04:05 Friday, October 23, 2020 1
Data Set Name: ae.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 ae108 Char 1 8 Reportable event since last visit
6 ae109 Char 1 9 Regularly scheduled visit
7 ae110b Char 2 10b Most recent visit code
8 ae111 Char 1 11 ER visits or hospitalized since last visit
9 ae111a Char 2 11a Number of hospitalizations
10 ae111b Char 2 11b Number of ER visits
11 ae112 Char 1 12 Any unreported serious health problems
12 ae113 Char 1 13 First or follow-up report
13 ae115a Char 1 15a Drug dispensing mixup
14 ae115b Char 1 15b Study procedure related event
15 ae115c Char 1 15c Severe allergic reaction
16 ae115d Char 1 15d Drug interactions
17 ae115e Char 1 15e Worsening of a co-morbid illness
18 ae115f Char 1 15f Pregnancy
19 ae115g Char 1 15g Other event
20 ae115gs Char 35 15g Specify other event
21 ae115gt Char 35 15g Specify other event
22 ae117a Char 1 17a Auditory/ear
23 ae117b Char 1 17b Allergy/immunologic
24 ae117c Char 1 17c Ocular/visual
25 ae117d Char 1 17d Hepatobiliary/pancreas
26 ae117e Char 1 17e Infection
27 ae117f Char 1 17f Cardiac general
28 ae117g Char 1 17g Cardiac arrhythmia
29 ae117h Char 1 17h Dermatologic/skin
30 ae117i Char 1 17i Endocrine
31 ae117j Char 1 17j Gastrointestinal
32 ae117k Char 1 17k Lymphatic
33 ae117l Char 1 17l Musculoskeletal/soft tissue
34 ae117m Char 1 17m Neurology
35 ae117n Char 1 17n Pulmonary/upper respiratory
36 ae117o Char 1 17o Renal/genitourinary
37 ae117p Char 1 17p Sexual/reproductive
04:05 Friday, October 23, 2020 2
Num Variable Type Len Label 38 ae117q Char 1 17q Blood/bone marrow
39 ae117r Char 1 17r Coagulation
40 ae117s Char 1 17s Constitutional symptoms
41 ae117t Char 1 17t Hemorrhage/bleeding
42 ae117u Char 1 17u Metabolic laboratory
43 ae117v Char 1 17v Pain
44 ae117w Char 1 17w Secondary malignancy
45 ae117x Char 1 17x Surgery/intraoperative injury
46 ae117y Char 1 17y Syndromes
47 ae117z Char 1 17z Vascular
48 ae117aa Char 1 17aa Other
49 ae117aas Char 35 17aa Specify other body system
50 ae118s Char 35 18 Short name for AE
51 ae118t Char 35 18 Short name for AE
52 ae119 Char 1 19 Severity grade
53 ae120a Char 1 20a Randomized into APRON
54 ae121 Char 1 21 Currently taking APRON study drug
55 ae122b Char 1 22b Any interruptions or restarts
56 ae123 Char 1 23 Event due to study drug
57 ae124 Char 1 24 Serious adverse event
58 ae124a Char 1 24a Required hospitalization
59 ae124b Char 1 24b Disrupt normal life functions
60 ae124c Char 1 24c Jeopardized patient's life
61 ae124d Char 1 24d Congenital anomaly or birth defect
62 ae124e Char 1 24e Death
63 ae124f Char 1 24f Life-threatening
64 ae125 Char 1 25 Unexpected adverse event
65 ae126 Char 1 26 Reason event was unexpected
66 ae127 Char 1 27 Yes for items 23, 24 and 25
67 ae128 Char 1 28 Current status of adverse event
68 formdate Num 8 4 Form date (days since enrollment)
69 ae114 Num 8 14. Date adverse event started (days since enrollment)
70 ae129 Num 8 29. Date adverse event resolved (days since enrollment)
04:05 Friday, October 23, 2020 3
Data Set Name: apron_table1.sas7bdat Num Variable Type Len Format Label
1 id Char 4 APRON Limited Use Database ID
2 tx Num 8
3 txname Char 5
4 agerzC Num 8 5.2 age at enrollment (cont)
5 agerz Num 8 age at enrollment (int)
6 female Num 8 1=female,0=male
7 hispanic Num 8 1=hispanic any,0=not
8 race3 Num 8 1=white 2=black 3=other
9 wt Num 8 D5.2
10 bmi Num 8 D5.2
11 waist Num 8 D5.1
12 dm Num 8 1. 1=dx with diabetes type 1 or type 2
13 antiemetic Num 8 (STOP) 1=current use antiemetic rx (past month)
14 rx_ppi Num 8 1=current use proton pump or gi rx (past month)
15 prokinetic Num 8 1=current use prokinetic rx (past month)
16 anxiolytic Num 8 1=current use of benzodiazepines/anxiolytic rx (past mo)
17 pain_mod Num 8 1=used neuropathic/pain modulator/anti-seizure, anti-psych, mood modulator
18 narcotic Num 8 (Caution) 1=current use narcotic > 3X/wk (past month)
19 vasb Num 8 D6.2
20 nausb Num 8 D7.3 Mean GCSI-DD nauseas severity over 7-day BL
21 vomitb Num 8 D7.3 Mean GCSI-DD vomiting severity over 7-day BL
22 earlysatb Num 8 D7.3 Mean GCSI-DD early satiety severity over 7-day BL
23 excfullb Num 8 D7.3 Mean GCSI-DD excessive fullness severity over 7-day BL
24 bloatb Num 8 D7.3 Mean GCSI-DD Bloating severity over 7-day BL
25 upabb Num 8 D7.3 Mean GCSI-DD Upper absominal pain severity over 7-day BL
26 vomitnb Num 8 D7.3 Mean daily episodes of vomiting over 7-day BL
27 retchnb Num 8 D7.3 Mean daily episodes of retching over 7-day BL
28 naushrb Num 8 D7.3 Mean daily hours of nausea over 7-day BL
29 osxb Num 8 D7.3 Mean overall severity of gp symptoms over 7-day BL
30 gcsiddb Num 8 D7.3 Mean total GCSI-DD score over 7-day BL
31 nauseasx Num 8
32 retchingsx Num 8
33 vomitsx Num 8
34 nausea_ss Num 8
35 appetite_ss Num 8
36 bloat_ss Num 8
37 gcsi Num 8
04:05 Friday, October 23, 2020 4
Num Variable Type Len Format Label 38 lowabpainsx Num 8
39 lowabdiscomfsx Num 8
40 constipatesx Num 8
41 diarrheasx Num 8
42 upab_ss Num 8
43 gerd_ss Num 8
44 predomsx_cat5 Num 8 PAGI-SYM Predom sx:0=N/V ss,1=fullnes/early sat ss,2=bloat ss,3=upab pain ss,4=constip,diarrhea,5=any other
45 gsrstot Num 8 D4.1
46 retain1 Num 8 % gastric retention at 1 hr
47 retain2 Num 8 % gastric retention at 2 hr
48 retain4 Num 8 % gastric retention at 4 hr
49 gedelay Num 8 delayed emptying at either 2 or 4 hr
50 gerapid Num 8 rapid emptying: < 30% at 1 hr
04:05 Friday, October 23, 2020 5
Data Set Name: bd.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 bd108 Char 2 8 Sum of all 21 items
6 bd109 Char 1 9 Sum > 28
7 bd110 Char 1 10 Score 2 or 3 in item 2
8 bd111 Char 1 11 Score 2 or 3 in item 9
9 formdate Num 8 4 Form date (days since enrollment)
04:05 Friday, October 23, 2020 6
Data Set Name: bh.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 bh108 Char 1 8 Gp symptoms for at least 6 months
6 bh109a Char 1 9a Diabetes type 1 or 2
7 bh109b Char 1 9b Pyloric obstruction
8 bh109c Char 1 9c Intestinal obstruction
9 bh109d Char 1 9d Advanced liver disease (CPT score >=10)
10 bh109e Char 1 9e Inflammatory bowel disease
11 bh109f Char 1 9f Thyroid disease
12 bh109g Char 1 9g Peptic ulcer disease
13 bh109h Char 1 9h Gastroesophageal reflux disease
14 bh109i Char 1 9i Interstitial cystitis
15 bh109j Char 1 9j Bladder dysfunction
16 bh109k Char 1 9k Diverticulosis
17 bh109l Char 1 9l Endometriosis
18 bh109m Char 1 9m Blood clots
19 bh109n Char 1 9n Hemophilia
20 bh109o Char 1 9o Systemic lupus erythematosus (SLE)
21 bh109p Char 1 9p Rheumatoid arthritis
22 bh109q Char 1 9q Fibromyalgia
23 bh109r Char 1 9r Scleroderma
24 bh109s Char 1 9s Malignancy
25 bh109t Char 1 9t Migraine headaches
26 bh109u Char 1 9u Hypertension
27 bh109v Char 1 9v Coronary artery disease
28 bh109w Char 1 9w Cerebrovascular disease
29 bh109x Char 1 9x Hyperlipidemia
30 bh109y Char 1 9y Myocardial infarction
31 bh109z Char 1 9z Pancreatitis
32 bh109aa Char 1 9aa Cholelithiasis
33 bh109ab Char 1 9ab Gallbladder disease
34 bh109ac Char 1 9ac Polycystic ovary syndrome
35 bh109ad Char 1 9ad Myopathy
36 bh109ae Char 1 9ae Multiple sclerosis
37 bh109af Char 1 9af Eating disorders
04:05 Friday, October 23, 2020 7
Num Variable Type Len Label 38 bh109ag Char 1 9ag Major depression
39 bh109ah Char 1 9ah Schizophrenia
40 bh109ai Char 1 9ai Bipolar disorder
41 bh109aj Char 1 9aj Obsessive compulsive disorder
42 bh109ak Char 1 9ak Severe anxiety or personality disorder
43 bh109al Char 1 9al Dyslexia or learning problems
44 bh109am Char 1 9am Other diagnosis #1
45 bh109ams Char 35 9am Specify other diagnosis
46 bh109an Char 1 9an Other diagnosis #2
47 bh109ans Char 35 9an Specify other diagnosis
48 bh109ao Char 1 9ao Other diagnosis #3
49 bh109aos Char 35 9ao Specify other diagnosis
50 bh109ap Char 1 9ap None of the above
51 bh110 Char 1 10 Any proton pump inhibitors in past month
52 bh110a Char 1 10a Antacids
53 bh110as Char 35 10a Specify antacids
54 bh110b Char 1 10b Cimetidine (Tagamet)
55 bh110c Char 1 10c Dexlansoprazole (Dexilant)
56 bh110d Char 1 10d Esomeprazole (Nexium)
57 bh110e Char 1 10e Famotidine (Pepcid)
58 bh110f Char 1 10f Lansoprazole (Prevacid)
59 bh110g Char 1 10g Nizatidine (Axid)
60 bh110h Char 1 10h Omeprazole (Prilosec)
61 bh110i Char 1 10i Pantoprazole (Protonix)
62 bh110j Char 1 10j Rabeprazole (Aciphex)
63 bh110k Char 1 10k Rantidine (Zantac)
64 bh110l Char 1 10l Other
65 bh110ls Char 35 10l Specify other
66 bh111 Char 1 11 Any benzodiazepines in past month
67 bh111a Char 1 11a Alprazolam (Xanax)
68 bh111b Char 1 11b Buspirone (BuSpar)
69 bh111c Char 1 11c Chlordiazepoxide (Librax)
70 bh111d Char 1 11d Clonazepam (Klonopin)
71 bh111e Char 1 11e Diazepam (Valium)
72 bh111f Char 1 11f Flurazepam (Dalmane)
73 bh111g Char 1 11g Lorazepam (Ativan)
74 bh111h Char 1 11h Midazolam (Versed)
75 bh111i Char 1 11i Oxazepam (Serax)
76 bh111j Char 1 11j Quazepam (Doral)
04:05 Friday, October 23, 2020 8
Num Variable Type Len Label 77 bh111k Char 1 11k Quetiapine fumarate (Seroquel)
78 bh111l Char 1 11l Temazepam (Restoril)
79 bh111m Char 1 11m Triazolam (Halcon)
80 bh111n Char 1 11n Other
81 bh111ns Char 35 11n Specify other
82 bh112 Char 1 12 Cisapride, warfarin, pimozide, ... in past month
83 bh113 Char 1 13 Any prokinetic medicines in past month
84 bh113a Char 1 13a Azithromycin (Zithromax)
