Alphabetized Data Dictionary TVG Database

Alphabetized Data Dictionary – TVG Database

Description / Field / Original Data Source (e.g. form, report) / Original Data Source Field / Database Form Source / Database From Source Field / Field Options
Adverse event / AdverseEvent / Adverse Event Log / Event (under Category) / Adverse Events tab → Adverse Events Data Entry Form / AdverseEvent /

Acidosis
Acne
ACTH
Acute leak syndrome
ADH
Adrenal insufficiency
Airway obstruction - Select
Alcohol intolerance syndrome
Alkaline phosphatase
Alkalosis
Allergic reaction
Alopecia
ALT
Amylase
Anorexia
Apnea
Arachnoiditis
ARDS
Artery injury - Select
Arthritis
Ascites
Aspiration
AST
Ataxia
Atelectasis
Atrophy, skin
Atrophy, subcutaneous fat
Autoimmune reaction
Bicarbonate, serum-low
Bilirubin
Bladder spasms
Blurred vision
Bone age
Bone marrow cellularity
Brachial plexopathy
Breast
Breast function
Bronchospasm
Bruising
Burn
Cardiac ischemia/infarction
Cardiopulmonary arrest
Cataract
CD4 count
Cervical spine ROM
Chelitis
Chest tube drainage or leak
Cholecystitis
Cholesterol
Chyle or lymph leakage
Chylothorax
CNS hemorrhage
CNS ischemia
CNS necrosis
Cognitive disturbance
Colitis
Colitis, infectious
Conduction abnormality - Select
Confusion
Constipation
Cough
CPK
Creatinine
CSF leak
cTnI
cTnT
Cushingoid
Cystitis
Cytokine release syndrome
Death not associated with CTCAE term - Select
Decubitus
Dehydration
Delayed puberty
Dentures
Dermal change
Dermatitis - Select
Device/prosthesis
Diabetes
Diarrhea
DIC
Diplopia
Distension
Dizziness
DL(co)
Dry eye
Dry mouth
Dry skin
Dysphagia
Dyspnea
Edema, larynx
Edema: head and neck
Edema: limb
Edema: trunk/genital
Edema: viscera
Ejaculatory dysfunction
Encephalopathy
Enteritis
Erectile dysfunction
Erythema multiforme
Esophagitis
Exostosis
Extremity-upper (function)
Eyelid dysfunction
Fatigue
Febrile neutropenia
Feminization of male
Femoral head growth
FEV(1)
Fever
Fibrinogen
Fibrosis-cosmesis
Fibrosis-deep connective tissue
Fistula, GI - Select
Fistula, GU - Select
Fistula, pulmonary - Select
Flashing lights
Flatulence
Flu-like syndrome
Flushing
Fracture
Gait/walking
Gastritis
GFR
GGT
Glaucoma
Gonadotropin
Growth hormone
Gynecomastia
Hand-foot
Haptoglobin
Hearing (monitoring program)
Hearing (without monitoring program)
Heartburn
Hematoma
Hemoglobin
Hemoglobinuria
Hemolysis
Hemorrhage pulmonary - Select
Hemorrhage with surgery
Hemorrhage, GI - Select
Hemorrhage, GU - Select
Hemorrhoids
Hiccoughs
Hot flashes
Hydrocephalus
Hypercalcemia
Hyperglycemia
Hyperkalemia
Hypermagnesemia
Hypernatremia
Hyperpigmentation
Hypertension
Hyperthyroidism
Hypertriglyceridemia
Hyperuricemia
Hypoalbuminemia
Hypocalcemia
Hypoglycemia
Hypokalemia
Hypomagnesemia
Hyponatremia
Hypoparathyroidism
Hypophosphatemia
Hypopigmentation
Hypotension
Hypothermia
Hypothyroidism
Hypoxia
Ileus
Incontinence, anal
Incontinence, urinary
Induration
Infection (documented clinically) - Select
Infection with normal ANC - Select
Infection with unknown ANC - Select
Infertility/sterility
Injection site reaction
INR
Insomnia
Intraop injury - Select
Involuntary movement
Iron overload
Irregular menses
Irritability
Joint-effusion
Joint-function
Keratitis
Kyphosis/lordosis
Laryngeal nerve
Leak, GI - Select
Leak, GU - Select
Left ventricular diastolic dysfunction
Left ventricular systolic dysfunction
Leukocytes
Leukoencephalopathy
Libido
Limb length
Lipase
