analysis/schemas/report_fields_table.html


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<title>BioDEX Report Fields</title>
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<div class="title">BioDEX Report Fields</div>
<table border="1" class="dataframe">
  <thead>
    <tr style="text-align: right;">
      <th>fields</th>
      <th>description</th>
      <th>values</th>
    </tr>
  </thead>
  <tbody>
    <tr>
      <td>authoritynumb</td>
      <td>Populated with the Regulatory Authority’s case report number, when available.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>companynumb</td>
      <td>Identifier for the company providing the report. This is self-assigned.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>duplicate</td>
      <td>This value is `1` if earlier versions of this report were submitted to FDA. openFDA only shows the most recent version.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>fulfillexpeditecriteria</td>
      <td>Identifies expedited reports (those that were processed within 15 days).</td>
      <td>1: True, 2: False</td>
    </tr>
    <tr>
      <td>occurcountry</td>
      <td>The name of the country where the event occurred.</td>
      <td>name: Country codes, link: http://data.okfn.org/data/core/country-list</td>
    </tr>
    <tr>
      <td>patient.drug.items.actiondrug</td>
      <td>Actions taken with the drug.</td>
      <td>1: Drug withdrawn, 2: Dose reduced, 3: Dose increased, 4: Dose not changed, 5: Unknown, 6: Not applicable</td>
    </tr>
    <tr>
      <td>patient.drug.items.activesubstance.activesubstancename</td>
      <td>Product active ingredient, which may be different than other drug identifiers (when provided).</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugadditional</td>
      <td>Dechallenge outcome information—whether the event abated after product use stopped or the dose was reduced. Only present when this was attempted and the data was provided.</td>
      <td>1: Yes, 2: No, 3: Does not apply</td>
    </tr>
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      <td>patient.drug.items.drugadministrationroute</td>
      <td>The drug’s route of administration.</td>
      <td>001: Auricular (otic), 002: Buccal, 003: Cutaneous, 004: Dental, 005: Endocervical, 006: Endosinusial, 007: Endotracheal, 008: Epidural, 009: Extra-amniotic, 010: Hemodialysis, 011: Intra corpus cavernosum, 012: Intra-amniotic, 013: Intra-arterial, 014: Intra-articular, 015: Intra-uterine, 016: Intracardiac, 017: Intracavernous, 018: Intracerebral, 019: Intracervical, 020: Intracisternal, 021: Intracorneal, 022: Intracoronary, 023: Intradermal, 024: Intradiscal (intraspinal), 025: Intrahepatic, 026: Intralesional, 027: Intralymphatic, 028: Intramedullar (bone marrow), 029: Intrameningeal, 030: Intramuscular, 031: Intraocular, 032: Intrapericardial, 033: Intraperitoneal, 034: Intrapleural, 035: Intrasynovial, 036: Intratumor, 037: Intrathecal, 038: Intrathoracic, 039: Intratracheal, 040: Intravenous bolus, 041: Intravenous drip, 042: Intravenous (not otherwise specified), 043: Intravesical, 044: Iontophoresis, 045: Nasal, 046: Occlusive dressing technique, 047: Ophthalmic, 048: Oral, 049: Oropharingeal, 050: Other, 051: Parenteral, 052: Periarticular, 053: Perineural, 054: Rectal, 055: Respiratory (inhalation), 056: Retrobulbar, 057: Sunconjunctival, 058: Subcutaneous, 059: Subdermal, 060: Sublingual, 061: Topical, 062: Transdermal, 063: Transmammary, 064: Transplacental, 065: Unknown, 066: Urethral, 067: Vaginal</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugauthorizationnumb</td>
      <td>Drug authorization or application number (NDA or ANDA), if provided.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugbatchnumb</td>
      <td>Drug product lot number, if provided.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugcharacterization</td>
      <td>Reported role of the drug in the adverse event report. These values are not validated by FDA.</td>
      <td>1: Suspect (the drug was considered by the reporter to be the cause), 2: Concomitant (the drug was reported as being taken along with the suspect drug), 3: Interacting (the drug was considered by the reporter to have interacted with the suspect drug)</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugcumulativedosagenumb</td>
      <td>The cumulative dose taken until the first reaction was experienced, if provided.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugcumulativedosageunit</td>
      <td>The unit for `drugcumulativedosagenumb`.</td>
      <td>001: kg (kilograms), 002: g (grams), 003: mg (milligrams), 004: µg (micrograms)</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugdosageform</td>
      <td>The drug’s dosage form. There is no standard, but values may include terms like `tablet` or `solution for injection`.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugdosagetext</td>
      <td>Additional detail about the dosage taken. Frequently unknown, but occasionally including information like a brief textual description of the schedule of administration.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugenddate</td>
      <td>Date the patient stopped taking the drug.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugenddateformat</td>