85 bh113b Char 1 13b Bethanechol (Duvoid)
86 bh113c Char 1 13c Botulinum toxin (Botox)
87 bh113d Char 1 13d Clarithromycin (Biaxin)
88 bh113e Char 1 13e Domperidone (Motilium)
89 bh113f Char 1 13f Erythromycin
90 bh113g Char 1 13g Metoclopramide (Reglan)
91 bh113h Char 1 13h Other prokinetic medications
92 bh113hs Char 35 13h Specify other prokinetic medications
93 bh114 Char 1 14 Antiemetic medications in past month
94 bh114a Char 1 14a Aprepitant (Emend)
95 bh114b Char 1 14b Dolasetron (Anzemet)
96 bh114c Char 1 14c Dronabinol (Marinol)
97 bh114d Char 1 14d Granisetron (Kytril)
98 bh114e Char 1 14e Meclizine (Antivert)
99 bh114f Char 1 14f Ondansetron (Zofran)
100 bh114g Char 1 14g Palonosetron (Aloxi)
101 bh114h Char 1 14h Prochlorperazine (Compazine)
102 bh114i Char 1 14i Promethazine (Pentazine)
103 bh114j Char 1 14j Tetrahydrocannabinol (THC)
104 bh114k Char 1 14k Trimethobenzamide (Benzacot)
105 bh114l Char 1 14l Tropisetron (Navoban)
106 bh114m Char 1 14m Other antiemetic medications
107 bh114ms Char 35 14m Specify other antiemetic medications
108 bh115 Char 1 15 Any SSRIs in the past month
109 bh115a Char 1 15a Citalopram (Celexa)
110 bh115b Char 1 15b Escitalopram (Lexapro)
111 bh115c Char 1 15c Fluxetine (Prozac)
112 bh115d Char 1 15d Fluvoxamine (Luvox)
113 bh115e Char 1 15e Parozetine (Paxil)
114 bh115f Char 1 15f Sertraline (Zoloft)
115 bh115g Char 1 15g Other SSRI
04:05 Friday, October 23, 2020 9
Num Variable Type Len Label 116 bh115gs Char 35 15g Specify other SSRI
117 bh116 Char 1 16 Any tricyclic antidepressants in past month
118 bh116a Char 1 16a Amitriptyline (Elavil)
119 bh116b Char 1 16b Amoxapine (Asendin)
120 bh116c Char 1 16c Clomipramine (Anafranil)
121 bh116d Char 1 16d Desipramine (Norpramin)
122 bh116e Char 1 16e Doxein (Sinequan)
123 bh116f Char 1 16f Imipramine (Tofranil)
124 bh116g Char 1 16g Nortriptyline (Pamelor)
125 bh116h Char 1 16h Trimipramin (Surmontil)
126 bh116i Char 1 16i Protriptyline (Pliva, Vivactil)
127 bh116j Char 1 16j Other tricyclic antidepressants
128 bh116js Char 35 16j Specify other tricyclic antidepressants
129 bh117 Char 1 17 Narcotic pain medication in past month
130 bh117a Char 1 17a Buprenorphine
131 bh117b Char 1 17b Butalbital combination
132 bh117c Char 1 17c Codeine combinations
133 bh117d Char 1 17d Fentanyl
134 bh117e Char 1 17e Fentanyl patch
135 bh117f Char 1 17f Hydrocodone combinations
136 bh117g Char 1 17g Hydromorphone
137 bh117h Char 1 17h Methadone
138 bh117i Char 1 17i Morphine sulfate
139 bh117j Char 1 17j Oxycodone combinations
140 bh117k Char 1 17k Pentazocine
141 bh117l Char 1 17l Propoxyphene combinations
142 bh117m Char 1 17m Tapentadol
143 bh117n Char 1 17n Tramadol
144 bh117o Char 1 17o Other narcotic pain medications
145 bh117os Char 35 17o Specify narcotic pain medications
146 bh118 Char 1 18 Other medications in past month
147 bh118a Char 1 18a Aripiprazole (Abilify)
148 bh118b Char 1 18b Brupropion (Wellbutrin)
149 bh118c Char 1 18c Divalproex sodium (Depakote)
150 bh118d Char 1 18d Duloxetine (Cymbalta)
151 bh118e Char 1 18e Gabapentin (Neurontin)
152 bh118f Char 1 18f Haloperidol (Haldol)
153 bh118g Char 1 18g Lamotrigine (Lamictal)
154 bh118h Char 1 18h Maprotiline (Ludiomil)
04:05 Friday, October 23, 2020 10
Num Variable Type Len Label 155 bh118i Char 1 18i Mirtazipine (Remeron)
156 bh118j Char 1 18j Olanzapine (Zyprexa)
157 bh118k Char 1 18k Pregabalin (Lyrica)
158 bh118l Char 1 18l Venlafaxine (Effexor)
159 bh118m Char 1 18m Ziprasidone (Geodon)
160 bh118n Char 1 18n Other medication
161 bh118ns Char 35 18n Specify other medication
162 bh118o Char 1 18o Other medication
163 bh118os Char 35 18o Specify other medication
164 bh118p Char 1 18p Other medication
165 bh118ps Char 35 18p Specify other medication
166 bh119 Char 1 19 Hypersensitivity to aprepitant
167 bh120 Char 1 20 CGPI
168 formdate Num 8 4 Form date (days since enrollment)
04:05 Friday, October 23, 2020 11
Data Set Name: dd1.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 dd108 Char 2 8 Number of diaries completed
6 dd109 Char 3 9 Calibration line length
7 dd110 Char 1 10 Additional diaries
8 dd113 Char 3 13 Nausea score - day 1
9 dd113a Char 1 13a Nausea in past 24 hours - day 1
10 dd113b Char 1 13b Vomiting in past 24 hours - day 1
11 dd113c Char 1 13c Unable to finish meal in past 24 hours - day 1
12 dd113d Char 1 13d Feel excess. full in past 24 hours - day 1
13 dd113e Char 1 13e Bloating in past 24 hours - day 1
14 dd113f Char 1 13f Upper abdominal pain in past 24 hours - day 1
15 dd113g Char 2 13g Episodes of vomiting in past 24 hours - day 1
16 dd113h Char 2 13h Episodes of retching in past 24 hours - day 1
17 dd113i Char 2 13i Hours of nausea in past 24 hours - day 1
18 dd113j Char 1 13j Overall severity of GP sx in past 24 hours - day 1
19 dd113k Char 1 13k Form completion - day 1
20 dd113l Char 1 13l Took study drug today - day 1
21 dd114 Char 3 14 Nausea score - day 2
22 dd114a Char 1 14a Nausea in past 24 hours - day 2
23 dd114b Char 1 14b Vomiting in past 24 hours - day 2
24 dd114c Char 1 14c Unable to finish meal in past 24 hours - day 2
25 dd114d Char 1 14d Feel excess. full in past 24 hours - day 2
26 dd114e Char 1 14e Bloating in past 24 hours - day 2
27 dd114f Char 1 14f Upper abdominal pain in past 24 hours - day 2
28 dd114g Char 2 14g Episodes of vomiting in past 24 hours - day 2
29 dd114h Char 2 14h Episodes of retching in past 24 hours - day 2
30 dd114i Char 2 14i Hours of nausea in past 24 hours - day 2
31 dd114j Char 1 14j Overall severity of GP sx in past 24 hours - day 2
32 dd114k Char 1 14k Form completion - day 2
33 dd114l Char 1 14l Took study drug today - day 2
34 dd115 Char 3 15 Nausea score - day 3
35 dd115a Char 1 15a Nausea in past 24 hours - day 3
36 dd115b Char 1 15b Vomiting in past 24 hours - day 3
37 dd115c Char 1 15c Unable to finish meal in past 24 hours - day 3
04:05 Friday, October 23, 2020 12
Num Variable Type Len Label 38 dd115d Char 1 15d Feel excess. full in past 24 hours - day 3
39 dd115e Char 1 15e Bloating in past 24 hours - day 3
40 dd115f Char 1 15f Upper abdominal pain in past 24 hours - day 3
41 dd115g Char 2 15g Episodes of vomiting in past 24 hours - day 3
42 dd115h Char 2 15h Episodes of retching in past 24 hours - day 3
43 dd115i Char 2 15i Hours of nausea in past 24 hours - day 3
44 dd115j Char 1 15j Overall severity of GP sx in past 24 hours - day 3
45 dd115k Char 1 15k Form completion - day 3
46 dd115l Char 1 15l Took study drug today - day 3
47 dd116 Char 3 16 Nausea score - day 4
48 dd116a Char 1 16a Nausea in past 24 hours - day 4
49 dd116b Char 1 16b Vomiting in past 24 hours - day 4
50 dd116c Char 1 16c Unable to finish meal in past 24 hours - day 4
51 dd116d Char 1 16d Feel excess. full in past 24 hours - day 4
52 dd116e Char 1 16e Bloating in past 24 hours - day 4
53 dd116f Char 1 16f Upper abdominal pain in past 24 hours - day 4
54 dd116g Char 2 16g Episodes of vomiting in past 24 hours - day 4
55 dd116h Char 2 16h Episodes of retching in past 24 hours - day 4
56 dd116i Char 2 16i Hours of nausea in past 24 hours - day 4
57 dd116j Char 1 16j Overall severity of GP sx in past 24 hours - day 4
58 dd116k Char 1 16k Form completion - day 4
59 dd116l Char 1 16l Took study drug today - day 4
60 dd117 Char 3 17 Nausea score - day 5
61 dd117a Char 1 17a Nausea in past 24 hours - day 5
62 dd117b Char 1 17b Vomiting in past 24 hours - day 5
63 dd117c Char 1 17c Unable to finish meal in past 24 hours - day 5
64 dd117d Char 1 17d Feel excess. full in past 24 hours - day 5
65 dd117e Char 1 17e Bloating in past 24 hours - day 5
66 dd117f Char 1 17f Upper abdominal pain in past 24 hours - day 5
67 dd117g Char 2 17g Episodes of vomiting in past 24 hours - day 5
68 dd117h Char 2 17h Episodes of retching in past 24 hours - day 5
69 dd117i Char 2 17i Hours of nausea in past 24 hours - day 5
70 dd117j Char 1 17j Overall severity of GP sx in past 24 hours - day 5
71 dd117k Char 1 17k Form completion - day 5
72 dd117l Char 1 17l Took study drug today - day 5
73 dd118 Char 3 18 Nausea score - day 6
74 dd118a Char 1 18a Nausea in past 24 hours - day 6
75 dd118b Char 1 18b Vomiting in past 24 hours - day 6
76 dd118c Char 1 18c Unable to finish meal in past 24 hours - day 6
04:05 Friday, October 23, 2020 13
Num Variable Type Len Label 77 dd118d Char 1 18d Feel excess. full in past 24 hours - day 6
78 dd118e Char 1 18e Bloating in past 24 hours - day 6
79 dd118f Char 1 18f Upper abdominal pain in past 24 hours - day 6
80 dd118g Char 2 18g Episodes of vomiting in past 24 hours - day 6
81 dd118h Char 2 18h Episodes of retching in past 24 hours - day 6
82 dd118i Char 2 18i Hours of nausea in past 24 hours - day 6
83 dd118j Char 1 18j Overall severity of GP sx in past 24 hours - day 6
84 dd118k Char 1 18k Form completion - day 6
85 dd118l Char 1 18l Took study drug today - day 6
86 dd119 Char 3 19 Nausea score - day 7
87 dd119a Char 1 19a Nausea in past 24 hours - day 7
88 dd119b Char 1 19b Vomiting in past 24 hours - day 7
89 dd119c Char 1 19c Unable to finish meal in past 24 hours - day 7
90 dd119d Char 1 19d Feel excess. full in past 24 hours - day 7
91 dd119e Char 1 19e Bloating in past 24 hours - day 7
92 dd119f Char 1 19f Upper abdominal pain in past 24 hours - day 7