Liver dysfunction
Lumbar spine ROM
Lymphedema-related fibrosis
Lymphocele
Lymphopenia
Malabsorption
Masculinization of female
Memory impairment
Mental status
Mood alteration - Select
Mucositis (clinical exam) - Select
Mucositis (functional/symptomatic) - Select
Muscle weakness - Select
Muscular/skeletal hypoplasia
Myelitis
Myelodysplasia
Myocarditis
Myositis
Nail changes
Nasal/paranasal reactions
Nausea
Necrosis, GI - Select
Neuropathy: cranial - Select
Neuropathy-motor
Neuropathy-sensory
Neutrophils
Nipple/areolar
Nyctalopia
Nystagmus
Obesity
Obstruction, GI - Select
Obstruction, GU - Select
Ocular surface disease
Opportunistic infection
Optic disc edema
Orgasmic function
Osteonecrosis
Osteoporosis
Otitis, external
Otitis, middle
Pain - Select
Palpitations
Pancreas, exocrine enzyme deficiency
Pancreatitis
Patient odor
Perforation, GI - Select
Perforation, GU - Select
Pericardial effusion
Pericarditis
Periodontal
Peripheral arterial ischemia
Personality
Petechiae
Phlebitis
Phlebolymphatic cording
Photophobia
Photosensitivity
Phrenic nerve
Platelets
Pleural effusion
Pneumonitis
Pneumothorax
Portal flow
Precocious puberty
Proctitis
Prolactin
Prolapse of stoma, GI
Prolapse stoma, GU
Prolonged intubation
Prolonged QTc
Proptosis/enophthalmos
Proteinuria
Pruritus
Psychosis
PTT
Pulmonary fibrosis
Pulmonary hypertension
Pyramidal tract dysfunction
Rash
Reduction in growth velocity
Renal failure
Restrictive cardiomyopathy
Retinal detachment
Retinoic acid syndrome
Retinopathy
Rhinitis
Right ventricular dysfunction
Rigors/chills
Salivary gland changes
Scleral necrosis
Scoliosis
Secondary Malignancy (possibly related to cancer treatment)
Seizure
Seroma
Serum sickness
Short stature
Soft tissue necrosis - Select Somnolence
Speech impairment
Splenic function
Striae
Stricture, anastomotic, GU - Select
Stricture, GI - Select
Supraventricular arrhythmia - Select
Sweating
Syncope (fainting)
Taste alteration
Teeth
Teeth development
Telangiectasia
Thrombosis/embolism ( access)
Thrombosis/thrombus/embolism
Thrombotic microangiopathy
Tinnitus
Tremor
Trismus
Tumor flare
Tumor lysis syndrome
Typhlitis
Ulcer, GI - Select Ulceration
Urinary electrolyte wasting
Urinary frequency
Urinary retention
Urine color change
Urticaria
Uveitis
Vaginal discharge
Vaginal dryness
Vaginal mucositis
Vaginal stenosis
Vaginitis
Valvular heart disease
Vasculitis
Vasovagal episode
Vein injury - Select
Ventricular arrhythmia - Select
Viral hepatitis
Visceral arterial ischemia
Vital capacity
Vitreous hemorrhage
Voice changes
Vomiting
Watery eye
Weight gain
Weight loss
Wound complication, non-infectious
Allergy - Other (Specify)
Auditory/Ear - Other (Specify)
Blood - Other (Specify)
Cardiac Arrhythmia - Other (Specify)
Cardiac General - Other (Specify)
Coagulation - Other (Specify)
Constitutional Symptoms - Other (Specify)
Dermatology - Other (Specify)
Endocrine - Other (Specify)
GI - Other (Specify)
Growth and Development - Other (Specify)
Hemorrhage - Other (Specify)
Hepatobiliary - Other (Specify)
Infection - Other (Specify)
Intra-operative Injury - Other (Specify)
Lymphatics - Other (Specify)
Metabolic/Lab - Other (Specify)
Musculoskeletal - Other (Specify)
Neurology - Other (Specify)
Ocular - Other (Specify)
Pain - Other (Specify)
Pulmonary - Other (Specify)
Renal - Other (Specify)
Sexual - Other (Specify)
Syndromes - Other (Specify)
Vascular - Other (Specify)

