.0  PAGE 3 3/24/08 DSMB Report Template- Multi-Site Closed Session- Version 1.0  PAGE 6 Study Name: Principal Investigator: 3/24/08 DSMB Report Template- Multi-Site Closed Session- Version 1.0  PAGE 9 ,DEFGITUclm|}~طtdTdG@9t1h@DCJ4aJ4 hj8NhoI hj8Nh@Dh%5OJQJ\^Jhj8NhoI5OJQJ\^Jhj8Nh@D5OJQJ\^Jh h@DCJ4aJ4#hj8Nh@D5CJ4OJQJ^JaJ4&h h@D5CJ4OJQJ\^JaJ4#h hRl5CJ4OJQJ^JaJ4h>f5OJQJ\^J&hj8Nh*5CJ4OJQJ\^JaJ4&hj8Nh(5CJ4OJQJ\^JaJ4&hj8NhV;w5CJ4OJQJ\^JaJ4,-DEFGHITU$[$\$a$gd@DgdG~S$8[$\$^8a$gd@Dgd!t x^gd`$[$\$a$gd+%)$[$\$a$gd($[$\$a$gd>TQUnopqrstuvwxyz{|~L $ #gd:}gd:}gd+gdD>gdG~Sgd%@ [$\$^@ `gdoI    ) * + E F G I J K L M N j k ׾ׂ׾wjwhz)lU'jhh+>*B*Uphh+5OJQJ\]^J h7j}hz)lUjh+U h+'jhh+>*B*Uphhh+0Jjhh+0JUh+jh+U hD>hD>(k l m     лƶިqj^PFh:}h+5jh:}h+5Uh }h }0J5 hsiC0J5*jh:}h+5>*B*Uphh:}h+5h:}h+0J5jh:}h+0J5Uh+5OJQJ\]^J h7jqhz)lUjh+U h+hh+0Jjhh+0JU'jhh+>*B*Uph  ! 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