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Developer Documentation » VDM » Adverse_Reaction_Reporting-120_85

Adverse Reaction Reporting (120.85)

This file contains all the data for an Observed Drug reaction.

Global: ^GMR(120.85,

Domain: Allergies

Properties

Label/Field Name Field # Description Datatype Attributes Range
Date/time Of Event
  date_time_of_event
.01 The date/time that this observed reaction occurred. DATE-TIME INDEXED
REQUIRED
 
Patient
  patient
.02 This field is the patient to whom this observed reaction occurred.
This field is a pointer to the Patient file.
POINTER INDEXED
REQUIRED
Patient-2
Related Reaction
  related_reaction
.03 This is the related reaction in the Patient Allergies (120.8) file for
this event.
POINTER INDEXED
REQUIRED
Patient_Allergies-120_8
Observer
  observer
.5 This field is the person who witnessed this reaction. POINTER   New_Person-200
Date Reported
  date_reported
1.1 This field is to track when a report is entered into this file. DATE-TIME INDEXED  
Reporting User
  reporting_user
1.2 This field is used to track the user who entered the reaction. It is a
pointer to File 200.
POINTER   New_Person-200
Reactions
  reactions
2 A list of signs/symptoms observed for this reaction. OBJECT   Reactions-120_8502
Suspected Agent
  suspected_agent
3 A list of suspected agents for this observed reaction. OBJECT   Suspected_Agent-120_8503
Relevant Test/lab Data
  relevant_test_lab_data
4 A list of all the relevant test/lab data for this observed reaction. OBJECT   Relevant_Test_lab_Data-120_8504
Question #1
  question_number1
5 This field indicates whether or not a patient has died from this reaction. BOOLEAN   false: n
true: y
Question #2
  question_number2
6 This field indicates whether or not a patient was treated with a RX drug
for this reaction.
BOOLEAN   false: n
true: y
Question #3
  question_number3
7 This field indicates whether or not the reaction caused a life threatening
illness.
BOOLEAN   false: n
true: y
Question #4
  question_number4
8 This field indicates whether or not the patient had to visit a doctor or
an ER because of this reaction.
BOOLEAN   false: n
true: y
Question #5
  question_number5
9 This field indicates whether this reaction required hospitalization. BOOLEAN   false: n
true: y
No. Day Hospitalized
  no_day_hospitalized
9.1 This field shows the number of days the patient was hospitalized because
of the reaction.
NUMERIC    
Question #6
  question_number6
10 This field indicates if the patient had a prolonged hospitalization
because of the reaction.
BOOLEAN   false: n
true: y
Question #7
  question_number7
11 This field indicates whether or not the patient had some sort of
permanent disability as a result of this reaction.
BOOLEAN   false: n
true: y
Question #8
  question_number8
12 This field indicates whether the patient recovered from any illness that
may have resulted from the reaction.
BOOLEAN   false: n
true: y
Question #9
  question_number9
12.1 This field is to find out if the observed reaction was a Congenital Anomaly. BOOLEAN   false: n
true: y
Question #10
  question_number10
12.2 This field is to find out if this event required any intervention. BOOLEAN   false: n
true: y
Concomitant Drugs
  concomitant_drugs
13 A list of all drugs that may have been taken at the time of the reaction. OBJECT   Concomitant_Drugs-120_8513
Other Related History
  other_related_history
14 This field contains any other related event history for this reaction. STRING    
Severity
  severity
14.5 This field indicates the severity of this reaction. ENUMERATION   MILD: 1
MODERATE: 2
SEVERE: 3
Date Md Notified
  date_md_notified
22 This field contains the date the doctor was notified of this reaction. DATE-TIME    
Fda Question #1
  fda_question_number1
23 This field determines if the reaction is considered serious. BOOLEAN   false: n
true: y
Fda Question #2
  fda_question_number2
24 This question determines whether this reaction is related to a new drug. BOOLEAN   false: n
true: y
Fda Question #3
  fda_question_number3
25 This question determines whether this reaction was an unexpected reaction
for this drug.
BOOLEAN   false: n
true: y
Fda Question #4
  fda_question_number4