93 dd119g Char 2 19g Episodes of vomiting in past 24 hours - day 7
94 dd119h Char 2 19h Episodes of retching in past 24 hours - day 7
95 dd119i Char 2 19i Hours of nausea in past 24 hours - day 7
96 dd119j Char 1 19j Overall severity of GP sx in past 24 hours - day 7
97 dd119k Char 1 19k Form completion - day 7
98 dd119l Char 1 19l Took study drug today - day 7
99 dd120 Char 3 20 Nausea score - day 8
100 dd120a Char 1 20a Nausea in past 24 hours - day 8
101 dd120b Char 1 20b Vomiting in past 24 hours - day 8
102 dd120c Char 1 20c Unable to finish meal in past 24 hours - day 8
103 dd120d Char 1 20d Feel excess. full in past 24 hours - day 8
104 dd120e Char 1 20e Bloating in past 24 hours - day 8
105 dd120f Char 1 20f Upper abdominal pain in past 24 hours - day 8
106 dd120g Char 2 20g Episodes of vomiting in past 24 hours - day 8
107 dd120h Char 2 20h Episodes of retching in past 24 hours - day 8
108 dd120i Char 2 20i Hours of nausea in past 24 hours - day 8
109 dd120j Char 1 20j Overall severity of GP sx in past 24 hours - day 8
110 dd120k Char 1 20k Form completion - day 8
111 dd120l Char 1 20l Took study drug today - day 8
112 dd121 Char 3 21 Nausea score - day 9
113 dd121a Char 1 21a Nausea in past 24 hours - day 9
114 dd121b Char 1 21b Vomiting in past 24 hours - day 9
115 dd121c Char 1 21c Unable to finish meal in past 24 hours - day 9
04:05 Friday, October 23, 2020 14
Num Variable Type Len Label 116 dd121d Char 1 21d Feel excess. full in past 24 hours - day 9
117 dd121e Char 1 21e Bloating in past 24 hours - day 9
118 dd121f Char 1 21f Upper abdominal pain in past 24 hours - day 9
119 dd121g Char 2 21g Episodes of vomiting in past 24 hours - day 9
120 dd121h Char 2 21h Episodes of retching in past 24 hours - day 9
121 dd121i Char 2 21i Hours of nausea in past 24 hours - day 9
122 dd121j Char 1 21j Overall severity of GP sx in past 24 hours - day 9
123 dd121k Char 1 21k Form completion - day 9
124 dd121l Char 1 21l Took study drug today - day 9
125 dd122 Char 3 22 Nausea score - day 10
126 dd122a Char 1 22a Nausea in past 24 hours - day 10
127 dd122b Char 1 22b Vomiting in past 24 hours - day 10
128 dd122c Char 1 22c Unable to finish meal in past 24 hours - day 10
129 dd122d Char 1 22d Feel excess. full in past 24 hours - day 10
130 dd122e Char 1 22e Bloating in past 24 hours - day 10
131 dd122f Char 1 22f Upper abdominal pain in past 24 hours - day 10
132 dd122g Char 2 22g Episodes of vomiting in past 24 hours - day 10
133 dd122h Char 2 22h Episodes of retching in past 24 hours - day 10
134 dd122i Char 2 22i Hours of nausea in past 24 hours - day 10
135 dd122j Char 1 22j Overall severity of GP sx in past 24 hours - day 10
136 dd122k Char 1 22k Form completion - day 10
137 dd122l Char 1 22l Took study drug today - day 10
138 dd123 Char 3 23 Nausea score - day 11
139 dd123a Char 1 23a Nausea in past 24 hours - day 11
140 dd123b Char 1 23b Vomiting in past 24 hours - day 11
141 dd123c Char 1 23c Unable to finish meal in past 24 hours - day 11
142 dd123d Char 1 23d Feel excess. full in past 24 hours - day 11
143 dd123e Char 1 23e Bloating in past 24 hours - day 11
144 dd123f Char 1 23f Upper abdominal pain in past 24 hours - day 11
145 dd123g Char 2 23g Episodes of vomiting in past 24 hours - day 11
146 dd123h Char 2 23h Episodes of retching in past 24 hours - day 11
147 dd123i Char 2 23i Hours of nausea in past 24 hours - day 11
148 dd123j Char 1 23j Overall severity of GP sx in past 24 hours - day 11
149 dd123k Char 1 23k Form completion - day 11
150 dd123l Char 1 23l Took study drug today - day 11
151 dd124 Char 3 24 Nausea score - day 12
152 dd124a Char 1 24a Nausea in past 24 hours - day 12
153 dd124b Char 1 24b Vomiting in past 24 hours - day 12
154 dd124c Char 1 24c Unable to finish meal in past 24 hours - day 12
04:05 Friday, October 23, 2020 15
Num Variable Type Len Label 155 dd124d Char 1 24d Feel excess. full in past 24 hours - day 12
156 dd124e Char 1 24e Bloating in past 24 hours - day 12
157 dd124f Char 1 24f Upper abdominal pain in past 24 hours - day 12
158 dd124g Char 2 24g Episodes of vomiting in past 24 hours - day 12
159 dd124h Char 2 24h Episodes of retching in past 24 hours - day 12
160 dd124i Char 2 24i Hours of nausea in past 24 hours - day 12
161 dd124j Char 1 24j Overall severity of GP sx in past 24 hours - day 12
162 dd124k Char 1 24k Form completion - day 12
163 dd124l Char 1 24l Took study drug today - day 12
164 dd125 Char 3 25 Nausea score - day 13
165 dd125a Char 1 25a Nausea in past 24 hours - day 13
166 dd125b Char 1 25b Vomiting in past 24 hours - day 13
167 dd125c Char 1 25c Unable to finish meal in past 24 hours - day 13
168 dd125d Char 1 25d Feel excess. full in past 24 hours - day 13
169 dd125e Char 1 25e Bloating in past 24 hours - day 13
170 dd125f Char 1 25f Upper abdominal pain in past 24 hours - day 13
171 dd125g Char 2 25g Episodes of vomiting in past 24 hours - day 13
172 dd125h Char 2 25h Episodes of retching in past 24 hours - day 13
173 dd125i Char 2 25i Hours of nausea in past 24 hours - day 13
174 dd125j Char 1 25j Overall severity of GP sx in past 24 hours - day 13
175 dd125k Char 1 25k Form completion - day 13
176 dd125l Char 1 25l Took study drug today - day 13
177 dd126 Char 3 26 Nausea score - day 14
178 dd126a Char 1 26a Nausea in past 24 hours - day 14
179 dd126b Char 1 26b Vomiting in past 24 hours - day 14
180 dd126c Char 1 26c Unable to finish meal in past 24 hours - day 14
181 dd126d Char 1 26d Feel excess. full in past 24 hours - day 14
182 dd126e Char 1 26e Bloating in past 24 hours - day 14
183 dd126f Char 1 26f Upper abdominal pain in past 24 hours - day 14
184 dd126g Char 2 26g Episodes of vomiting in past 24 hours - day 14
185 dd126h Char 2 26h Episodes of retching in past 24 hours - day 14
186 dd126i Char 2 26i Hours of nausea in past 24 hours - day 14
187 dd126j Char 1 26j Overall severity of GP sx in past 24 hours - day 14
188 dd126k Char 1 26k Form completion - day 14
189 dd126l Char 1 26l Took study drug today - day 14
190 formdate Num 8 4 Form date (days since enrollment)
04:05 Friday, October 23, 2020 16
Data Set Name: dd2.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 dd208 Char 2 8 Number of diaries completed
6 dd209 Char 3 9 Calibration line length
7 dd213 Char 3 13 Nausea score - day 1
8 dd213a Char 1 13a Nausea in past 24 hours - day 1
9 dd213b Char 1 13b Vomiting in past 24 hours - day 1
10 dd213c Char 1 13c Unable to finish meal in past 24 hours - day 1
11 dd213d Char 1 13d Feel excess. full in past 24 hours - day 1
12 dd213e Char 1 13e Bloating in past 24 hours - day 1
13 dd213f Char 1 13f Upper abdominal pain in past 24 hours - day 1
14 dd213g Char 2 13g Episodes of vomiting in past 24 hours - day 1
15 dd213h Char 2 13h Episodes of retching in past 24 hours - day 1
16 dd213i Char 2 13i Hours of nausea in past 24 hours - day 1
17 dd213j Char 1 13j Overall severity of GP sx in past 24 hours - day 1
18 dd213k Char 1 13k Form completion - day 1
19 dd213ks Char 35 13k Specify other time form completed - day 1
20 dd213l Char 1 13l Took study drug today - day 1
21 dd214 Char 3 14 Nausea score - day 2
22 dd214a Char 1 14a Nausea in past 24 hours - day 2
23 dd214b Char 1 14b Vomiting in past 24 hours - day 2
24 dd214c Char 1 14c Unable to finish meal in past 24 hours - day 2
25 dd214d Char 1 14d Feel excess. full in past 24 hours - day 2
26 dd214e Char 1 14e Bloating in past 24 hours - day 2
27 dd214f Char 1 14f Upper abdominal pain in past 24 hours - day 2
28 dd214g Char 2 14g Episodes of vomiting in past 24 hours - day 2
29 dd214h Char 2 14h Episodes of retching in past 24 hours - day 2
30 dd214i Char 2 14i Hours of nausea in past 24 hours - day 2
31 dd214j Char 1 14j Overall severity of GP sx in past 24 hours - day 2
32 dd214k Char 1 14k Form completion - day 2
33 dd214ks Char 35 14k Specify other time form completed - day 2
34 dd214l Char 1 14l Took study drug today - day 2
35 dd215 Char 3 15 Nausea score - day 3
36 dd215a Char 1 15a Nausea in past 24 hours - day 3
37 dd215b Char 1 15b Vomiting in past 24 hours - day 3
04:05 Friday, October 23, 2020 17
Num Variable Type Len Label 38 dd215c Char 1 15c Unable to finish meal in past 24 hours - day 3
39 dd215d Char 1 15d Feel excess. full in past 24 hours - day 3
40 dd215e Char 1 15e Bloating in past 24 hours - day 3
41 dd215f Char 1 15f Upper abdominal pain in past 24 hours - day 3
42 dd215g Char 2 15g Episodes of vomiting in past 24 hours - day 3
43 dd215h Char 2 15h Episodes of retching in past 24 hours - day 3
44 dd215i Char 2 15i Hours of nausea in past 24 hours - day 3
45 dd215j Char 1 15j Overall severity of GP sx in past 24 hours - day 3
46 dd215k Char 1 15k Form completion - day 3
47 dd215ks Char 35 15k Specify other time form completed - day 3
48 dd215l Char 1 15l Took study drug today - day 3
49 dd216 Char 3 16 Nausea score - day 4
50 dd216a Char 1 16a Nausea in past 24 hours - day 4
51 dd216b Char 1 16b Vomiting in past 24 hours - day 4
52 dd216c Char 1 16c Unable to finish meal in past 24 hours - day 4
53 dd216d Char 1 16d Feel excess. full in past 24 hours - day 4
54 dd216e Char 1 16e Bloating in past 24 hours - day 4
55 dd216f Char 1 16f Upper abdominal pain in past 24 hours - day 4
56 dd216g Char 2 16g Episodes of vomiting in past 24 hours - day 4
