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Monitoring of Side Effects System

119 Shared Subjects

N/A
Clinical Assessments
Side Effects
01/25/2017
moses01
01/25/2017
View Change History
01
Query Element Name Data Type Size Required Description Value Range Notes Aliases
subjectkey GUID Required The NDAR Global Unique Identifier (GUID) for research subject NDAR*
src_subject_id String 20 Required Subject ID how it's defined in lab/project
interview_age Integer Required Age in months at the time of the interview/test/sampling/imaging. 0::1440 Age is rounded to chronological month. If the research participant is 15-days-old at time of interview, the appropriate value would be 0 months. If the participant is 16-days-old, the value would be 1 month.
interview_date Date Required Date on which the interview/genetic test/sampling/imaging/biospecimen was completed. MM/DD/YYYY
sex String 20 Required Sex of subject at birth M;F; O; NR M = Male; F = Female; O=Other; NR = Not reported gender
site String 101 Recommended Site Study Site
Query week Float Recommended Week in level/study 99=week 10-week 14
Query rand_num Integer Recommended Randomization Number 0::2
Query daysrz Integer Recommended days since randomization
Query mos_ee_bvis Integer Recommended Eyes Blurred Vision 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_ee_dvis Integer Recommended Eyes Double Vision 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_ee_roll Integer Recommended Eyes Rolled Up 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_ee_rapid Integer Recommended Rapid Eye Movement 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_ee_ring Integer Recommended Ringing in Ears 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_gi_cramp Integer Recommended Abdominal Pain or Cramps 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_gi_deapp Integer Recommended Decreased Appetite / Anorexia 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_gi_inapp Integer Recommended Increased Appetite 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_gi_const Integer Recommended Constipation 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_gi_diarr Integer Recommended Diarrhea 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_gi_drool Integer Recommended Drooling / Salivation 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_gi_dry Integer Recommended Dry Mouth 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_gi_gas Integer Recommended Gas / Indigestion 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_gi_gum Integer Recommended Gum Growth 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_gi_naus Integer Recommended Nausea 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_gi_taste Integer Recommended Taste: Abnormal / Metallic 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_gi_thrst Integer Recommended Increase Thirst 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_gi_vomit Integer Recommended Vomiting 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_cont Integer Recommended Contortions / Spasticity 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_imbal Integer Recommended Gait: Imbalance / Unsteady 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_shuff Integer Recommended Gait: Shuffling 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_pain Integer Recommended Musculoskeletal Pain 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_head Integer Recommended Headache 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_pace Integer Recommended Pacing / Restlessness 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_writh Integer Recommended Limb jerking / Writhing 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_mouth Integer Recommended Tongue and Mouth Movements 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_mask Integer Recommended Mask-like, Expressionless Face 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_arch Integer Recommended Neck / Back Arching 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_pill Integer Recommended Pill Rolling 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_rigid Integer Recommended Rigidity 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_slur Integer Recommended Slurred Speech 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_nm_trem Integer Recommended Tremor 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_pg_jitt Integer Recommended Agitation / Jitters 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_pg_anxty Integer Recommended Anxiety 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_pg_dconc Integer Recommended Attention/Concentration: Decrease 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_pg_confs Integer Recommended Confusion 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_pg_deprs Integer Recommended Depression 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_pg_drows Integer Recommended Drowsiness / Sedation 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_pg_irrit Integer Recommended Irratability 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_pg_leth Integer Recommended Lethargy / No Movement 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_pg_sleep Integer Recommended Sleep: Excessive 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_pg_insom Integer Recommended Insomnia / Less Sleep 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_pg_weak Integer Recommended Weakness / Fatigue 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_r_breath Integer Recommended Difficult or Labored Breathing 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_r_congst Integer Recommended Nasal Congestion 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_s_acne