Adverse event attribution / AdverseEventAttribution / Adverse Event Log / Attrib / Adverse Events tab → Adverse Events Data Entry Form / Attribution / 1 = Unrelated
2 = Unlikely related
3 = Possibly related
4 = Probably related
5 = Definitely related
Adverse event category / AdverseEventCategory / Adverse Event Log / Category / Adverse Events tab → Adverse Events Data Entry Form / AdverseEventCategory /

Allergy/Immunology
Auditory/Ear
Blood/Bone marrow
Cardiac Arrhythmia
Cardiac General
Coagulation
Constitutional Symptoms
Death
Dermatology/Skin
Endocrine
Gastrointestinal
Growth and Development
Hemorrhage/Bleeding
Hepatobiliary/ Pancreas
Infection
Lymphatics
Metabolic/Laboratory
Musculoskeletal/Soft tissue
Neurology
Ocular/Visual
Pain
Pulmonary/Upper Respiratory
Renal/Genitourinary
Secondary Malignancy
Sexual/Reproductive Function
Surgery/Intra-Operative Injury
Syndromes
Vascular

Adverse event grade / AdverseEventGrade / Adverse Event Log / Grade / Adverse Events tab → Adverse Events Data Entry Form / Grade / 1 = Mild AE
2 = Moderate AE
3 = Severe AE
4 = Life-threatening/disabling AE
5 = Death related to AE
Adverse event time point / TimePoint / Adverse Event Log / Time-point / Adverse Events tab → Adverse Events Data Entry Form / Timepoint /

3 month FU
6 month FU
9 month FU
12 month FU
3 weeks after cycle 6
Chemotherapy
Cycle 1
Cycle 2
Cycle 3
Cycle 4
Cycle 5
Cycle 6
Day 7 FU
Day 14 FU
Follow Up Day 40
MO1 FU 1
MO1 Vaccine 1
MO2 FU 2
MO2 Vaccine 2
MO3 FU 3
MO3 Vaccine 3
MO4 FU 1
MO4 Vaccine 4
MO5 FU 5
MO5 Vaccine 5
MO6 FU 3
MO6 Vaccine 6
MO7 FU 1
MO7 FU 1 Month Post
MO9 FU 6
MO9 FU 3 Months Post
M10 FU 4
M12 Fu 6 Months Post
M14 FU 8
M15 Follow Up 12
M18 Follow Up 12
M18 Follow Up 12 Months Post
Other
T Cell Infusion 1
T Cell Infusion 2
T Cell Infusion 3

Alanine Aminotranferase GPT / SGPT / Lab report / Alanine Aminotranferase_GPT / Hematology → Blood Chemistry Data Entry Form / SGPT / Number entry
Albumin / Albumin / Lab report / Albumin / Hematology → Blood Chemistry Data Entry Form / Albumin / Number entry
Alkaline Phosphatase / Alk Phos / Lab report / Alkaline Phosphatase (Total) / Hematology → Blood Chemistry Data Entry Form / Alk Phos / Number entry
All Sites of Initial Relapse – Bone / IRBone / Breast Cancer History form / All sites of past disease → Bone / Patient Information → Medical History / Bone /