57 dd216h Char 2 16h Episodes of retching in past 24 hours - day 4
58 dd216i Char 2 16i Hours of nausea in past 24 hours - day 4
59 dd216j Char 1 16j Overall severity of GP sx in past 24 hours - day 4
60 dd216k Char 1 16k Form completion - day 4
61 dd216ks Char 35 16k Specify other time form completed - day 4
62 dd216l Char 1 16l Took study drug today - day 4
63 dd217 Char 3 17 Nausea score - day 5
64 dd217a Char 1 17a Nausea in past 24 hours - day 5
65 dd217b Char 1 17b Vomiting in past 24 hours - day 5
66 dd217c Char 1 17c Unable to finish meal in past 24 hours - day 5
67 dd217d Char 1 17d Feel excess. full in past 24 hours - day 5
68 dd217e Char 1 17e Bloating in past 24 hours - day 5
69 dd217f Char 1 17f Upper abdominal pain in past 24 hours - day 5
70 dd217g Char 2 17g Episodes of vomiting in past 24 hours - day 5
71 dd217h Char 2 17h Episodes of retching in past 24 hours - day 5
72 dd217i Char 2 17i Hours of nausea in past 24 hours - day 5
73 dd217j Char 1 17j Overall severity of GP sx in past 24 hours - day 5
74 dd217k Char 1 17k Form completion - day 5
75 dd217ks Char 35 17k Specify other time form completed - day 5
76 dd217l Char 1 17l Took study drug today - day 5
04:05 Friday, October 23, 2020 18
Num Variable Type Len Label 77 dd218 Char 3 18 Nausea score - day 6
78 dd218a Char 1 18a Nausea in past 24 hours - day 6
79 dd218b Char 1 18b Vomiting in past 24 hours - day 6
80 dd218c Char 1 18c Unable to finish meal in past 24 hours - day 6
81 dd218d Char 1 18d Feel excess. full in past 24 hours - day 6
82 dd218e Char 1 18e Bloating in past 24 hours - day 6
83 dd218f Char 1 18f Upper abdominal pain in past 24 hours - day 6
84 dd218g Char 2 18g Episodes of vomiting in past 24 hours - day 6
85 dd218h Char 2 18h Episodes of retching in past 24 hours - day 6
86 dd218i Char 2 18i Hours of nausea in past 24 hours - day 6
87 dd218j Char 1 18j Overall severity of GP sx in past 24 hours - day 6
88 dd218k Char 1 18k Form completion - day 6
89 dd218ks Char 35 18k Specify other time form completed - day 6
90 dd218l Char 1 18l Took study drug today - day 6
91 dd219 Char 3 19 Nausea score - day 7
92 dd219a Char 1 19a Nausea in past 24 hours - day 7
93 dd219b Char 1 19b Vomiting in past 24 hours - day 7
94 dd219c Char 1 19c Unable to finish meal in past 24 hours - day 7
95 dd219d Char 1 19d Feel excess. full in past 24 hours - day 7
96 dd219e Char 1 19e Bloating in past 24 hours - day 7
97 dd219f Char 1 19f Upper abdominal pain in past 24 hours - day 7
98 dd219g Char 2 19g Episodes of vomiting in past 24 hours - day 7
99 dd219h Char 2 19h Episodes of retching in past 24 hours - day 7
100 dd219i Char 2 19i Hours of nausea in past 24 hours - day 7
101 dd219j Char 1 19j Overall severity of GP sx in past 24 hours - day 7
102 dd219k Char 1 19k Form completion - day 7
103 dd219ks Char 35 19k Specify other time form completed - day 7
104 dd219l Char 1 19l Took study drug today - day 7
105 dd220 Char 3 20 Nausea score - day 8
106 dd220a Char 1 20a Nausea in past 24 hours - day 8
107 dd220b Char 1 20b Vomiting in past 24 hours - day 8
108 dd220c Char 1 20c Unable to finish meal in past 24 hours - day 8
109 dd220d Char 1 20d Feel excess. full in past 24 hours - day 8
110 dd220e Char 1 20e Bloating in past 24 hours - day 8
111 dd220f Char 1 20f Upper abdominal pain in past 24 hours - day 8
112 dd220g Char 2 20g Episodes of vomiting in past 24 hours - day 8
113 dd220h Char 2 20h Episodes of retching in past 24 hours - day 8
114 dd220i Char 2 20i Hours of nausea in past 24 hours - day 8
115 dd220j Char 1 20j Overall severity of GP sx in past 24 hours - day 8
04:05 Friday, October 23, 2020 19
Num Variable Type Len Label 116 dd220k Char 1 20k Form completion - day 8
117 dd220ks Char 35 20k Specify other time form completed - day 8
118 dd220l Char 1 20l Took study drug today - day 8
119 dd221 Char 3 21 Nausea score - day 9
120 dd221a Char 1 21a Nausea in past 24 hours - day 9
121 dd221b Char 1 21b Vomiting in past 24 hours - day 9
122 dd221c Char 1 21c Unable to finish meal in past 24 hours - day 9
123 dd221d Char 1 21d Feel excess. full in past 24 hours - day 9
124 dd221e Char 1 21e Bloating in past 24 hours - day 9
125 dd221f Char 1 21f Upper abdominal pain in past 24 hours - day 9
126 dd221g Char 2 21g Episodes of vomiting in past 24 hours - day 9
127 dd221h Char 2 21h Episodes of retching in past 24 hours - day 9
128 dd221i Char 2 21i Hours of nausea in past 24 hours - day 9
129 dd221j Char 1 21j Overall severity of GP sx in past 24 hours - day 9
130 dd221k Char 1 21k Form completion - day 9
131 dd221ks Char 35 21k Specify other time form completed - day 9
132 dd221l Char 1 21l Took study drug today - day 9
133 dd222 Char 3 22 Nausea score - day 10
134 dd222a Char 1 22a Nausea in past 24 hours - day 10
135 dd222b Char 1 22b Vomiting in past 24 hours - day 10
136 dd222c Char 1 22c Unable to finish meal in past 24 hours - day 10
137 dd222d Char 1 22d Feel excess. full in past 24 hours - day 10
138 dd222e Char 1 22e Bloating in past 24 hours - day 10
139 dd222f Char 1 22f Upper abdominal pain in past 24 hours - day 10
140 dd222g Char 2 22g Episodes of vomiting in past 24 hours - day 10
141 dd222h Char 2 22h Episodes of retching in past 24 hours - day 10
142 dd222i Char 2 22i Hours of nausea in past 24 hours - day 10
143 dd222j Char 1 22j Overall severity of GP sx in past 24 hours - day 10
144 dd222k Char 1 22k Form completion - day 10
145 dd222ks Char 35 22k Specify other time form completed - day 10
146 dd222l Char 1 22l Took study drug today - day 10
147 dd223 Char 3 23 Nausea score - day 11
148 dd223a Char 1 23a Nausea in past 24 hours - day 11
149 dd223b Char 1 23b Vomiting in past 24 hours - day 11
150 dd223c Char 1 23c Unable to finish meal in past 24 hours - day 11
151 dd223d Char 1 23d Feel excess. full in past 24 hours - day 11
152 dd223e Char 1 23e Bloating in past 24 hours - day 11
153 dd223f Char 1 23f Upper abdominal pain in past 24 hours - day 11
154 dd223g Char 2 23g Episodes of vomiting in past 24 hours - day 11
04:05 Friday, October 23, 2020 20
Num Variable Type Len Label 155 dd223h Char 2 23h Episodes of retching in past 24 hours - day 11
156 dd223i Char 2 23i Hours of nausea in past 24 hours - day 11
157 dd223j Char 1 23j Overall severity of GP sx in past 24 hours - day 11
158 dd223k Char 1 23k Form completion - day 11
159 dd223ks Char 35 23k Specify other time form completed - day 11
160 dd223l Char 1 23l Took study drug today - day 11
161 dd224 Char 3 24 Nausea score - day 12
162 dd224a Char 1 24a Nausea in past 24 hours - day 12
163 dd224b Char 1 24b Vomiting in past 24 hours - day 12
164 dd224c Char 1 24c Unable to finish meal in past 24 hours - day 12
165 dd224d Char 1 24d Feel excess. full in past 24 hours - day 12
166 dd224e Char 1 24e Bloating in past 24 hours - day 12
167 dd224f Char 1 24f Upper abdominal pain in past 24 hours - day 12
168 dd224g Char 2 24g Episodes of vomiting in past 24 hours - day 12
169 dd224h Char 2 24h Episodes of retching in past 24 hours - day 12
170 dd224i Char 2 24i Hours of nausea in past 24 hours - day 12
171 dd224j Char 1 24j Overall severity of GP sx in past 24 hours - day 12
172 dd224k Char 1 24k Form completion - day 12
173 dd224ks Char 35 24k Specify other time form completed - day 12
174 dd224l Char 1 24l Took study drug today - day 12
175 dd225 Char 3 25 Nausea score - day 13
176 dd225a Char 1 25a Nausea in past 24 hours - day 13
177 dd225b Char 1 25b Vomiting in past 24 hours - day 13
178 dd225c Char 1 25c Unable to finish meal in past 24 hours - day 13
179 dd225d Char 1 25d Feel excess. full in past 24 hours - day 13
180 dd225e Char 1 25e Bloating in past 24 hours - day 13
181 dd225f Char 1 25f Upper abdominal pain in past 24 hours - day 13
182 dd225g Char 2 25g Episodes of vomiting in past 24 hours - day 13
183 dd225h Char 2 25h Episodes of retching in past 24 hours - day 13
184 dd225i Char 2 25i Hours of nausea in past 24 hours - day 13
185 dd225j Char 1 25j Overall severity of GP sx in past 24 hours - day 13
186 dd225k Char 1 25k Form completion - day 13
187 dd225ks Char 35 25k Specify other time form completed - day 13
188 dd225l Char 1 25l Took study drug today - day 13
189 dd226 Char 3 26 Nausea score - day 14
190 dd226a Char 1 26a Nausea in past 24 hours - day 14
191 dd226b Char 1 26b Vomiting in past 24 hours - day 14
192 dd226c Char 1 26c Unable to finish meal in past 24 hours - day 14
193 dd226d Char 1 26d Feel excess. full in past 24 hours - day 14
04:05 Friday, October 23, 2020 21
Num Variable Type Len Label 194 dd226e Char 1 26e Bloating in past 24 hours - day 14
195 dd226f Char 1 26f Upper abdominal pain in past 24 hours - day 14
196 dd226g Char 2 26g Episodes of vomiting in past 24 hours - day 14
197 dd226h Char 2 26h Episodes of retching in past 24 hours - day 14
198 dd226i Char 2 26i Hours of nausea in past 24 hours - day 14
199 dd226j Char 1 26j Overall severity of GP sx in past 24 hours - day 14
200 dd226k Char 1 26k Form completion - day 14
201 dd226ks Char 35 26k Specify other time form completed - day 14
202 dd226l Char 1 26l Took study drug today - day 14
203 dd227 Char 3 27 Nausea score - day 15
204 dd227a Char 1 27a Nausea in past 24 hours - day 15
205 dd227b Char 1 27b Vomiting in past 24 hours - day 15