      <td>Encoding format of the field `drugenddateformat`. Always set to `102` (YYYYMMDD).</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugindication</td>
      <td>Indication for the drug’s use.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugintervaldosagedefinition</td>
      <td>The unit for the interval in the field `drugintervaldosageunitnumb.`</td>
      <td>801: Year, 802: Month, 803: Week, 804: Day, 805: Hour, 806: Minute, 807: Trimester, 810: Cyclical, 811: Trimester, 812: As necessary, 813: Total</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugintervaldosageunitnumb</td>
      <td>Number of units in the field `drugintervaldosagedefinition`.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugrecurreadministration</td>
      <td>Whether the reaction occured after readministration of the drug.</td>
      <td>1: Yes, 2: No, 3: Unknown</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugrecurrence.drugrecuraction</td>
      <td>Populated with the Reaction/Event information if/when `drugrecurreadministration` equals `1`.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugrecurrence.drugrecuractionmeddraversion</td>
      <td>The version of MedDRA from which the term in `drugrecuraction` is drawn.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugseparatedosagenumb</td>
      <td>The number of separate doses that were administered.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugstartdate</td>
      <td>Date the patient began taking the drug.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugstartdateformat</td>
      <td>Encoding format of the field `drugstartdate`. Always set to `102` (YYYYMMDD).</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugstructuredosagenumb</td>
      <td>The number portion of a dosage; when combined with `drugstructuredosageunit` the complete dosage information is represented. For example, *300* in `300 mg`.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugstructuredosageunit</td>
      <td>The unit for the field `drugstructuredosagenumb`. For example, *mg* in `300 mg`.</td>
      <td>001: kg (kilograms), 002: g (grams), 003: mg (milligrams), 004: µg (micrograms)</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugtreatmentduration</td>
      <td>The interval of the field `drugtreatmentdurationunit` for which the patient was taking the drug.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.drug.items.drugtreatmentdurationunit</td>
      <td>None</td>
      <td>801: Year, 802: Month, 803: Week, 804: Day, 805: Hour, 806: Minute</td>
    </tr>
    <tr>
      <td>patient.drug.items.medicinalproduct</td>
      <td>Drug name. This may be the valid trade name of the product (such as `ADVIL` or `ALEVE`) or the generic name (such as `IBUPROFEN`). This field is not systematically normalized. It may contain misspellings or idiosyncratic descriptions of drugs, such as combination products such as those used for birth control.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.patientagegroup</td>
      <td>Populated with Patient Age Group code.</td>
      <td>1: Neonate, 2: Infant, 3: Child, 4: Adolescent, 5: Adult, 6: Elderly</td>
    </tr>
    <tr>
      <td>patient.patientdeath.patientdeathdate</td>
      <td>If the patient died, the date that the patient died.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.patientdeath.patientdeathdateformat</td>
      <td>Encoding format of the field `patientdeathdate`. Always set to `102` (YYYYMMDD).</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.patientonsetage</td>
      <td>Age of the patient when the event first occured.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.patientonsetageunit</td>
      <td>The unit for the interval in the field `patientonsetage.`</td>
      <td>800: Decade, 801: Year, 802: Month, 803: Week, 804: Day, 805: Hour</td>
    </tr>
    <tr>
      <td>patient.patientsex</td>
      <td>The sex of the patient.</td>
      <td>0: Unknown, 1: Male, 2: Female</td>
    </tr>
    <tr>
      <td>patient.patientweight</td>
      <td>The patient weight, in kg (kilograms).</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.reaction.items.reactionmeddrapt</td>
      <td>Patient reaction, as a MedDRA term. Note that these terms are encoded in British English. For instance, diarrhea is spelled `diarrohea`. MedDRA is a standardized medical terminology.</td>
      <td>name: MedDRA, link: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162038.htm</td>
    </tr>
    <tr>
      <td>patient.reaction.items.reactionmeddraversionpt</td>
      <td>The version of MedDRA from which the term in `reactionmeddrapt` is drawn.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>patient.reaction.items.reactionoutcome</td>
      <td>Outcome of the reaction in `reactionmeddrapt` at the time of last observation.</td>
      <td>1: Recovered/resolved, 2: Recovering/resolving, 3: Not recovered/not resolved, 4: Recovered/resolved with sequelae (consequent health issues), 5: Fatal, 6: Unknown</td>
    </tr>
    <tr>
      <td>patient.summary.narrativeincludeclinical</td>
      <td>Populated with Case Event Date, when available; does `NOT` include Case Narrative.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>primarysource.literaturereference</td>
