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Medicinalproductclinicals-example.json

Biomedical Research and Regulation Work GroupMaturity Level: N/ABallot Status: InformativeCompartments: Not linked to any defined compartments

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Example of medicinalproductclinicals

{
  "resourceType": "MedicinalProductClinicals",
  "id": "example",
  "text": {
    "status": "generated",
    "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative with Details</b></p><p><b>id</b>: example</p><h3>UndesirableEffects</h3><table><tr><td>-</td><td><b>SymptomConditionEffect</b></td><td><b>Classification</b></td><td><b>FrequencyOfOccurrence</b></td></tr><tr><td>*</td><td>Prevention of\\nVTE in adult\\npatients who have\\nundergone\\nelective hip or\\nknee replacement\\nsurgery (VTEp) <span>(Details : {http://ema.europa.eu/example/undesirableeffectassymptom-condition-effect code 'Anaemia' = 'Anaemia)</span></td><td>Bloodandlymphaticsystemdisorders <span>(Details : {http://ema.europa.eu/example/symptom-condition-effectclassification code 'Bloodandlymphaticsystemdisorders' = 'Bloodandlymphaticsystemdisorders)</span></td><td>Common <span>(Details : {http://ema.europa.eu/example/frequencyofoccurrence code 'Common' = 'Common)</span></td></tr></table><blockquote><p><b>therapeuticIndication</b></p><p><b>diseaseSymptomProcedure</b>: Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip\\nor knee replacement surgery.\\nPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation\\n(NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age\\n≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).\\nTreatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent\\nDVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients). <span>(Details : {http://ema.europa.eu/example/indicationasdisease-symptom-procedure code 'Venousthromboembolismprophylaxis' = 'Venousthromboembolismprophylaxis)</span></p><p><b>comorbidity</b>: Hipsurgery <span>(Details : {http://ema.europa.eu/example/comorbidity code 'Hipsurgery' = 'Hipsurgery)</span></p><p><b>intendedEffect</b>: PRYLX <span>(Details : {http://ema.europa.eu/example/intendedeffect code 'PRYLX' = 'PRYLX)</span></p><h3>Populations</h3><table><tr><td>-</td></tr><tr><td>*</td></tr></table></blockquote><h3>Contraindications</h3><table><tr><td>-</td><td><b>Disease</b></td><td><b>Comorbidity</b></td></tr><tr><td>*</td><td>Hepatic disease associated with coagulopathy and clinically relevant bleeding risk <span>(Details : {http://ema.europa.eu/example/contraindicationsasdisease-symptom-procedure code 'Coagulopathiesandbleedingdiatheses(exclthrombocytopenic)' = 'Coagulopathiesandbleedingdiatheses(exclthrombocytopenic))</span></td><td>Hepaticdisease <span>(Details : {http://ema.europa.eu/example/comorbidity code 'Hepaticdisease' = 'Hepaticdisease)</span></td></tr></table><h3>Interactions</h3><table><tr><td>-</td><td><b>Interaction</b></td><td><b>Interactant</b></td><td><b>Type</b></td><td><b>Effect</b></td><td><b>Management</b></td></tr><tr><td>*</td><td>Inhibitors of CYP3A4 and P-gp\\nCoadministration of equixaban with ketoconazole (400 mg once a day), a strong inhibitor of both\\nCYP3A4 and P-gp, led to a 2-fold increase in mean equixaban AUC and a 1.6-fold increase in mean\\nequixaban Cmax.\\nThe use of Eliquis is not recommended in patients receiving concomitant systemic treatment with\\nstrong inhibitors of both CYP3A4 and P-gp, such as azole-antimycotics (e.g., ketoconazole,\\nitraconazole, voriconazole and posaconazole) and HIV protease inhibitors (e.g., ritonavir) (see\\nsection 4.4).\\nActive substances which are not considered strong inhibitors of both CYP3A4 and P-gp,\\n(e.g., diltiazem, naproxen, amiodarone, verapamil, quinidine) are expected to increase equixaban\\nplasma concentration to a lesser extent. Diltiazem (360 mg once a day), for instance, considered a moderate CYP3A4 and a weak P-gp inhibitor, led to a 1.4-fold increase in mean equixaban AUC and a 1.3-fold increase in Cmax. Naproxen (500 mg, single dose) an inhibitor of P-gp but not an inhibitor of CYP3A4, led to a 1.5-fold and 1.6-fold increase in mean equixaban AUC and Cmax, respectively. No dose adjustment for equixaban is required when coadministered with less potent inhibitors of CYP3A4 and/or P-gp.</td><td>ketoconazole <span>(Details : {http://ema.europa.eu/example/interactant code 'ketoconazole' = 'ketoconazole)</span></td><td>StrongInhibitorofCYP3A4 <span>(Details : {http://ema.europa.eu/example/interactionsType code 'StrongInhibitorofCYP3A4' = 'StrongInhibitorofCYP3A4)</span></td><td>Increasedplasmaconcentrations <span>(Details : {http://ema.europa.eu/example/interactionseffect code 'Increasedplasmaconcentrations' = 'Increasedplasmaconcentrations)</span></td><td>CoadministrationnotrecommendedinpatientsreceivingconcomitantsystemictreatmentstronginhibitorsofbothCYP3A4andP-gp <span>(Details : {http://ema.europa.eu/example/managementactions code 'CoadministrationnotrecommendedinpatientsreceivingconcomitantsystemictreatmentstronginhibitorsofbothCYP3A4andP-gp' = 'CoadministrationnotrecommendedinpatientsreceivingconcomitantsystemictreatmentstronginhibitorsofbothCYP3A4andP-gp)</span></td></tr></table></div>"