All Sites of Initial Relapse – Brain / IRBrain / Breast Cancer History form / All sites of past disease → Brain / Patient Information → Medical History / Brain /

All Sites of Initial Relapse – Liver / IRLiver / Breast Cancer History form / All sites of past disease → Liver / Patient Information → Medical History / Liver /

All Sites of Initial Relapse – Lung / IRLung / Breast Cancer History form / All sites of past disease → Lung / Patient Information → Medical History / Lung /

All Sites of Initial Relapse - Other / IROther / Breast Cancer History form / All sites of past disease → Other / Patient Information → Medical History / Other /

All Sites of Initial Relapse - Other / IROtherText / Breast Cancer History form / All sites of past disease → Other / Patient Information → Medical History / ? / Text entry
All Sites of Initial Relapse – Skin / IRSkin / Breast Cancer History form / All sites of past disease → Skin / Patient Information → Medical History / Skin /

All Sites of Present Disease – Bone / PDBone / Breast Cancer History form / All sites of present disease → Bone / Patient Information → Medical History / Bone /

All Sites of Present Disease – Brain / PDBrain / Breast Cancer History form / All sites of present disease → Brain / Patient Information → Medical History / Brain /

All Sites of Present Disease – Liver / PDLiver / Breast Cancer History form / All sites of present disease → Liver / Patient Information → Medical History / Liver /

All Sites of Present Disease – Lung / PDLung / Breast Cancer History form / All sites of present disease → Lung / Patient Information → Medical History / Lung /

All Sites of Present Disease - Other / PDOther / Breast Cancer History form / All sites of present disease → Other / Patient Information → Medical History / Other /

All Sites of Present Disease - Other / PDOtherText / Breast Cancer History form / All sites of present disease → Other / Patient Information → Medical History / ? / Text entry
All Sites of Present Disease – Skin / PDSkin / Breast Cancer History form / All sites of present disease → Skin / Patient Information → Medical History / Skin /

Allergy Date / AllergyDate / Breast Cancer History form, / Allergy Date / Patient Information → Medical History / Allergy Date / Date of allergy in format mm/dd/yyyy
Anti Nuclear Abs - Pos/Neg or ratio (1:40, 1:80) / ANA / Lab report / ANA Pattern / Hematology → Blood Chemistry Data Entry Form / ANA /

Negative
1:40
1:80

Antibody / AB / ? / ? / NA / NA / Text entry
Anti-dsDNA / AntidsDNA / Lab report / Anti dsDNA, by EIA / Hematology → Blood Chemistry Data Entry Form / AntidsDNA / Number entry
Antinausea meds used / Antinausea meds used / Breast Cancer History Form / Antinausea Medications → Specify / Patient Information → Treatments / Specify / Text entry
Antinausea meds used during chemotherapy / AntinauseaMeds / Breast Cancer History Form / Antinausea Medications / Patient Information → Treatments / Antinausea Meds /

Arm of study / Arm / Moved from from patient demographics table (per study info) / Various / UPN Information / Arm / Text entry
Ascites / ascites / ? / ? / Specimen Data Entry Form / Ascites /

Aspartate Aminotransferase GOT / SGOT / Lab report / Aspartate Aminotransferase_GOT / Hematology → Blood Chemistry Data Entry Form / SGOT / Number entry
Basophils / Baso / Lab report / Basophils / Hematology → Blood Chemistry Data Entry Form / Baso / Number entry
Bilirubin / bili / Lab report / Bilirubin (Total) / Hematology → Blood Chemistry Data Entry Form / bili / Number entry
Biologic Agents received / BiologicAgents / Breast Cancer History Form / Biologic Agent / Patient Information → Treatments /

Biopsy / biopsy / ? / ? / Specimen Data Entry Form / Biopsy /

Blood collected / blood / ? / ? / Specimen Data Entry Form / Blood /

Blood consent / Blood / Specimen Repository Informed Consent form / Permission for blood / Patient Information → Contact Track → Patient Contact Tracking → Consent / Repository → Blood /

