FHIR IG analytics

Resources that use this resource

No resources found

Resources that this resource uses

No resources found

Narrative

Note: links and images are rebased to the (stated) source

Source1

{
  "resourceType": "Composition",
  "id": "370512",
  "meta": {
    "versionId": "10",
    "lastUpdated": "2025-10-21T11:07:38.408Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-report"
    ]
  },
  "language": "en",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "contained": [
    {
      "resourceType": "Group",
      "id": "ScreenedGroup",
      "name": "Group Screened for Participation for QUARTET USA Trial",
      "description": "Potentially eligible patients screened for participation in the QUARTET USA Trial",
      "type": "person",
      "membership": "enumerated",
      "quantity": 120
    },
    {
      "resourceType": "Group",
      "id": "FG000",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/comparator-group",
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-group",
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/study-group"
        ]
      },
      "name": "NCT03640312 Flow Group QUARTET LDQT",
      "description": "Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States.\n\nQUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.",
      "type": "person",
      "membership": "enumerated",
      "quantity": 32,
      "characteristic": [
        {
          "code": {
            "text": "Research Study from which this is a flow group"
          },
          "valueReference": {
            "display": "NCT03640312"
          },
          "exclude": false
        }
      ]
    },
    {
      "resourceType": "Group",
      "id": "FG001",
      "name": "NCT03640312 Flow Group Candesartan",
      "description": "Patients randomized to the comparison arm took a once daily 8mg candesartan.\n\nCandesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.",
      "type": "person",
      "membership": "enumerated",
      "quantity": 30,
      "characteristic": [
        {
          "code": {
            "text": "Research Study from which this is a flow group"
          },
          "valueReference": {
            "display": "NCT03640312"
          },
          "exclude": false
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "ExcludedCount",
      "title": "Excluded from QUARTET USA Trial",
      "status": "active",
      "variableDefinition": [
        {
          "description": "Screened for Participation",
          "variableRole": "population",
          "observed": {
            "reference": "#ScreenedGroup",
            "type": "Group",
            "display": "Screened for Participation"
          }
        },
        {
          "description": "Excluded",
          "variableRole": "outcome",
          "observed": {
            "type": "EvidenceVariable",
            "display": "Excluded"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "count"
              }
            ]
          },
          "quantity": {
            "value": 58
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "ReasonsForExclusion",
      "title": "Reasons for exclusion from QUARTET USA Trial",
      "status": "active",
      "variableDefinition": [
        {
          "description": "Screened for Participation",
          "variableRole": "population",
          "observed": {
            "reference": "#ScreenedGroup",
            "type": "Group",
            "display": "Screened for Participation"
          }
        },
        {
          "description": "Reasons for exclusion from QUARTET USA Trial",
          "variableRole": "outcome",
          "observed": {
            "reference": "EvidenceVariable/372461",
            "type": "EvidenceVariable",
            "display": "Reasons for exclusion from QUARTET USA Trial"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "count"
              }
            ]
          },
          "category": {
            "text": "Not meeting inclusion criteria"
          },
          "quantity": {
            "value": 56
          }
        },
        {
          "statisticType": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "count"
              }
            ]
          },
          "category": {
            "text": "Other reasons: \"no-shows\" for randomization"
          },
          "quantity": {
            "value": 2
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03640312-flow-milestone-0-Overall-Study-group-FG000",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"
        ]
      },
      "identifier": [
        {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312-flow-milestone-0-Overall-Study-group-FG000",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        }
      ],
      "title": "ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - STARTED at Overall Study",
      "status": "active",
      "author": [
        {
          "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
        }
      ],
      "useContext": [
        {
          "code": {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "evidence-communication",
            "display": "Evidence Communication"
          },
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "ParticipantFlowEvidence",
                "display": "ParticipantFlowEvidence"
              }
            ]
          }
        }
      ],
      "variableDefinition": [
        {
          "variableRole": "population",
          "observed": {
            "reference": "#FG000",
            "type": "Group",
            "display": "QUARTET LDQT"
          }
        },
        {
          "variableRole": "outcome",
          "observed": {
            "display": "STARTED at Overall Study"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "Count"
              }
            ]
          },
          "quantity": {
            "value": 32
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03640312-flow-milestone-0-Overall-Study-group-FG001",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"
        ]
      },
      "identifier": [
        {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312-flow-milestone-0-Overall-Study-group-FG001",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        }
      ],
      "title": "ParticipantFlowEvidence: NCT03640312 Candesartan - STARTED at Overall Study",
      "status": "active",
      "author": [
        {
          "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
        }
      ],
      "useContext": [
        {
          "code": {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "evidence-communication",
            "display": "Evidence Communication"
          },
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "ParticipantFlowEvidence",
                "display": "ParticipantFlowEvidence"
              }
            ]
          }
        }
      ],
      "variableDefinition": [
        {
          "variableRole": "population",
          "observed": {
            "reference": "#FG001",
