Sample Summary Adverse Events Dataset          
AEDECOD AEBODSYS COUNT_PT NUM_NSAE NUM_SAE NUM_SUB TRTAN TRTA TRT_DESC VERSION AESER
Headache Nervous system disorders 4 3 1 40 1 Drug A Study Drug MedDRA 17.0 No
Back pain Musculoskeletal and connective tissue disorders 16 12 5 40 1 Drug A Study Drug MedDRA 17.1 No
Hypotension Vascular disorders 7 5 3 50 2 Drug B Comparator Drug MedDRA 17.1 Yes
Abdominal discomfort Gastrointestinal disorders 8 8 6 60 3 Drug C Comparator Drug MedDRA 17.1 No
                     
                     
Sample Corresponding Data Entry for Summary AE
Preferred Term AEDECOD
System Organ Class AEBODSYS
Number of Subjects Per Preferred Term COUNT_PT
Treatment Group /Arm ID (Optional) TRTAN
Treatment Group / Arm TRTA
Treatment / Arm Description (Optional) TRT_DESC
Meddra Version VERSION
Total Number of subjects affected by Non-Serious AEs per Treatment Group NUM_NSAE
Total Number of subjects affected by Serious AEs per Treatment Group NUM_SAE
Number of Subjects At Risk Per Treatment Group NUM_SUB
Serious Adverse Events AESER
Serious flag value (ex:"Serious" , "Yes" , 1, etc..) YES
Non-Serious flag value (ex:"Non-Serious", "No", 2 , etc..) NO
         
                     
                     
Sample Exposure Data
SUBJID TREATAN TREATA TREAT_DESC
XYZ-001-001 1 Drug A Study Drug
XYZ-001-002 1 Drug A Study Drug
XYZ-001-003 2 Drug B Comparator Drug
XYZ-001-004 3 Drug C Comparator Drug
XYZ-001-005 3 Drug C Comparator Drug
                     
                     
Sample Corresponding Data Entry for Treatment
Subject Identification SUBJID
Treatment Group / Arm TREATA
Treatment Group / Arm ID (Optional) TREATAN
Treatment Description TREAT_DESC
   
               
                     