206 dd227c Char 1 27c Unable to finish meal in past 24 hours - day 15
207 dd227d Char 1 27d Feel excess. full in past 24 hours - day 15
208 dd227e Char 1 27e Bloating in past 24 hours - day 15
209 dd227f Char 1 27f Upper abdominal pain in past 24 hours - day 15
210 dd227g Char 2 27g Episodes of vomiting in past 24 hours - day 15
211 dd227h Char 2 27h Episodes of retching in past 24 hours - day 15
212 dd227i Char 2 27i Hours of nausea in past 24 hours - day 15
213 dd227j Char 1 27j Overall severity of GP sx in past 24 hours - day 15
214 dd227k Char 1 27k Form completion - day 15
215 dd227ks Char 35 27k Specify other time form completed - day 15
216 dd227l Char 1 27l Took study drug today - day 15
217 dd228 Char 3 28 Nausea score - day 16
218 dd228a Char 1 28a Nausea in past 24 hours - day 16
219 dd228b Char 1 28b Vomiting in past 24 hours - day 16
220 dd228c Char 1 28c Unable to finish meal in past 24 hours - day 16
221 dd228d Char 1 28d Feel excess. full in past 24 hours - day 16
222 dd228e Char 1 28e Bloating in past 24 hours - day 16
223 dd228f Char 1 28f Upper abdominal pain in past 24 hours - day 16
224 dd228g Char 2 28g Episodes of vomiting in past 24 hours - day 16
225 dd228h Char 2 28h Episodes of retching in past 24 hours - day 16
226 dd228i Char 2 28i Hours of nausea in past 24 hours - day 16
227 dd228j Char 1 28j Overall severity of GP sx in past 24 hours - day 16
228 dd228k Char 1 28k Form completion - day 16
229 dd228ks Char 35 28k Specify other time form completed - day 16
230 dd228l Char 1 28l Took study drug today - day 16
231 dd229 Char 3 29 Nausea score - day 17
232 dd229a Char 1 29a Nausea in past 24 hours - day 17
04:05 Friday, October 23, 2020 22
Num Variable Type Len Label 233 dd229b Char 1 29b Vomiting in past 24 hours - day 17
234 dd229c Char 1 29c Unable to finish meal in past 24 hours - day 17
235 dd229d Char 1 29d Feel excess. full in past 24 hours - day 17
236 dd229e Char 1 29e Bloating in past 24 hours - day 17
237 dd229f Char 1 29f Upper abdominal pain in past 24 hours - day 17
238 dd229g Char 2 29g Episodes of vomiting in past 24 hours - day 17
239 dd229h Char 2 29h Episodes of retching in past 24 hours - day 17
240 dd229i Char 2 29i Hours of nausea in past 24 hours - day 17
241 dd229j Char 1 29j Overall severity of GP sx in past 24 hours - day 17
242 dd229k Char 1 29k Form completion - day 17
243 dd229ks Char 35 29k Specify other time form completed - day 17
244 dd229l Char 1 29l Took study drug today - day 17
245 dd230 Char 3 30 Nausea score - day 18
246 dd230a Char 1 30a Nausea in past 24 hours - day 18
247 dd230b Char 1 30b Vomiting in past 24 hours - day 18
248 dd230c Char 1 30c Unable to finish meal in past 24 hours - day 18
249 dd230d Char 1 30d Feel excess. full in past 24 hours - day 18
250 dd230e Char 1 30e Bloating in past 24 hours - day 18
251 dd230f Char 1 30f Upper abdominal pain in past 24 hours - day 18
252 dd230g Char 2 30g Episodes of vomiting in past 24 hours - day 18
253 dd230h Char 2 30h Episodes of retching in past 24 hours - day 18
254 dd230i Char 2 30i Hours of nausea in past 24 hours - day 18
255 dd230j Char 1 30j Overall severity of GP sx in past 24 hours - day 18
256 dd230k Char 1 30k Form completion - day 18
257 dd230ks Char 35 30k Specify other time form completed - day 18
258 dd230l Char 1 30l Took study drug today - day 18
259 dd231 Char 3 31 Nausea score - day 19
260 dd231a Char 1 31a Nausea in past 24 hours - day 19
261 dd231b Char 1 31b Vomiting in past 24 hours - day 19
262 dd231c Char 1 31c Unable to finish meal in past 24 hours - day 19
263 dd231d Char 1 31d Feel excess. full in past 24 hours - day 19
264 dd231e Char 1 31e Bloating in past 24 hours - day 19
265 dd231f Char 1 31f Upper abdominal pain in past 24 hours - day 19
266 dd231g Char 2 31g Episodes of vomiting in past 24 hours - day 19
267 dd231h Char 2 31h Episodes of retching in past 24 hours - day 19
268 dd231i Char 2 31i Hours of nausea in past 24 hours - day 19
269 dd231j Char 1 31j Overall severity of GP sx in past 24 hours - day 19
270 dd231k Char 1 31k Form completion - day 19
271 dd231ks Char 35 31k Specify other time form completed - day 19
04:05 Friday, October 23, 2020 23
Num Variable Type Len Label 272 dd231l Char 1 31l Took study drug today - day 19
273 dd232 Char 3 32 Nausea score - day 20
274 dd232a Char 1 32a Nausea in past 24 hours - day 20
275 dd232b Char 1 32b Vomiting in past 24 hours - day 20
276 dd232c Char 1 32c Unable to finish meal in past 24 hours - day 20
277 dd232d Char 1 32d Feel excess. full in past 24 hours - day 20
278 dd232e Char 1 32e Bloating in past 24 hours - day 20
279 dd232f Char 1 32f Upper abdominal pain in past 24 hours - day 20
280 dd232g Char 2 32g Episodes of vomiting in past 24 hours - day 20
281 dd232h Char 2 32h Episodes of retching in past 24 hours - day 20
282 dd232i Char 2 32i Hours of nausea in past 24 hours - day 20
283 dd232j Char 1 32j Overall severity of GP sx in past 24 hours - day 20
284 dd232k Char 1 32k Form completion - day 20
285 dd232ks Char 35 32k Specify other time form completed - day 20
286 dd232l Char 1 32l Took study drug today - day 20
287 dd233 Char 3 33 Nausea score - day 21
288 dd233a Char 1 33a Nausea in past 24 hours - day 21
289 dd233b Char 1 33b Vomiting in past 24 hours - day 21
290 dd233c Char 1 33c Unable to finish meal in past 24 hours - day 21
291 dd233d Char 1 33d Feel excess. full in past 24 hours - day 21
292 dd233e Char 1 33e Bloating in past 24 hours - day 21
293 dd233f Char 1 33f Upper abdominal pain in past 24 hours - day 21
294 dd233g Char 2 33g Episodes of vomiting in past 24 hours - day 21
295 dd233h Char 2 33h Episodes of retching in past 24 hours - day 21
296 dd233i Char 2 33i Hours of nausea in past 24 hours - day 21
297 dd233j Char 1 33j Overall severity of GP sx in past 24 hours - day 21
298 dd233k Char 1 33k Form completion - day 21
299 dd233ks Char 35 33k Specify other time form completed - day 21
300 dd233l Char 1 33l Took study drug today - day 21
301 formdate Num 8 4 Form date (days since enrollment)
04:05 Friday, October 23, 2020 24
Data Set Name: ds.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 ds108 Char 2 8 Number of diaries completed
6 ds108a Char 1 8a Were 7 diaries completed
7 ds109 Char 3 9 Calibration line length
8 ds110a Char 3 10a Sum of nausea VAS scores
9 ds110b Char 3 10b Mean of nausea VAS scores
10 ds110c Char 1 10c Mean nausea VAS 25mm or greater
11 ds113 Char 3 13 Nausea score - day 1
12 ds113a Char 1 13a Nausea in past 24 hours - day 1
13 ds113b Char 1 13b Vomiting in past 24 hours - day 1
14 ds113c Char 1 13c Unable to finish meal in past 24 hours - day 1
15 ds113d Char 1 13d Feel excess. full in past 24 hours - day 1
16 ds113e Char 1 13e Bloating in past 24 hours - day 1
17 ds113f Char 1 13f Upper abdominal pain in past 24 hours - day 1
18 ds113g Char 2 13g Episodes of vomiting in past 24 hours - day 1
19 ds113h Char 2 13h Episodes of retching in past 24 hours - day 1
20 ds113i Char 2 13i Hours of nausea in past 24 hours - day 1
21 ds113j Char 1 13j Overall severity of GP sx in past 24 hours - day 1
22 ds113k Char 1 13k Form completion - day 1
23 ds113ks Char 35 13k Specify other time form completed - day 1
24 ds114 Char 3 14 Nausea score - day 2
25 ds114a Char 1 14a Nausea in past 24 hours - day 2
26 ds114b Char 1 14b Vomiting in past 24 hours - day 2
27 ds114c Char 1 14c Unable to finish meal in past 24 hours - day 2
28 ds114d Char 1 14d Feel excess. full in past 24 hours - day 2
29 ds114e Char 1 14e Bloating in past 24 hours - day 2
30 ds114f Char 1 14f Upper abdominal pain in past 24 hours - day 2
31 ds114g Char 2 14g Episodes of vomiting in past 24 hours - day 2
32 ds114h Char 2 14h Episodes of retching in past 24 hours - day 2
33 ds114i Char 2 14i Hours of nausea in past 24 hours - day 2
34 ds114j Char 1 14j Overall severity of GP sx in past 24 hours - day 2
35 ds114k Char 1 14k Form completion - day 2
36 ds114ks Char 35 14k Specify other time form completed - day 2
37 ds115 Char 3 15 Nausea score - day 3
04:05 Friday, October 23, 2020 25
Num Variable Type Len Label 38 ds115a Char 1 15a Nausea in past 24 hours - day 3
39 ds115b Char 1 15b Vomiting in past 24 hours - day 3
40 ds115c Char 1 15c Unable to finish meal in past 24 hours - day 3
41 ds115d Char 1 15d Feel excess. full in past 24 hours - day 3
42 ds115e Char 1 15e Bloating in past 24 hours - day 3
43 ds115f Char 1 15f Upper abdominal pain in past 24 hours - day 3
44 ds115g Char 2 15g Episodes of vomiting in past 24 hours - day 3
45 ds115h Char 2 15h Episodes of retching in past 24 hours - day 3
46 ds115i Char 2 15i Hours of nausea in past 24 hours - day 3
47 ds115j Char 1 15j Overall severity of GP sx in past 24 hours - day 3
48 ds115k Char 1 15k Form completion - day 3
49 ds115ks Char 35 15k Specify other time form completed - day 3
50 ds116 Char 3 16 Nausea score - day 4
51 ds116a Char 1 16a Nausea in past 24 hours - day 4
52 ds116b Char 1 16b Vomiting in past 24 hours - day 4
53 ds116c Char 1 16c Unable to finish meal in past 24 hours - day 4
54 ds116d Char 1 16d Feel excess. full in past 24 hours - day 4
55 ds116e Char 1 16e Bloating in past 24 hours - day 4
56 ds116f Char 1 16f Upper abdominal pain in past 24 hours - day 4
57 ds116g Char 2 16g Episodes of vomiting in past 24 hours - day 4