CA-125 / CA-125 / Lab report / CA-125 / Hematology → Blood Chemistry Data Entry Form / CA-125 / Number entry
CA-15.3 / CA-15-3 / Lab report / CA-15-3 / Hematology → Blood Chemistry Data Entry Form / CA-15.3 / Number entry
CA-27.29 / CA-27-29 / Lab report / CA-27-29 / Hematology → Blood Chemistry Data Entry Form / CA-27.29 / Number entry
Calcium / Ca / Lab report / Calcium / Hematology → Blood Chemistry Data Entry Form / Ca / Number entry
Cancer diagnosis type / Cancer / Breast Cancer History form, Eligibility Checklist / Circumstances of diagnosis (BCHF), noted on EC in box #1 / Patient Information → Medical History / Diagnosis /

Breast
Colon
Lung
Melanoma
Ovarian
Prostate

Cancer stage at diagnosis / DiseaseStageDiag / Breast Cancer History form / Stage at Diagnosis / Patient Information → Medical History / Stage at Diagnosis / Text entry
Cancer stage at enrollment / DiseaseStageEnroll / Breast Cancer History form, Eligibility Checklist, physician notes / Stage at Enrollment (BCHF), noted on EC in box #1, or in physician notes / Patient Information → Medical History / Stage at Enrollement / Text entry
Cancer stage at recurrence / DiseaseStageRecurr / Breast Cancer History form / Stage at Recurrence / Patient Information → Medical History / Stage at Recurrence / Text entry
Cause of patient’s death / DeathCause / ? / ? / Patient Information → Patient Info / Death Cause / Text entry
CEA / CEA / Lab report / CEA / Hematology → Blood Chemistry Data Entry Form / CEA / Number entry
Chloride / Cl / Lab report / Chloride / Hematology → Blood Chemistry Data Entry Form / Cl / Number entry
CMV lysate positive wells / CMV / ? / ? / Proliferation Assay Data Entry Form / Pos Wells → CMV / Number entry
CMV Precursors/million cells / CMV-ppm / ? / ? / Elispot Assay Entry / PPM → CMV / Number entry
CMV SI / CMV-si / ? / ? / Proliferation Assay Data Entry Form / SI → CMV / Number entry
CMV spots per well / CMV / ? / ? / Elispot Assay Entry / #SPW → CMV / Number entry
CMV- standard error of spots/well / CMV-SEM / ? / ? / Elispot Assay Entry / SEM → CMV / Number entry
Comments – AE’s / Comments / Adverse Event Log / Adverse Event / Adverse Events tab → Adverse Events Data Entry Form / Comments / Text entry (or choices for Pain category)
Comments – Elispot Assay Entry / Comments / ? / ? / Elispot Assay Entry / Comments / Text entry
Comments – Cardiac History / Comment / Imaging/Cardiac History form / Various / Patient Information → Cardiac → Patient Cardiac Results → MUGA, ECHO, or EKG tabs / Comments / Text entry
Comments - Imaging / Comments / Imaging/Cardiac History form / CT Scan/MRI → Comments; PET Scan→ Comments; Bone Scan → Comments; X-Ray → Comments; Mammaogram/Ultrasound → Comments / Patient Information → Imaging → Patient Imaging Results → CT Scan/MRI; Patient Imaging Results → PET Scan; Patient Imaging Results → Bone Scan; Patient Imaging Results → X Ray; Patient Imaging Results → Mammogram/Ultrasound / Comments / Text entry
Comments – Patient Information / Comments / Patient Information Form / Comments / Patient Information / Comments / Text entry
Comments – Proliferation Assay / comments / ? / ? / Proliferation Assay Data Entry Form / Comments / Text entry
Comments - Surgery / Comment / Breast Cancer History form / Treatment History → Surgery → Comments / Patient Information → Treatments → Surgery / Comment / Text entry
Compliment C3 / C3 / Lab report / Complement C3 / Hematology → Blood Chemistry Data Entry Form / C3 / Number entry
Concurrent use of AI’s / AIConcurrent / Breast Cancer History Form / Hormone Therapy → AI → Current / Patient Information → Treatments / Concurrent /