Integer Recommended Acne 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_s_abhair Integer Recommended Abnormal Hair Growth 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_s_pale Integer Recommended Pale or Pallor Skin Color 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_s_yellow Integer Recommended Yellow Skin Color 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_s_dry Integer Recommended Itching or Dry Skin 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_s_puffy Integer Recommended Puffy Skin / Tissue Fluid 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_s_rash Integer Recommended Rash or Hives 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_s_sburn Integer Recommended Sunburn / Photosensitivity Skin 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_s_sweat Integer Recommended Increased Sweating 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_u_brgrow Integer Recommended Swelling or Growth in Breast 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_u_brdis Integer Recommended Breast Discharge 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_u_abmens Integer Recommended Menstrual Absence 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_u_irmens Integer Recommended Menstrual Irregularities 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_u_decsex Integer Recommended Sexual: Decreased / Impotence 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_u_incsex Integer Recommended Sexual: Increased 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_u_deurin Integer Recommended Urinary: Decreased / Retention 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_u_difurn Integer Recommended Urinary: Difficult / Painful 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_u_nocurn Integer Recommended Urinary: Enuresis / Nocturesis 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_u_inurin Integer Recommended Urinary: Increased 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_wb_seize Integer Recommended Convulsions / Seizures 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_wb_dizzy Integer Recommended Fainting / Dizziness 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_wb_vert Integer Recommended Vertigo 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_wb_fever Integer Recommended Fever 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_wb_throa Integer Recommended Sore Throat 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_wb_wgain Integer Recommended Weight Gain 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_wb_wloss Integer Recommended Weight Loss 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_o_pain Integer Recommended Pain 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_o_chest Integer Recommended Chest Pain 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
mos_o_traumas String 50 Recommended Trauma Specify Specified
Query mos_o_trauma Integer Recommended Trauma 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_o_other1 Integer Recommended Other SE 1 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
mos_other1s String 50 Recommended Other SE1 : Specify Symptom Symptom name
Query mos_o_other2 Integer Recommended Other SE 2 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
mos_other2s String 50 Recommended Other SE 2: Specify Symptom Symptom name
Query mos_hyper Integer Recommended Hyperactivity 0::5 0=not present; 1=minimal; 2=mild; 3=moderate; 4=severe; 5=FDA "Serious" AE
Query mos_ae_occur Integer Recommended Did an Adverse Event Occur? 1;0 1=yes; 0=no
Query mos_ae_death Integer Recommended Adverse Event - death 0;1 1=checked, otherwise blank
Query mos_ae_hosp Integer Recommended Adverse Event - hospitalization 0;1 1=checked, otherwise blank
Query mos_ae_lifeth Integer Recommended Adverse Event - life threatening medical problem 0;1 1=checked, otherwise blank
Query mos_ae_disab Integer Recommended Adverse Event - long-term disability 0;1 1=checked, otherwise blank
Query mos_ae_deform Integer Recommended Adverse Event - congenital deformity 0;1 1=checked, otherwise blank
Query mos_total Float Recommended MOSES Total Summary Score 0::375
Query mos_ee_sub Float Recommended Eyes and Ears Mean Sub Score 0::5
Query mos_gi_sub Float Recommended Gastrointestinal Mean Sub Score 0::5
Query mos_nm_sub Float Recommended Neurological/Muscle Mean Sub Score 0::5
Query mos_pg_sub Float Recommended Psychological Mean Sub Score 0::5
Query mos_r_sub Float Recommended Respiratory Mean Sub Score 0::5
Query mos_s_sub Float Recommended Skin Mean Sub Score 0::5
Query mos_u_sub Float Recommended Urinary Mean Sub Score 0::5
Query mos_wb_sub Float Recommended Whole Body Mean Sub Score 0::5
Query mos_mean Float Recommended MOSES Total Mean Score 0::5
Data Structure

This page displays the data structure defined for the measure identified in the title and structure short name. The table below displays a list of data elements in this structure (also called variables) and the following information:

  • Element Name: This is the standard element name
  • Data Type: Which type of data this element is, e.g. String, Float, File location.
  • Size: If applicable, the character limit of this element
  • Required: This column displays whether the element is Required for valid submissions, Recommended for valid submissions, Conditional on other elements, or Optional
  • Description: A basic description
  • Value Range: Which values can appear validly in this element (case sensitive for strings)
  • Notes: Expanded description or notes on coding of values
  • Aliases: A list of currently supported Aliases (alternate element names)
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