|
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 :: 1260
|
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
|
|
|