58 ds116h Char 2 16h Episodes of retching in past 24 hours - day 4
59 ds116i Char 2 16i Hours of nausea in past 24 hours - day 4
60 ds116j Char 1 16j Overall severity of GP sx in past 24 hours - day 4
61 ds116k Char 1 16k Form completion - day 4
62 ds116ks Char 35 16k Specify other time form completed - day 4
63 ds117 Char 3 17 Nausea score - day 5
64 ds117a Char 1 17a Nausea in past 24 hours - day 5
65 ds117b Char 1 17b Vomiting in past 24 hours - day 5
66 ds117c Char 1 17c Unable to finish meal in past 24 hours - day 5
67 ds117d Char 1 17d Feel excess. full in past 24 hours - day 5
68 ds117e Char 1 17e Bloating in past 24 hours - day 5
69 ds117f Char 1 17f Upper abdominal pain in past 24 hours - day 5
70 ds117g Char 2 17g Episodes of vomiting in past 24 hours - day 5
71 ds117h Char 2 17h Episodes of retching in past 24 hours - day 5
72 ds117i Char 2 17i Hours of nausea in past 24 hours - day 5
73 ds117j Char 1 17j Overall severity of GP sx in past 24 hours - day 5
74 ds117k Char 1 17k Form completion - day 5
75 ds117ks Char 35 17k Specify other time form completed - day 5
76 ds118 Char 3 18 Nausea score - day 6
04:05 Friday, October 23, 2020 26
Num Variable Type Len Label 77 ds118a Char 1 18a Nausea in past 24 hours - day 6
78 ds118b Char 1 18b Vomiting in past 24 hours - day 6
79 ds118c Char 1 18c Unable to finish meal in past 24 hours - day 6
80 ds118d Char 1 18d Feel excess. full in past 24 hours - day 6
81 ds118e Char 1 18e Bloating in past 24 hours - day 6
82 ds118f Char 1 18f Upper abdominal pain in past 24 hours - day 6
83 ds118g Char 2 18g Episodes of vomiting in past 24 hours - day 6
84 ds118h Char 2 18h Episodes of retching in past 24 hours - day 6
85 ds118i Char 2 18i Hours of nausea in past 24 hours - day 6
86 ds118j Char 1 18j Overall severity of GP sx in past 24 hours - day 6
87 ds118k Char 1 18k Form completion - day 6
88 ds118ks Char 35 18k Specify other time form completed - day 6
89 ds119 Char 3 19 Nausea score - day 7
90 ds119a Char 1 19a Nausea in past 24 hours - day 7
91 ds119b Char 1 19b Vomiting in past 24 hours - day 7
92 ds119c Char 1 19c Unable to finish meal in past 24 hours - day 7
93 ds119d Char 1 19d Feel excess. full in past 24 hours - day 7
94 ds119e Char 1 19e Bloating in past 24 hours - day 7
95 ds119f Char 1 19f Upper abdominal pain in past 24 hours - day 7
96 ds119g Char 2 19g Episodes of vomiting in past 24 hours - day 7
97 ds119h Char 2 19h Episodes of retching in past 24 hours - day 7
98 ds119i Char 2 19i Hours of nausea in past 24 hours - day 7
99 ds119j Char 1 19j Overall severity of GP sx in past 24 hours - day 7
100 ds119k Char 1 19k Form completion - day 7
101 ds119ks Char 35 19k Specify other time form completed - day 7
102 formdate Num 8 4 Form date (days since enrollment)
04:05 Friday, October 23, 2020 27
Data Set Name: eg.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 eg108a Char 1 8a Date within 2 years of registration
6 eg109 Char 1 9 Ineligible due to endoscopic findings
7 formdate Num 8 4 Form date (days since enrollment)
8 eg108 Num 8 8 Date of upper endoscopy (days since enrollment)
04:05 Friday, October 23, 2020 28
Data Set Name: fh.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 fh109a Char 1 9a Diabetes type 1 or 2
6 fh109b Char 1 9b Pyloric obstruction
7 fh109c Char 1 9c Intestinal obstruction
8 fh109d Char 1 9d Advanced liver disease (CPT score >=10)
9 fh109e Char 1 9e Inflammatory bowel disease
10 fh109f Char 1 9f Thyroid disease
11 fh109g Char 1 9g Peptic ulcer disease
12 fh109h Char 1 9h Gastroesophageal reflux disease
13 fh109i Char 1 9i Interstitial cystitis
14 fh109j Char 1 9j Bladder dysfunction
15 fh109k Char 1 9k Diverticulosis
16 fh109l Char 1 9l Endometriosis
17 fh109m Char 1 9m Blood clots
18 fh109n Char 1 9n Hemophilia
19 fh109o Char 1 9o Systemic lupus erythematosus (SLE)
20 fh109p Char 1 9p Rheumatoid arthritis
21 fh109q Char 1 9q Fibromyalgia
22 fh109r Char 1 9r Scleroderma
23 fh109s Char 1 9s Malignancy
24 fh109t Char 1 9t Migraine headaches
25 fh109u Char 1 9u Hypertension
26 fh109v Char 1 9v Coronary artery disease
27 fh109w Char 1 9w Cerebrovascular disease
28 fh109x Char 1 9x Hyperlipidemia
29 fh109y Char 1 9y Myocardial infarction
30 fh109z Char 1 9z Pancreatitis
31 fh109aa Char 1 9aa Cholelithiasis
32 fh109ab Char 1 9ab Gallbladder disease
33 fh109ac Char 1 9ac Polycystic ovary syndrome
34 fh109ad Char 1 9ad Myopathy
35 fh109ae Char 1 9ae Multiple sclerosis
36 fh109af Char 1 9af Eating disorders
37 fh109ag Char 1 9ag Major depression
04:05 Friday, October 23, 2020 29
Num Variable Type Len Label 38 fh109ah Char 1 9ah Schizophrenia
39 fh109ai Char 1 9ai Bipolar disorder
40 fh109aj Char 1 9aj Obsessive compulsive disorder
41 fh109ak Char 1 9ak Severe anxiety or personality disorder
42 fh109al Char 1 9al Dyslexia or learning problems
43 fh109am Char 1 9am Other diagnosis #1
44 fh109ams Char 35 9am Specify other diagnosis
45 fh109an Char 1 9an Other diagnosis #2
46 fh109ans Char 35 9an Specify other diagnosis
47 fh109ao Char 1 9ao Other diagnosis #3
48 fh109aos Char 35 9ao Specify other diagnosis
49 fh109ap Char 1 9ap None of the above
50 fh110 Char 1 10 Any proton pump inhibitors since last visit
51 fh110a Char 1 10a Antacids
52 fh110as Char 35 10a Specify antacids
53 fh110b Char 1 10b Cimetidine (Tagamet)
54 fh110c Char 1 10c Dexlansoprazole (Dexilant)
55 fh110d Char 1 10d Esomeprazole (Nexium)
56 fh110e Char 1 10e Famotidine (Pepcid)
57 fh110f Char 1 10f Lansoprazole (Prevacid)
58 fh110g Char 1 10g Nizatidine (Axid)
59 fh110h Char 1 10h Omeprazole (Prilosec)
60 fh110i Char 1 10i Pantoprazole (Protonix)
61 fh110j Char 1 10j Rabeprazole (Aciphex)
62 fh110k Char 1 10k Rantidine (Zantac)
63 fh110l Char 1 10l Other
64 fh110ls Char 35 10l Specify other
65 fh111 Char 1 11 Any benzodiazepines since last visit
66 fh111a Char 1 11a Alprazolam (Xanax)
67 fh111b Char 1 11b Buspirone (BuSpar)
68 fh111c Char 1 11c Chlordiazepoxide (Librax)
69 fh111d Char 1 11d Clonazepam (Klonopin)
70 fh111e Char 1 11e Diazepam (Valium)
71 fh111f Char 1 11f Flurazepam (Dalmane)
72 fh111g Char 1 11g Lorazepam (Ativan)
73 fh111h Char 1 11h Midazolam (Versed)
74 fh111i Char 1 11i Oxazepam (Serax)
75 fh111j Char 1 11j Quazepam (Doral)
76 fh111k Char 1 11k Quetiapine fumarate (Seroquel)
04:05 Friday, October 23, 2020 30
Num Variable Type Len Label 77 fh111l Char 1 11l Temazepam (Restoril)
78 fh111m Char 1 11m Triazolam (Halcon)
79 fh111n Char 1 11n Other
80 fh111ns Char 35 11n Specify other
81 fh112 Char 1 12 Cisapride, warfarin, pimozide, ...
82 fh113 Char 1 13 Any prokinetic medicines since last visit
83 fh113a Char 1 13a Azithromycin (Zithromax)
84 fh113b Char 1 13b Bethanechol (Duvoid)
85 fh113c Char 1 13c Botulinum toxin (Botox)
86 fh113d Char 1 13d Clarithromycin (Biaxin)
87 fh113e Char 1 13e Domperidone (Motilium)
88 fh113f Char 1 13f Erythromycin
89 fh113g Char 1 13g Metoclopramide (Reglan)
90 fh113h Char 1 13h Other prokinetic medications
91 fh113hs Char 35 13h Specify other prokinetic medications
92 fh114 Char 1 14 Antiemetic medications since last visit
93 fh114a Char 1 14a Dolasetron (Anzemet)
94 fh114b Char 1 14b Dronabinol (Marinol)
95 fh114c Char 1 14c Granisetron (Kytril)
96 fh114d Char 1 14d Meclizine (Antivert)
97 fh114e Char 1 14e Ondansetron (Zofran)
98 fh114f Char 1 14f Palonosetron (Aloxi)
99 fh114g Char 1 14g Prochlorperazine (Compazine)
100 fh114h Char 1 14h Promethazine (Pentazine)
101 fh114i Char 1 14i Tetrahydrocannabinol (THC)
102 fh114j Char 1 14j Trimethobenzamide (Benzacot)
103 fh114k Char 1 14k Tropisetron (Navoban)
104 fh114l Char 1 14l Other antiemetic medications
105 fh114ls Char 35 14l Specify other antiemetic medications
106 fh115 Char 1 15 Any SSRIs since last visit
107 fh115a Char 1 15a Citalopram (Celexa)
108 fh115b Char 1 15b Escitalopram (Lexapro)
109 fh115c Char 1 15c Fluxetine (Prozac)
110 fh115d Char 1 15d Fluvoxamine (Luvox)
111 fh115e Char 1 15e Parozetine (Paxil)
112 fh115f Char 1 15f Sertraline (Zoloft)
113 fh115g Char 1 15g Other SSRI
114 fh115gs Char 35 15g Specify other SSRI
115 fh116 Char 1 16 Any tricyclic antidepressants since last visit
04:05 Friday, October 23, 2020 31
Num Variable Type Len Label 116 fh116a Char 1 16a Amitriptyline (Elavil)
117 fh116b Char 1 16b Amoxapine (Asendin)
118 fh116c Char 1 16c Clomipramine (Anafranil)
119 fh116d Char 1 16d Desipramine (Norpramin)
120 fh116e Char 1 16e Doxein (Sinequan)
121 fh116f Char 1 16f Imipramine (Tofranil)
122 fh116g Char 1 16g Nortriptyline (Pamelor)
123 fh116h Char 1 16h Trimipramin (Surmontil)
124 fh116i Char 1 16i Protriptyline (Pliva, Vivactil)
125 fh116j Char 1 16j Other tricyclic antidepressants
126 fh116js Char 35 16j Specify other tricyclic antidepressants
127 fh117 Char 1 17 Narcotic pain medications since last visit
128 fh117a Char 1 17a Buprenorphine
129 fh117b Char 1 17b Butalbital combination
130 fh117c Char 1 17c Codeine combinations
131 fh117d Char 1 17d Fentanyl
132 fh117e Char 1 17e Fentanyl patch
133 fh117f Char 1 17f Hydrocodone combinations
134 fh117g Char 1 17g Hydromorphone
135 fh117h Char 1 17h Methadone
136 fh117i Char 1 17i Morphine sulfate
137 fh117j Char 1 17j Oxycodone combinations
138 fh117k Char 1 17k Pentazocine
139 fh117l Char 1 17l Propoxyphene combinations
140 fh117m Char 1 17m Tapentadol