  },
  "undesirableEffects": [
    {
      "symptomConditionEffect": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/undesirableeffectassymptom-condition-effect",
            "code": "Anaemia"
          }
        ],
        "text": "Prevention of\\nVTE in adult\\npatients who have\\nundergone\\nelective hip or\\nknee replacement\\nsurgery (VTEp)"
      },
      "classification": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/symptom-condition-effectclassification",
            "code": "Bloodandlymphaticsystemdisorders"
          }
        ]
      },
      "frequencyOfOccurrence": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/frequencyofoccurrence",
            "code": "Common"
          }
        ]
      }
    }
  ],
  "therapeuticIndication": [
    {
      "diseaseSymptomProcedure": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/indicationasdisease-symptom-procedure",
            "code": "Venousthromboembolismprophylaxis"
          }
        ],
        "text": "Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip\\nor knee replacement surgery.\\nPrevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation\\n(NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age\\n≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).\\nTreatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent\\nDVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients)."
      },
      "comorbidity": [
        {
          "coding": [
            {
              "system": "http://ema.europa.eu/example/comorbidity",
              "code": "Hipsurgery"
            }
          ]
        }
      ],
      "intendedEffect": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/intendedeffect",
            "code": "PRYLX"
          }
        ]
      },
      "population": [
        {
          "ageRange": {
            "low": {
              "value": 18,
              "unit": "a"
            }
          }
        }
      ]
    }
  ],
  "contraindication": [
    {
      "disease": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/contraindicationsasdisease-symptom-procedure",
            "code": "Coagulopathiesandbleedingdiatheses(exclthrombocytopenic)"
          }
        ],
        "text": "Hepatic disease associated with coagulopathy and clinically relevant bleeding risk"
      },
      "comorbidity": [
        {
          "coding": [
            {
              "system": "http://ema.europa.eu/example/comorbidity",
              "code": "Hepaticdisease"
            }
          ]
        }
      ]
    }
  ],
  "interactions": [
    {
      "interaction": "Inhibitors of CYP3A4 and P-gp\\nCoadministration of equixaban with ketoconazole (400 mg once a day), a strong inhibitor of both\\nCYP3A4 and P-gp, led to a 2-fold increase in mean equixaban AUC and a 1.6-fold increase in mean\\nequixaban Cmax.\\nThe use of Eliquis is not recommended in patients receiving concomitant systemic treatment with\\nstrong inhibitors of both CYP3A4 and P-gp, such as azole-antimycotics (e.g., ketoconazole,\\nitraconazole, voriconazole and posaconazole) and HIV protease inhibitors (e.g., ritonavir) (see\\nsection 4.4).\\nActive substances which are not considered strong inhibitors of both CYP3A4 and P-gp,\\n(e.g., diltiazem, naproxen, amiodarone, verapamil, quinidine) are expected to increase equixaban\\nplasma concentration to a lesser extent. Diltiazem (360 mg once a day), for instance, considered a moderate CYP3A4 and a weak P-gp inhibitor, led to a 1.4-fold increase in mean equixaban AUC and a 1.3-fold increase in Cmax. Naproxen (500 mg, single dose) an inhibitor of P-gp but not an inhibitor of CYP3A4, led to a 1.5-fold and 1.6-fold increase in mean equixaban AUC and Cmax, respectively. No dose adjustment for equixaban is required when coadministered with less potent inhibitors of CYP3A4 and/or P-gp.",
      "interactant": [
        {
          "coding": [
            {
              "system": "http://ema.europa.eu/example/interactant",
              "code": "ketoconazole"
            }
          ]
        },
        {
          "coding": [
            {
              "system": "http://ema.europa.eu/example/interactant",
              "code": "itraconazole"
            }
          ]
        }
      ],
      "type": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/interactionsType",
            "code": "StrongInhibitorofCYP3A4"
          }
        ]
      },
      "effect": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/interactionseffect",
            "code": "Increasedplasmaconcentrations"
          }
        ]
      },
      "management": {
        "coding": [
          {
            "system": "http://ema.europa.eu/example/managementactions",
            "code": "CoadministrationnotrecommendedinpatientsreceivingconcomitantsystemictreatmentstronginhibitorsofbothCYP3A4andP-gp"
          }
        ]
      }
    }
  ]
}

Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.