26 This question determines whether this reaction is related to a
therapeutic failure of the drug.
BOOLEAN   false: n
true: y
Fda Question #5
  fda_question_number5
26.1 This field is to track if the reaction was a dose related reaction. BOOLEAN   false: n
true: y
Date Reported To Fda
  date_reported_to_fda
27 This field contains the date on which the FDA was sent the ADR report. DATE-TIME    
Date Of Patient Consent To Mfr
  date_of_patient_consent_to_mfr
28 This field is the date the patient had given his consent to have the
reaction reported to the manufacturer.
DATE-TIME    
Date Sent To Mfr
  date_sent_to_mfr
29 This is the date when the report was sent to the manufacturer. DATE-TIME    
*date Sent To Rcpm
  date_sent_to_rcpm
30 This is the date when the report was sent to the regional offices. DATE-TIME DEPRECATED  
Date Sent To Vaers
  date_sent_to_vaers
31 This field is the date when the report was sent to the VAERS. DATE-TIME    
P&t Action Fda Report
  pt_action_fda_report
31.1 This field indicates if the P&T committee determined whether to send
the report to FDA.
BOOLEAN   false: n
true: y
P&t Action Mfr Report
  pt_action_mfr_report
31.2 This field tells if the P&T committee determined whether to send the report to
the manufacturer.
BOOLEAN   false: n
true: y
*p&t Action Rcpm Report
  pt_action_rcpm_report
31.3 This field determines whether or not the P&T committee will send the
report to the regional offices.
BOOLEAN DEPRECATED  
P&t Addendum
  pt_addendum
31.5 List of comments made by the P&T committee. OBJECT   Pt_Addendum-120_85315
Reporter Name
  reporter_name
43 This field contains the name of the person filling out the reports. STRING    
Reporter Address1
  reporter_address1
44 Line one of the address of the person filling out the report. STRING    
Reporter Address2
  reporter_address2
45 Line two of the address of the person filling out the report. STRING    
Reporter Address3
  reporter_address3
46 Line three of the address of the person filling out the report. STRING    
Reporter City
  reporter_city
47 The city where the person lives who is filling out the report. STRING    
Reporter State
  reporter_state
48 The state where the reporter resides. POINTER   State-5
Reporter ZIP
  reporter_zip
49 This is the zip code of the person filling out the report. STRING    
Reporter Phone
  reporter_phone
50 This is the phone number of the person who is filling out the report. STRING    
Rpt Question #1
  rpt_question_number1
51 This field determines if the reporter is a health care provider. BOOLEAN   false: n
true: y
Rpt Question #2
  rpt_question_number2
52 This field determines if the reporter wants to permit the FDA to inform the manufacturer of his identity. BOOLEAN   false: n
true: y
Occupation
  occupation
52.1 This field contains the reporter’s current occupation. STRING    
Manufacturer Name
  manufacturer_name
53 This field is the name of the manufacturer of the reactant. STRING    
Mfr Address #1
  mfr_address_number1
54 This is address line one for the manufacturer. STRING    
Mfr Address #2
  mfr_address_number2
55 This is address line two for the manufacturer. STRING    
Mfr Address #3
  mfr_address_number3
56 This is address line three for the manufacturer. STRING    
Mfr City
  mfr_city
57 This is the city of the manufacturer. STRING    
Mfr State
  mfr_state
58 This is the state where the manufacturer is located. POINTER   State-5
Mfr ZIP
  mfr_zip
59 This is the Zip Code of the manufacturer. STRING    
Ind/nda # For Support Drug
  ind_nda_number_for_support_drug
60 This is the IND/NDA # for support drug for the manufacturer. STRING    
Mfr Control #
  mfr_control_number
61 This is the control number used by the manufacturer. STRING    
Date Received By Mfr
  date_received_by_mfr
62 This is the date the report was received by the manufacturer. DATE-TIME    
Report Source
  report_source
63 This is the source of the report. ENUMERATION   CONSUMER: c
STUDY: s
LITERATURE: l
HEALTH PROFESSIONAL: h
FOREIGN: f
15 Day Report
  _15_day_report
64 This field is to determine if the 15 Day Report has been completed. BOOLEAN   false: n
true: y
Report Type
  report_type
65 This is the type of report issued. ENUMERATION   FOLLOWUP: f
INITIAL: i