Sample Baseline Characteristics Dataset              
PARAM ARM_GROUP_ID ARM_GROUP_TITLE AVAL MEASURE_TITLE UNITOFM    
FEMALE 1 Treatment Arm 1 2 Gender, Male/Female Participants  
FEMALE 2 Treatment Arm 2 101 Gender, Male/Female Participants  
FEMALE 99999999 Total 103 Gender, Male/Female Participants  
MALE 1 Treatment Arm 1 1 Gender, Male/Female Participants  
MALE 2 Treatment Arm 2 95 Gender, Male/Female Participants  
MALE 99999999 Total 96 Gender, Male/Female Participants  
< 18 weeks 1 Treatment Arm 1 3 Age, Customized Participants  
< 18 weeks 2 Treatment Arm 2 196 Age, Customized Participants  
< 18 weeks 99999999 Total 199 Age, Customized Participants  
45-64 weeks 1 Treatment Arm 1 0 Age, Customized Participants  
45-64 weeks 2 Treatment Arm 2 0 Age, Customized Participants  
45-64 weeks 99999999 Total 0 Age, Customized Participants  
>= 65 weeks 1 Treatment Arm 1 0 Age, Customized Participants  
>= 65 weeks 2 Treatment Arm 2 0 Age, Customized Participants  
>= 65 weeks 99999999 Total 0 Age, Customized Participants  
Mean Age 1 Treatment Arm 1 8.7 Age Continuous weeks  
Standard Deviation Age 1 Treatment Arm 1 2.5 Age Continuous weeks  
Mean Age 2 Treatment Arm 2 8.9 Age Continuous weeks  
Standard Deviation Age 2 Treatment Arm 2 2.3 Age Continuous weeks  
Mean Age 99999999 Total 8.9 Age Continuous weeks  
Standard Deviation Age 99999999 Total 2.3 Age Continuous weeks  
Median Age 1 Treatment Arm 1 9 Study Specific Characteristic weeks  
Age Min 1 Treatment Arm 1 6 Study Specific Characteristic weeks  
Age Max 1 Treatment Arm 1 11 Study Specific Characteristic weeks  
Median Age 2 Treatment Arm 2 9 Study Specific Characteristic weeks  
Age Min 2 Treatment Arm 2 0 Study Specific Characteristic weeks  
Age Max 2 Treatment Arm 2 14 Study Specific Characteristic weeks  
Median Age 99999999 Total 9 Study Specific Characteristic weeks  
Age Min 99999999 Total 0 Study Specific Characteristic weeks  
Age Max 99999999 Total 14 Study Specific Characteristic weeks  
WHITE 1 Treatment Arm 1 3 Race, Customized Participants  
WHITE 2 Treatment Arm 2 195 Race, Customized Participants  
WHITE 99999999 Total 198 Race, Customized Participants  
OTHER 1 Treatment Arm 1 0 Race, Customized Participants  
OTHER 2 Treatment Arm 2 1 Race, Customized Participants  
OTHER 99999999 Total 1 Race, Customized Participants  
Median Weight 1 Treatment Arm 1 0 Study Specific Characteristic Kilograms  
Weight Min 1 Treatment Arm 1 0 Study Specific Characteristic Kilograms  
Weight Max 1 Treatment Arm 1 0 Study Specific Characteristic Kilograms  
Median Weight 2 Treatment Arm 2 0 Study Specific Characteristic Kilograms  
Weight Min 2 Treatment Arm 2 0 Study Specific Characteristic Kilograms  
Weight Max 2 Treatment Arm 2 0 Study Specific Characteristic Kilograms  
Median Weight 99999999 Total 0 Study Specific Characteristic Kilograms  
Weight Min 99999999 Total 0 Study Specific Characteristic Kilograms  
Weight Max 99999999 Total 0 Study Specific Characteristic Kilograms  
Mean Weight 1 Treatment Arm 1 0 Study Specific Characteristic Kilograms  
Standard Deviation Weight 1 Treatment Arm 1 0 Study Specific Characteristic Kilograms  
Mean Weight 2 Treatment Arm 2 0 Study Specific Characteristic Kilograms  
Standard Deviation Weight 2 Treatment Arm 2 0 Study Specific Characteristic Kilograms  
Mean Weight 99999999 Total 0 Study Specific Characteristic Kilograms  
Standard Deviation Weight 99999999 Total 0 Study Specific Characteristic Kilograms  
Median Height 1 Treatment Arm 1 0 Study Specific Characteristic centimeters  
Height Min 1 Treatment Arm 1 0 Study Specific Characteristic centimeters  
Height Max 1 Treatment Arm 1 0 Study Specific Characteristic centimeters  
Median Height 2 Treatment Arm 2 0 Study Specific Characteristic centimeters  
Height Min 2 Treatment Arm 2 0 Study Specific Characteristic centimeters  
Height Max 2 Treatment Arm 2 0 Study Specific Characteristic centimeters  
Median Height 99999999 Total 0 Study Specific Characteristic centimeters  
Height Min 99999999 Total 0 Study Specific Characteristic centimeters  
Height Max 99999999 Total 0 Study Specific Characteristic centimeters  
Mean Height 1 Treatment Arm 1 0 Study Specific Characteristic centimeters  
Standard Deviation Height 1 Treatment Arm 1 0 Study Specific Characteristic centimeters  
Mean Height 2 Treatment Arm 2 0 Study Specific Characteristic centimeters  
Standard Deviation Height 2 Treatment Arm 2 0 Study Specific Characteristic centimeters  
Mean Height 99999999 Total 0 Study Specific Characteristic centimeters  
Standard Deviation Height 99999999 Total 0 Study Specific Characteristic centimeters  
TOTAL 1 Treatment Arm 1 3 Study Specific Characteristic    
TOTAL 2 Treatment Arm 2 196 Study Specific Characteristic    
TOTAL 99999999 Total 199 Study Specific Characteristic    
                 
                 
Sample Corresponding Data Entry for Baseline Characteristics                
Parameter Name PARAM              
Treatment Group ID ARM_GROUP_ID              
Treatment Group ARM_GROUP_TITLE              
Parameter Value AVAL              
Measure Title MEASURE_TITLE              
Unit of Measure UNITOFM              
                 
                 
                     
                     
Sample Participant Flow Dataset          
MILESTONE TRTAN TRTA COUNT WITHDRAW_REASON OTHER_REASON PERIOD
Started 1 Drug A 10     Treatment
Completed 1 Drug A 5     Treatment
Withdrew 1 Drug A 2 Adverse Events   Treatment
Withdrew 1 Drug A 1 Deaths   Treatment
Withdrew 1 Drug A 2 other_dc Global deterioration of health status Treatment
Started 2 Drug B 10     Treatment
Completed 2 Drug B 5     Treatment
Withdrew 2 Drug B 2 Adverse Events   Treatment
Withdrew 2 Drug B 1 Deaths   Treatment
Withdrew 2 Drug B 2 other_dc Global deterioration of health status Treatment