            "type": "Group",
            "display": "Candesartan"
          }
        },
        {
          "variableRole": "outcome",
          "observed": {
            "display": "STARTED at Overall Study"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "Count"
              }
            ]
          },
          "quantity": {
            "value": 30
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03640312-flow-milestone-1-Overall-Study-group-FG000",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"
        ]
      },
      "identifier": [
        {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312-flow-milestone-1-Overall-Study-group-FG000",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        }
      ],
      "title": "ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - 6 Week Follow Up at Overall Study",
      "status": "active",
      "author": [
        {
          "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
        }
      ],
      "useContext": [
        {
          "code": {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "evidence-communication",
            "display": "Evidence Communication"
          },
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "ParticipantFlowEvidence",
                "display": "ParticipantFlowEvidence"
              }
            ]
          }
        }
      ],
      "variableDefinition": [
        {
          "variableRole": "population",
          "observed": {
            "reference": "#FG000",
            "type": "Group",
            "display": "QUARTET LDQT"
          }
        },
        {
          "variableRole": "outcome",
          "observed": {
            "display": "6 Week Follow Up at Overall Study"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "Count"
              }
            ]
          },
          "quantity": {
            "value": 32
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03640312-flow-milestone-1-Overall-Study-group-FG001",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"
        ]
      },
      "identifier": [
        {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312-flow-milestone-1-Overall-Study-group-FG001",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        }
      ],
      "title": "ParticipantFlowEvidence: NCT03640312 Candesartan - 6 Week Follow Up at Overall Study",
      "status": "active",
      "author": [
        {
          "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
        }
      ],
      "useContext": [
        {
          "code": {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "evidence-communication",
            "display": "Evidence Communication"
          },
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "ParticipantFlowEvidence",
                "display": "ParticipantFlowEvidence"
              }
            ]
          }
        }
      ],
      "variableDefinition": [
        {
          "variableRole": "population",
          "observed": {
            "reference": "#FG001",
            "type": "Group",
            "display": "Candesartan"
          }
        },
        {
          "variableRole": "outcome",
          "observed": {
            "display": "6 Week Follow Up at Overall Study"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "Count"
              }
            ]
          },
          "quantity": {
            "value": 28
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03640312-flow-milestone-2-Overall-Study-group-FG000",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"
        ]
      },
      "identifier": [
        {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312-flow-milestone-2-Overall-Study-group-FG000",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        }
      ],
      "title": "ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - COMPLETED at Overall Study",
      "status": "active",
      "author": [
        {
          "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
        }
      ],
      "useContext": [
        {
          "code": {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "evidence-communication",
            "display": "Evidence Communication"
          },
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "ParticipantFlowEvidence",
                "display": "ParticipantFlowEvidence"
              }
            ]
          }
        }
      ],
      "variableDefinition": [
        {
          "variableRole": "population",
          "observed": {
            "reference": "#FG000",
            "type": "Group",
            "display": "QUARTET LDQT"
          }
        },
        {
          "variableRole": "outcome",
          "observed": {
            "display": "COMPLETED at Overall Study"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "Count"
              }
            ]
          },
          "quantity": {
            "value": 29
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03640312-flow-milestone-2-Overall-Study-group-FG001",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"
        ]
      },
      "identifier": [
        {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312-flow-milestone-2-Overall-Study-group-FG001",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        }
      ],
      "title": "ParticipantFlowEvidence: NCT03640312 Candesartan - COMPLETED at Overall Study",
      "status": "active",
      "author": [
        {
          "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
        }
      ],
      "useContext": [
        {
          "code": {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "evidence-communication",
            "display": "Evidence Communication"
          },
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "ParticipantFlowEvidence",
                "display": "ParticipantFlowEvidence"
              }
            ]
          }
        }
      ],
      "variableDefinition": [
        {
          "variableRole": "population",
          "observed": {
            "reference": "#FG001",
            "type": "Group",
            "display": "Candesartan"
          }
        },
        {
          "variableRole": "outcome",
          "observed": {
            "display": "COMPLETED at Overall Study"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "Count"
              }
            ]
          },
          "quantity": {
            "value": 24
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03640312-flow-milestone-3-Overall-Study-group-FG000",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"
        ]
      },
      "identifier": [
        {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312-flow-milestone-3-Overall-Study-group-FG000",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        }
      ],
      "title": "ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - NOT COMPLETED at Overall Study",
      "status": "active",
      "author": [
        {
          "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