      <td>Populated with the Literature Reference information, when available.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>primarysource.qualification</td>
      <td>Category of individual who submitted the report.</td>
      <td>1: Physician, 2: Pharmacist, 3: Other health professional, 4: Lawyer, 5: Consumer or non-health professional</td>
    </tr>
    <tr>
      <td>primarysource.reportercountry</td>
      <td>Country from which the report was submitted.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>primarysourcecountry</td>
      <td>Country of the reporter of the event.</td>
      <td>name: Country codes, link: http://data.okfn.org/data/core/country-list</td>
    </tr>
    <tr>
      <td>receiptdate</td>
      <td>Date that the _most recent_ information in the report was received by FDA.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>receiptdateformat</td>
      <td>Encoding format of the `transmissiondate` field. Always set to 102 (YYYYMMDD).</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>receivedate</td>
      <td>Date that the report was _first_ received by FDA. If this report has multiple versions, this will be the date the first version was received by FDA.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>receivedateformat</td>
      <td>Encoding format of the `transmissiondate` field. Always set to 102 (YYYYMMDD).</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>receiver.receiverorganization</td>
      <td>Name of the organization receiving the report. Because FDA received the report, the value is always `FDA`.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>receiver.receivertype</td>
      <td>The type of organization receiving the report. The value,`6`, is only specified if it is `other`, otherwise it is left blank.</td>
      <td>6: Other</td>
    </tr>
    <tr>
      <td>reportduplicate.duplicatenumb</td>
      <td>The case identifier for the duplicate.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>reportduplicate.duplicatesource</td>
      <td>The name of the organization providing the duplicate.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>reporttype</td>
      <td>Code indicating the circumstances under which the report was generated.</td>
      <td>1: Spontaneous, 2: Report from study, 3: Other, 4: Not available to sender (unknown)</td>
    </tr>
    <tr>
      <td>safetyreportid</td>
      <td>The 8-digit Safety Report ID number, also known as the case report number or case ID. The first 7 digits (before the hyphen) identify an individual report and the last digit (after the hyphen) is a checksum. This field can be used to identify or find a specific adverse event report.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>safetyreportversion</td>
      <td>The version number of the `safetyreportid`. Multiple versions of the same report may exist, it is generally best to only count the latest report and disregard others. openFDA will only return the latest version of a report.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>sender.senderorganization</td>
      <td>Name of the organization sending the report. Because FDA is providing these reports to you, the value is always `FDA-Public Use.`</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>sender.sendertype</td>
      <td>The name of the organization sending the report. Because FDA is providing these reports to you, the value is always `2`.</td>
      <td>2: Regulatory authority</td>
    </tr>
    <tr>
      <td>serious</td>
      <td>Seriousness of the adverse event.</td>
      <td>1: The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition, 2: The adverse event did not result in any of the above</td>
    </tr>
    <tr>
      <td>seriousnesscongenitalanomali</td>
      <td>This value is `1` if the adverse event resulted in a congenital anomaly, and absent otherwise.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>seriousnessdeath</td>
      <td>This value is `1` if the adverse event resulted in death, and absent otherwise.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>seriousnessdisabling</td>
      <td>This value is `1` if the adverse event resulted in disability, and absent otherwise.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>seriousnesshospitalization</td>
      <td>This value is `1` if the adverse event resulted in a hospitalization, and absent otherwise.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>seriousnesslifethreatening</td>
      <td>This value is `1` if the adverse event resulted in a life threatening condition, and absent otherwise.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>seriousnessother</td>
      <td>This value is `1` if the adverse event resulted in some other serious condition, and absent otherwise.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>transmissiondate</td>
      <td>Date that the record was created. This may be earlier than the date the record was received by the FDA.</td>
      <td>Undefined</td>
    </tr>
    <tr>
      <td>transmissiondateformat</td>
      <td>Encoding format of the `transmissiondate` field. Always set to 102 (YYYYMMDD).</td>
      <td>Undefined</td>
    </tr>
  </tbody>
</table>
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