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Sub-Files

Reactions (120.8502)

ID
Reactions-120_8502

Properties

Label/Field Name Field # Description Datatype Attributes Range
Reactions
  reactions
.01 One sign/symptom observed for this reaction. POINTER INDEXED
REQUIRED
Sign_symptoms-120_83
Other Reaction
  other_reaction
1 If this sign/symptom cannot be found in the Sign/Symptoms (120.83) file,
then the free text of what the user typed in will be here, and the
signs/symptoms of OTHER REACTION will be the value of the REACTIONS field.
STRING    
Entered By
  entered_by
2 The person who entered this reaction into the system. POINTER   New_Person-200

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Suspected Agent (120.8503)

ID
Suspected_Agent-120_8503

Properties

Label/Field Name Field # Description Datatype Attributes Range
Suspected Agent
  suspected_agent
.01 This field indicates one of the suspected agents for this observed reaction. STRING INDEXED
REQUIRED
 
Daily Dose
  daily_dose
1 This field contains the daily dosage for this suspected agent. STRING    
Sig
  sig
1.5 This file contains the SIG code that indicates how this drug is to be given. STRING    
Route Of Administration
  route_of_administration
2 This is the route of administration for this suspected agent. STRING    
Indications For Use
  indications_for_use
3 This field indicates the reasoning for a particular agent. STRING    
Start Date Of Administration
  start_date_of_administration
4 This field contains the date a patient was first given the suspected agent. DATE-TIME    
Stop Date Of Administration
  stop_date_of_administration
5 This field contains the stop date for a suspected agent. DATE-TIME    
Manufacturer
  manufacturer
7 This field contains the name of the manufacturer of the suspected agent. STRING    
Lot #
  lot_number
8 This field contains the lot # for a suspected agent. STRING    
Number Of Previous Doses
  number_of_previous_doses
9 This field contains the total number of doses of this suspected agent that
were given to the patient prior to the reaction.
NUMERIC    
Last Fill Dt
  last_fill_dt
10 This field is the date that this agent was last filled. DATE-TIME    
Expiration Date
  expiration_date
10.1 This is the date that the suspected agent is to expire. DATE-TIME    
Ndc #
  ndc_number
10.2 This is the NDC (National Drug Code) of this agent. STRING    
Like Question #1
  like_question_number1
11 This question determines whether this reaction normally occurs with this reactant.
reactant.
BOOLEAN   false: n
true: y
Like Question #2
  like_question_number2
12 This question determines whether administration of the reactant was stopped. BOOLEAN   false: n
true: y
Like Question #3
  like_question_number3
13 This question determines if the reaction stopped when the administration of the reactant was terminated.
the reactant was terminated.
BOOLEAN   false: n
true: y
Like Question #4
  like_question_number4
14 This question determines whether the reactant was readministered. BOOLEAN   false: n
true: y
Like Question #5
  like_question_number5
15 This question determines whether the reaction could be due to the patient current clinical condition. BOOLEAN   false: n
true: y
Like Question #6
  like_question_number6
16 This question determines if the reaction reappeared after the reactant was readministered.
was readministered.
BOOLEAN   false: n
true: y
Likelihood
  likelihood
17 If this is an observed drug allergy/adverse reaction, then this is the
likelihood that this is an adverse reaction. The data for this field is
based on an algorithm used by the FDA.
ENUMERATION   REMOTE: 1
POSSIBLE: 2
HIGHLY PROBABLE: 4
PROBABLE: 3

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Relevant Test/lab Data (120.8504)

ID
Relevant_Test_lab_Data-120_8504

Properties

Label/Field Name Field # Description Datatype Attributes Range
Test
  test
.01 This field contains a particular test/lab data for this observed reaction. STRING INDEXED
REQUIRED
 
Results
  results
1 This field will contain the results for the particular test. STRING    
Collection D/t
  collection_d_t
2 This field is the date the sample was collected from the patient. DATE-TIME    

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Concomitant Drugs (120.8513)

ID
Concomitant_Drugs-120_8513

Properties

Label/Field Name Field # Description Datatype Attributes Range
Concomitant Drugs
  concomitant_drugs
.01 This field contains the drug(s) this patient was taking at the time
of the reaction.
STRING INDEXED
REQUIRED
 
Start Date Of Administration
  start_date_of_administration
1 This field is the date this drug was first given to the patient. DATE-TIME    
Stop Date Of Administration
  stop_date_of_administration
2 This field is the last day the patient was given this drug. DATE-TIME    
Last Fill Dt
  last_fill_dt
3 This field is the last date that this drug was filled. DATE-TIME    
Sig
  sig
4 This file contains the SIG code that indicates how this drug is to be given. STRING    

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P&t Addendum (120.85315)

ID
Pt_Addendum-120_85315

Properties

Label/Field Name Field # Description Datatype Attributes Range
Date/time Entered
  date_time_entered
.01 This is the date/time the comment was entered. DATE-TIME INDEXED
REQUIRED
 
Addendum
  addendum
1 This is the actual comment that is being added. STRING    

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Document generated on August 31st 2017, 2:55:41 pm