Concurrent use of biologic agent / BiologicConcurrent / Breast Cancer History Form / Biologic Agent → Current / Patient Information → Treatments / Concurrent /

Concurrent use of bisphosphonates / BisphConcurrent / Breast Cancer History Form / Bisphosphonates → Current / Patient Information → Treatments / Concurrent /

Concurrent use of HDE’s / HDEConcurrent / Breast Cancer History Form / Hormone Therapy → HDE → Current / Patient Information → Treatments / Concurrent /

Concurrent use of other hormones / OtherConcurrent / Breast Cancer History Form / Hormone Therapy → Other → Current / Patient Information → Treatments / Concurrent /

Concurrent use of SERMS / SERMSConcurrent / Breast Cancer History Form / Hormone Therapy → SERMS → Current / Patient Information → Treatments / Concurrent /

Consent signer if other than patient / ConsentSigner / Consent form / Signed by if other than patient / Patient Information → Contact Track → Patient Contact Tracking → Consent / Signed By / Text entry
Contact event method / ContactMethod / ? / ? / Patient Information → Contact Track → Patient Contact Tracking → Initial Screening / How Contacted /

Mail
In Person
Phone
Email
Other

Contact with patient date / Date / Form date / Various / Patient Information → Contact Track → Patient Contact Tracking / Screen Date or Date – depending on tab / Date of patient contact in format mm/dd/yyyy
Contact with patient type / EventType / Form name / Various / Patient Information → Contact Track → Patient Contact Tracking / Choose appropriate tab:

Initial Screening
Follow Up
Clinic Visit
Eligibility Checklist
Screen – do not use
Packet sent – do not use
Packet Received – do not use
Study Enrollment
Informed Consent
Off Study
Audit
Misc.
Biopsy

Initial Screening
Follow Up
Clinic Visit
Eligibility Checklist
Screen – do not use
Packet sent – do not use
Packet Received – do not use
Study Enrollment
Informed Consent
Off Study
Audit
Misc.
Biopsy

Copy given to patient / CopyMethod / Consent form / Copy to patient / Patient Information → Contact Track → Patient Contact Tracking → Consent / Copy to Pt /

In Person
Mail
No

Creatinine / creatin / Lab report / Creatinine / Hematology → Blood Chemistry Data Entry Form / Creatinine / Number entry
Current Menopausal Status / MenoStatCurrent / Breast Cancer History form / Current menopausal status / Patient Information → Medical History / Current /

pre
post (surgical)
post (natural)
post (GNRH agonist)
post (chemo)

Date AE ended / DateEnded / Adverse Event Log / Stop Date / Adverse Events tab → Adverse Events Data Entry Form / Ended / Date AE ended in format mm/dd/yyyy
Date AE started / DateStarted / Adverse Event Log / Start Date / Adverse Events tab → Adverse Events Data Entry Form / Started / Date AE started in format mm/dd/yyyy
Date began study / Datebegin / Consent forms / Consent date / UPN Information / Begin Date / Date patient began study in format mm/dd/yyyy
Date information packet sent / PacketSentDate / ? / ? / Patient Information → Contact Track → Patient Contact Tracking → Initial Screening / Packet Sent Date / Date information packet sent in format mm/dd/yyyy
Date of assay / AssayDate / ? / ? / Elispot Assay Entry / Assay Date / Text entry
Date of assay set-up / AssayDate / ? / ? / Proliferation Assay Data Entry Form / Assay Date / Text entry
Date of blood draw / BloodDrawDate / Lab report / Date collected / Hematology → Blood Chemistry Data Entry Form / Draw Date / Date of blood draw in format mm/dd/yyyy