141 fh117n Char 1 17n Tramadol
142 fh117o Char 1 17o Other narcotic pain medications
143 fh117os Char 35 17o Specify narcotic pain medications
144 fh118 Char 1 18 Other medications since last visit
145 fh118a Char 1 18a Aripiprazole (Abilify)
146 fh118b Char 1 18b Brupropion (Wellbutrin)
147 fh118c Char 1 18c Divalproex sodium (Depakote)
148 fh118d Char 1 18d Duloxetine (Cymbalta)
149 fh118e Char 1 18e Gabapentin (Neurontin)
150 fh118f Char 1 18f Haloperidol (Haldol)
151 fh118g Char 1 18g Lamotrigine (Lamictal)
152 fh118h Char 1 18h Maprotiline (Ludiomil)
153 fh118i Char 1 18i Mirtazipine (Remeron)
154 fh118j Char 1 18j Olanzapine (Zyprexa)
04:05 Friday, October 23, 2020 32
Num Variable Type Len Label 155 fh118k Char 1 18k Pregabalin (Lyrica)
156 fh118l Char 1 18l Venlafaxine (Effexor)
157 fh118m Char 1 18m Ziprasidone (Geodon)
158 fh118n Char 1 18n Other medication
159 fh118ns Char 35 18n Specify other medication
160 fh118o Char 1 18o Other medication
161 fh118os Char 35 18o Specify other medication
162 fh118p Char 1 18p Other medication
163 fh118ps Char 35 18p Specify other medication
164 fh119 Char 1 19 CGPI
165 formdate Num 8 4 Form date (days since enrollment)
166 fh108 Num 8 8 Date of last Follow-up Medical History (days since enrollment)
04:05 Friday, October 23, 2020 33
Data Set Name: gd.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 gd108 Char 2 8 Nausea subscore
6 gd109 Char 2 9 Fullness/Satiety subscore
7 gd110 Char 2 10 Bloating subscore
8 gd111 Char 2 11 Total GSCI score
9 gd112 Char 1 12 s visit and GSCI score<21
10 gd115 Char 1 15 Nausea
11 gd116 Char 1 16 Retching
12 gd117 Char 1 17 Vomiting
13 gd118 Char 1 18 Stomach fullness
14 gd119 Char 1 19 Unable to finish normal-size meal
15 gd120 Char 1 20 Feel full after meals
16 gd121 Char 1 21 Loss of appetite
17 gd122 Char 1 22 Bloating
18 gd123 Char 1 23 Stomach or belly visibly larger
19 gd124 Char 1 24 Upper abdominal pain
20 gd125 Char 1 25 Upper abdominal discomfort
21 gd126 Char 1 26 Lower abdominal pain
22 gd127 Char 1 27 Lower abdominal discomfort
23 gd128 Char 1 28 Heartburn during day
24 gd129 Char 1 29 Heartburn when lying down
25 gd130 Char 1 30 Chest discomfort during day
26 gd131 Char 1 31 Chest discomfort during night
27 gd132 Char 1 32 Regurgitation during day
28 gd133 Char 1 33 Regurgitation when lying down
29 gd134 Char 1 34 Bitter/sour/acid taste in mouth
30 gd135 Char 1 35 Constipation
31 gd136 Char 1 36 Diarrhea
32 gd137 Char 2 37 Predominant symptom
33 formdate Num 8 4 Form date (days since enrollment)
04:05 Friday, October 23, 2020 34
Data Set Name: ge.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 ge109 Num 8 9 Date within 2 years of APRON registration
6 ge110 Num 8 10 Meal given for test
7 ge110s Char 35 10 Specify other meal
8 ge111a Num 8 11a Amount of meal consumed
9 ge111b Num 8 11b Amount of water consumed
10 ge112 Num 8 12 Did patient vomit during tests
11 ge113a Num 8 13a 0 minutes: percent retention
12 ge113b Num 8 13b 30 minutes: percent retention
13 ge113c Num 8 13c 1 hour: percent retention
14 ge113d Num 8 13d 2 hours: percent retention
15 ge113e Num 8 13e 3 hours: percent retention
16 ge113f Num 8 13f 4 hours: percent retention
17 ge114s Char 35 14 Interpretation
18 ge114t Char 35 14 Interpretation
19 ge114u Char 35 14 Interpretation
20 ge115s Char 35 15 Comments
21 ge115t Char 35 15 Comments
22 ge115u Char 35 15 Comments
23 ge115v Char 35 15 Comments
24 ge116a Num 8 16a Gastric emptying test completed
25 ge116b Num 8 16b Abnormal 2- or 4-hour values
26 ge116c Num 8 16c 2-hour value greater than 60%
27 ge116d Num 8 16d 4-hour value greater than 10%
28 formdate Num 8 4 Form date (days since enrollment)
29 ge108 Num 8 8 Gastric emptying scintigraphy date (days before enrollment)
04:05 Friday, October 23, 2020 35
Data Set Name: gs.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 gs111 Char 1 11 Stomach ache or pain in past week
6 gs112 Char 1 12 Heartburn in past week
7 gs113 Char 1 13 Acid reflux in past week
8 gs114 Char 1 14 Hunger pains in belly in past week
9 gs115 Char 1 15 Nausea in past week
10 gs116 Char 1 16 Stomach rumbling in past week
11 gs117 Char 1 17 Stomach felt bloated in past week
12 gs118 Char 1 18 Bothered by burping in past week
13 gs119 Char 1 19 Gas or flatus in past week
14 gs120 Char 1 20 Constipated in past week
15 gs121 Char 1 21 Diarrhea in past week
16 gs122 Char 1 22 Loose stools in past week
17 gs123 Char 1 23 Hard stools in past week
18 gs124 Char 1 24 Urgent need for bowel movement in past week
19 gs125 Char 1 25 Incomplete bowel emptying in past week
20 formdate Num 8 4 Form date (days since enrollment)
04:05 Friday, October 23, 2020 36
Data Set Name: lr.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 lr109 Num 8 9 Hemoglobin
6 lr110 Num 8 10 Hematocrit
7 lr111 Num 8 11 White blood cell count
8 lr112 Num 8 12 Red blood cell count
9 lr113 Num 8 13 Platelet count
10 lr115 Num 8 15 Carbon dioxide
11 lr116 Num 8 16 Chloride
12 lr117 Num 8 17 Sodium
13 lr118 Num 8 18 Potassium
14 lr119 Num 8 19 Glucose
15 lr120 Num 8 20 Calcium
16 lr121 Num 8 21 Magnesium (mg/dL)
17 lr122 Num 8 22 BUN - Blood urea nitrogen
18 lr123 Num 8 23 Creatinine
19 lr124 Num 8 24 Total protein g/dL
20 lr125 Num 8 25 Albumin g/dL
21 lr126 Num 8 26 Alanine aminotransferease (ALT)
22 lr127 Num 8 27 ALT ULN
23 lr128 Num 8 28 Aspartate aminotransferase (AST)
24 lr129 Num 8 29 AST ULN
25 lr130 Num 8 30 HbA1c result required
26 lr132 Num 8 32 HbA1c (%
27 lr133 Num 8 33 Screening visit
28 lr134 Num 8 34 All screening laboratory results completed
29 lr135 Num 8 35 ALT or AST > 2x ULN
30 formdate Num 8 4 Form date (days since enrollment)
31 lr108 Num 8 8 Date of blood draw for complete blood count (days since enrollment)
32 lr114 Num 8 14 Date of blood draw for metabolic panel (days since enrollment)
33 lr131 Num 8 31 Date of blood draw for HbA1c (days since enrollment)
04:05 Friday, October 23, 2020 37
Data Set Name: np.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 np110 Char 1 10 I feel shaky
6 np111 Char 1 11 I feel upset
7 np112 Char 1 12 I feel lightheaded
8 np113 Char 1 13 I feel sick
9 np114 Char 1 14 I feel sweaty
10 np115 Char 1 15 I feel queasy
11 np116 Char 1 16 I feel worried
12 np117 Char 1 17 I feel hopeless
13 np118 Char 1 18 I feel fatigued/tired
14 np119 Char 1 19 I feel panicked
15 np120 Char 1 20 I feel nervous
16 np121 Char 1 21 I feel scared/afraid
17 np122 Char 1 22 I feel ill
18 np123 Char 1 23 I feel discomfort in my stomach
19 np124 Char 1 24 I feel as if I might vomit
20 np125 Char 1 25 I feel weak
21 np126 Char 1 26 I hot/warm
22 np127 Char 7 27 Today's date
23 formdate Num 8 4 Form date (days since enrollment)
04:05 Friday, October 23, 2020 38
Data Set Name: pe.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 pe108a Num 8 8a Temperature (degrees)
6 pe108b Num 8 8b Scale for temperature
7 pe109a Num 8 9a Systolic BP (mmHg)
8 pe109b Num 8 9b Diastolic BP (mmHg)
9 pe110 Num 8 10 Resting radial pulse (beats/min)
10 pe111 Num 8 11 Respiratory rate (breaths/min)
11 pe112a Num 8 12a Height
12 pe112b Num 8 12b Units of height measurement
13 pe113a Num 8 13a Weight
14 pe113b Num 8 13b Units of weight measurement
15 pe114a Num 8 14a Waist circumference
16 pe114b Num 8 14b Units for waist measurement
17 pe115a Num 8 15a Hip circumference
18 pe115b Num 8 15b Units for hip measurement
19 pe116 Num 8 16 Chest and lungs
20 pe116s Char 35 16 Specify chest/lungs abnormality
21 pe117 Num 8 17 Heart
22 pe117s Char 35 17 Specify heart abnormality
23 pe117t Char 35 17 Specify heart abnormality
24 pe118 Num 8 18 Abdomen
25 pe119a Num 8 19a Distention
26 pe119b Num 8 19b Tympany
27 pe119c Num 8 19c Succussion splash
28 pe119d Num 8 19d Tenderness
29 pe119e Num 8 19e Organomegaly
30 pe119f Num 8 19f Other abdomen abnormality
31 pe119fs Char 35 19f Specify abdomen abnormality
32 pe119ft Char 35 19f Specify abdomen abnormality
33 pe120 Num 8 20 Liver and spleen
34 pe120s Char 35 20 Specify liver/spleen abnormality
35 pe121 Num 8 21 Nervous system
36 pe121s Char 35 21 Specify nervous system abnormality
37 pe121t Char 35 21 Specify nervous system abnormality
04:05 Friday, October 23, 2020 39
Num Variable Type Len Label 38 pe122 Num 8 22 Other abnormalities
39 pe122s Char 35 22 Specify other abnormalities
40 pe122t Char 35 22 Specify other abnormalities
41 pe124 Num 8 24 QTc interval
42 formdate Num 8 4 Form date (days since enrollment)
43 pe123 Num 8 23 Date of electrocardiogram (days since enrollment
04:05 Friday, October 23, 2020 40
Data Set Name: pi.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 pi110 Char 1 10 Pain besides everyday aches
6 pi111 Char 2 11 Rate worst pain in last 24 hrs
7 pi112 Char 2 12 Rate least pain in last 24 hrs
8 pi113 Char 2 13 Rate average pain
9 pi114 Char 2 14 Rate current pain
10 pi115 Char 1 15 Medications/treatments for pain
11 pi116s Char 35 16 Pain medications
12 pi116t Char 35 16 Pain medications
13 pi116u Char 35 16 Pain medications
14 pi117 Char 3 17 Percent relief in last 24 hours
15 pi118a Char 2 18a General activity
16 pi118b Char 2 18b Mood
17 pi118c Char 2 18c Walking ability
18 pi118d Char 2 18d Normal work
19 pi118e Char 2 18e Relations with people
20 pi118f Char 2 18f Sleep
21 pi118g Char 2 18g Enjoyment of life
22 formdate Num 8 4 Form date (days since enrollment)
23 pi119 Num 8 19 Date form completed (days since enrollment)
04:05 Friday, October 23, 2020 41
Data Set Name: pq.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 pq110a Char 1 10a Stomach pain
6 pq110b Char 1 10b Back pain
7 pq110c Char 1 10c Pain in arms, legs, joints
8 pq110d Char 1 10d Menstrual cramps
9 pq110e Char 1 10e Headaches
10 pq110f Char 1 10f Chest pain
11 pq110g Char 1 10g Dizziness
12 pq110h Char 1 10h Fainting spells
13 pq110i Char 1 10i Feel heart pound or race
14 pq110j Char 1 10j Shortness of breath
15 pq110k Char 1 10k Pain during sexual intercourse
16 pq110l Char 1 10l Constipation, loose bowels or diarrhea
17 pq110m Char 1 10m Nausea, gas, or indigestion
18 pq110n Char 1 10n Feel tired or low energy
19 pq110o Char 1 10o Trouble sleeping
20 formdate Num 8 4 Form date (days since enrollment)
04:05 Friday, October 23, 2020 42
Data Set Name: qf.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 qf110 Char 1 10 In general, health is
6 qf111 Char 1 11 Rate health compared to one year ago
7 qf112a Char 1 12a Limit vigorous activities
8 qf112b Char 1 12b Limit moderate activities
9 qf112c Char 1 12c Limit lifting/carrying groceries
10 qf112d Char 1 12d Limit climbing several stair flights
11 qf112e Char 1 12e Limit climbing one stair flight
12 qf112f Char 1 12f Limit bending, kneeling, stooping
13 qf112g Char 1 12g Limit walking more than a mile
14 qf112h Char 1 12h Limit walking several hundred yards
15 qf112i Char 1 12i Limit walking one hundred yards
16 qf112j Char 1 12j Limit bathing/dressing self
17 qf113a Char 1 13a Cut down activity time-health problem
18 qf113b Char 1 13b Accomplished less-health problem
19 qf113c Char 1 13c Limited activities-health problem
20 qf113d Char 1 13d Difficulty doing work-health problem
21 qf114a Char 1 14a Cut down activities-emotional problems
22 qf114b Char 1 14b Accomplished less-emotional problems
23 qf114c Char 1 14c Did activities less carefully-emotional problems
24 qf115 Char 1 15 Health/emotions interfere with social activities
25 qf116 Char 1 16 How much bodily pain in past 4 weeks
26 qf117 Char 1 17 Did pain interfere with normal work
27 qf118a Char 1 18a Did you feel full of life
28 qf118b Char 1 18b Have you been very nervous
29 qf118c Char 1 18c Have you felt down in dumps
30 qf118d Char 1 18d Have you felt calm and peaceful
31 qf118e Char 1 18e Did you have a lot of energy
32 qf118f Char 1 18f Have you felt downhearted/depressed
33 qf118g Char 1 18g Did you feel worn out
34 qf118h Char 1 18h Have you been happy
35 qf118i Char 1 18i Did you feel tired
36 qf119 Char 1 19 Problems interfered w/social activities
37 qf120a Char 1 20a Seem to get sick easier than other people
04:05 Friday, October 23, 2020 43
Num Variable Type Len Label 38 qf120b Char 1 20b Healthy as anybody I know
39 qf120c Char 1 20c Expect health to get worse
40 qf120d Char 1 20d Health is excellent
41 qf121 Char 7 21 Date form completed
42 formdate Num 8 4 Form date (days since enrollment)
04:05 Friday, October 23, 2020 44
Data Set Name: rd.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 rd108 Char 1 8 Drug dispensing visit
6 rd110 Char 1 10 How study drugs were dispensed
7 rd111 Char 1 11 Study drug bottle returned
8 rd112b Char 2 12b Number of capsules returned
9 formdate Num 8 4 Form date (days since randomization)
04:05 Friday, October 23, 2020 45
Data Set Name: rg.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 rg108 Char 1 8 Signed APRON informed consent
6 rg109 Char 1 9 Coordinator/physician signed consent
7 rg111 Char 2 11 Age at last birthday
8 rg112 Char 1 12 At least 18 years old
9 rg113 Char 1 13 Gender
10 rg114 Char 1 14 Ethnic category
11 rg115a Char 1 15a American Indian/Alaska Native
12 rg115b Char 1 15b Asian
13 rg115c Char 1 15c Black/African American
14 rg115d Char 1 15d Native Hawaiian/Pacific Islander
15 rg115e Char 1 15e White
16 rg115f Char 1 15f Refused
17 rg116 Char 1 16 Highest educational level
18 rg117 Char 1 17 Occupational history
19 rg117s Char 35 17 Specify other category
20 rg118 Char 1 18 Marital status
21 rg119 Char 1 19 Annual household income before taxes
22 rg120 Char 1 20 Previously registered
23 rg121a Char 1 21a Gastroparesis Registry
24 rg121b Char 1 21b Gastroparesis Registry 2
25 rg121c Char 1 21c NORIG
26 rg121d Char 1 21d GLUMIT-DG
27 rg121e Char 1 21e Other GpCRC study
28 rg121es Char 35 21e Specify other GpCRC study
29 formdate Num 8 4 Form date (days since enrollment)
30 rg110 Num 8 10 Birth date (days before enrollment)
04:05 Friday, October 23, 2020 46
Data Set Name: se.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 se108a Char 2 8a Form Y-1 score
6 se108b Char 2 8b Form Y-2 score
7 formdate Num 8 4 Form date (days since enrollment)
04:05 Friday, October 23, 2020 47
Data Set Name: st.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 visit Char 4 5 Visit ID code
3 form Char 4 6 Form/revision
4 study Char 1 7 Study
5 st108 Num 8 8 Fasted since midnight
6 st109 Num 8 9 Patient is diabetic
7 st110 Num 8 10 Blood glucose between 60 and 275 mg/dL
8 st111 Num 8 11 Blood glucose (mg/dL)
9 st112 Num 8 12 Other hypoglycemia or hyperglycemia symptoms
10 st113 Num 8 13 Length of calibration line (mm)
11 st114a Num 8 14a BL 1: Stomach fullness
12 st114b Num 8 14b BL 1: Hunger
13 st114c Num 8 14c BL 1: Nausea
14 st114d Num 8 14d BL 1: Bloating
15 st114e Num 8 14e BL 1: Abdominal discomfort
16 st115a Num 8 15a BL 2: Stomach fullness
17 st115b Num 8 15b BL 2: Hunger
18 st115c Num 8 15c BL 2: Nausea
19 st115d Num 8 15d BL 2: Bloating
20 st115e Num 8 15e BL 2: Abdominal discomfort
21 st116 Num 8 16 Time satiety test started
22 st117 Num 8 17 Time satiety test ended
23 st118 Num 8 18 Total Ensure volume consumed (mL)
24 st119a Num 8 19a Post satiety: Stomach fullness
25 st119b Num 8 19b Post satiety: Hunger
26 st119c Num 8 19c Post satiety: Nausea
27 st119d Num 8 19d Post satiety: Bloating
28 st119e Num 8 19e Post satiety: Abdominal discomfort
29 st120a Num 8 20a 15min post: Stomach fullness
30 st120b Num 8 20b 15min post: Hunger
31 st120c Num 8 20c 15min post: Nausea
32 st120d Num 8 20d 15min post: Bloating
33 st120e Num 8 20e 15min post: Abdominal discomfort
34 st121a Num 8 21a 30min post: Stomach fullness
35 st121b Num 8 21b 30min post: Hunger
36 st121c Num 8 21c 30min post: Nausea
37 st121d Num 8 21d 30min post: Bloating
04:05 Friday, October 23, 2020 48
Num Variable Type Len Label 38 st121e Num 8 21e 30min post: Abdominal discomfort
39 st122 Num 8 22 Duration of baseline 0-15 minute
40 st123 Num 8 23 Duration of post satiety test 0-15 min
41 st124 Num 8 24 Duration of post satiety test 16-30 min
42 st125a Num 8 25a Bl: 1-<2.5 cpm (%)
43 st125b Num 8 25b Bl: 2.5-<3.8 cpm (%)
44 st125c Num 8 25c Bl: 3.8-10 cpm (%)
45 st125d Num 8 25d Bl: >10-15 cpm (%)
46 st125e Num 8 25e 0-15 post: 1-<2.5 cpm (%)
47 st125f Num 8 25f 0-15 post: 2.5-<3.8 cpm (%)
48 st125g Num 8 25g 0-15 post: 3.8-10 cpm (%)
49 st125h Num 8 25h 0-15 post: >10-15 cpm (%)
50 st125i Num 8 25i 16-30 post: 1-<2.5 cpm (%)
51 st125j Num 8 25j 16-30 post: 2.5-<3.8 cpm (%)
52 st125k Num 8 25k 16-30 post: 3.8-10 cpm (%)
53 st125l Num 8 25l 16-30 post: >10-15 cpm (%)
54 st126a Num 8 26a 0-15 post: 1-<2.5 cpm (ratio)
55 st126b Num 8 26b 0-15 post: 2.5-<3.8 cpm (ratio)
56 st126c Num 8 26c 0-15 post: 3.8-10 cpm (ratio)
57 st126d Num 8 26d 0-15 post: >10-15 cpm (ratio)
58 st126e Num 8 26e 16-30 post: 1-<2.5 cpm (ratio)
59 st126f Num 8 26f 16-30 post: 2.5-<3.8 cpm (ratio)
60 st126g Num 8 26g 16-30 post: 3.8-10 cpm (ratio)
61 st126h Num 8 26h 16-30 post: >10-15 cpm (ratio)
62 st127a Num 8 27a Bl: 1-<2.5 cpm (x.x+exxx)
63 st127b Num 8 27b Bl: 2.5-<3.8 cpm (x.x+exxx)
64 st127c Num 8 27c Bl: 3.8-10 cpm (x.x+exxx)
65 st127d Num 8 27d Bl: >10-15 cpm (x.x+exxx)
66 st127e Num 8 27e 0-15 post: 1-<2.5 cpm (x.x+exxx)
67 st127f Num 8 27f 0-15 post: 2.5-<3.8 cpm (x.x+exxx)
68 st127g Num 8 27g 0-15 post: 3.8-10 cpm (x.x+exxx)
69 st127h Num 8 27h 0-15 post: >10-15 cpm (x.x+exxx)
70 st127i Num 8 27i 16-30 post: 1-<2.5 cpm (x.x+exxx)
71 st127j Num 8 27j 16-30 post: 2.5-<3.8 cpm (x.x+exxx)
72 st127k Num 8 27k 16-30 post: 3.8-10 cpm (x.x+exxx)
73 st127l Num 8 27l 16-30 post: >10-15 cpm (x.x+exxx)
74 st128a Num 8 28a Baseline: Avg dominant frequency
75 st128b Num 8 28b 0-15 post: Avg dominant frequency
76 st128c Num 8 28c 16-30 post: Avg dominant frequency
04:05 Friday, October 23, 2020 49
Num Variable Type Len Label 77 st129a Num 8 29a Bl: 1-<2.5 cpm (%)
78 st129b Num 8 29b Bl: 2.5-<3.8 cpm (%)
79 st129c Num 8 29c Bl: 3.8-10 cpm (%)
80 st129d Num 8 29d Bl: >10-15 cpm (%)
81 st129e Num 8 29e 0-15 post: 1-<2.5 cpm (%)
82 st129f Num 8 29f 0-15 post: 2.5-<3.8 cpm (%)
83 st129g Num 8 29g 0-15 post: 3.8-10 cpm (%)
84 st129h Num 8 29h 0-15 post: >10-15 cpm (%)
85 st129i Num 8 29i 16-30 post: 1-<2.5 cpm (%)
86 st129j Num 8 29j 16-30 post: 2.5-<3.8 cpm (%)
87 st129k Num 8 29k 16-30 post: 3.8-10 cpm (%)
88 st129l Num 8 29l 16-30 post: >10-15 cpm (%)
89 formdate Num 8 4 Form date (days since enrollment)
04:05 Friday, October 23, 2020 50
Data Set Name: tx.sas7bdat Num Variable Type Len Label
1 id Char 4 APRON Limited Use Database ID
2 tx Num 8
3 txname Char 5
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