        }
      ],
      "useContext": [
        {
          "code": {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "evidence-communication",
            "display": "Evidence Communication"
          },
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "ParticipantFlowEvidence",
                "display": "ParticipantFlowEvidence"
              }
            ]
          }
        }
      ],
      "variableDefinition": [
        {
          "variableRole": "population",
          "observed": {
            "reference": "#FG000",
            "type": "Group",
            "display": "QUARTET LDQT"
          }
        },
        {
          "variableRole": "outcome",
          "observed": {
            "display": "NOT COMPLETED at Overall Study"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "Count"
              }
            ]
          },
          "quantity": {
            "value": 3
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03640312-flow-milestone-3-Overall-Study-group-FG001",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"
        ]
      },
      "identifier": [
        {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312-flow-milestone-3-Overall-Study-group-FG001",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        }
      ],
      "title": "ParticipantFlowEvidence: NCT03640312 Candesartan - NOT COMPLETED at Overall Study",
      "status": "active",
      "author": [
        {
          "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
        }
      ],
      "useContext": [
        {
          "code": {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "evidence-communication",
            "display": "Evidence Communication"
          },
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "ParticipantFlowEvidence",
                "display": "ParticipantFlowEvidence"
              }
            ]
          }
        }
      ],
      "variableDefinition": [
        {
          "variableRole": "population",
          "observed": {
            "reference": "#FG001",
            "type": "Group",
            "display": "Candesartan"
          }
        },
        {
          "variableRole": "outcome",
          "observed": {
            "display": "NOT COMPLETED at Overall Study"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "Count"
              }
            ]
          },
          "quantity": {
            "value": 6
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03640312-flow-reason-Overall-Study-group-FG000",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"
        ]
      },
      "identifier": [
        {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312-flow-reason-Overall-Study-group-FG000",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        }
      ],
      "title": "ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - Reasons for withdraw at Overall Study",
      "status": "active",
      "author": [
        {
          "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
        }
      ],
      "useContext": [
        {
          "code": {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "evidence-communication",
            "display": "Evidence Communication"
          },
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "ParticipantFlowEvidence",
                "display": "ParticipantFlowEvidence"
              }
            ]
          }
        }
      ],
      "variableDefinition": [
        {
          "variableRole": "population",
          "observed": {
            "reference": "#FG000",
            "type": "Group",
            "display": "QUARTET LDQT"
          }
        },
        {
          "variableRole": "outcome",
          "observed": {
            "display": "Reasons for withdraw at Overall Study"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "Count"
              }
            ]
          },
          "category": {
            "text": "Lost to Follow-up"
          },
          "quantity": {
            "value": 3
          }
        }
      ]
    },
    {
      "resourceType": "Evidence",
      "id": "NCT03640312-flow-reason-Overall-Study-group-FG001",
      "meta": {
        "profile": [
          "http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-evidence"
        ]
      },
      "identifier": [
        {
          "type": {
            "text": "FEvIR Linking Identifier"
          },
          "system": "https://fevir.net/FLI",
          "value": "NCT03640312-flow-reason-Overall-Study-group-FG001",
          "assigner": {
            "display": "Computable Publishing LLC"
          }
        }
      ],
      "title": "ParticipantFlowEvidence: NCT03640312 Candesartan - Reasons for withdraw at Overall Study",
      "status": "active",
      "author": [
        {
          "name": "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
        }
      ],
      "useContext": [
        {
          "code": {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "evidence-communication",
            "display": "Evidence Communication"
          },
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "https://fevir.net/resources/CodeSystem/179423",
                "code": "ParticipantFlowEvidence",
                "display": "ParticipantFlowEvidence"
              }
            ]
          }
        }
      ],
      "variableDefinition": [
        {
          "variableRole": "population",
          "observed": {
            "reference": "#FG001",
            "type": "Group",
            "display": "Candesartan"
          }
        },
        {
          "variableRole": "outcome",
          "observed": {
            "display": "Reasons for withdraw at Overall Study"
          }
        }
      ],
      "statistic": [
        {
          "statisticType": {
            "coding": [
              {
                "system": "https://fevir.net/sevco",
                "code": "STATO:0000047",
                "display": "Count"
              }
            ]
          },
          "category": {
            "text": "Lost to Follow-up"
          },
          "quantity": {
            "value": 6
          }
        }
      ]
    }
  ],
  "extension": [
    {
      "url": "http://hl7.org/fhir/StructureDefinition/artifact-description",
      "valueMarkdown": "Example for EBMonFHIR IG"
    },
    {
      "url": "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
            "code": "active",
            "display": "Active"
          }
        ]
      }
    }
  ],
  "url": "https://fevir.net/resources/Composition/370512",
  "identifier": [
    {
      "type": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code": "ACSN",
            "display": "Accession ID"
          }
        ],
        "text": "FEvIR Object Identifier"
      },
      "system": "https://fevir.net/FOI",
      "value": "370512",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    },
    {
      "type": {
        "text": "FEvIR Linking Identifier"
      },
      "system": "https://fevir.net/FLI",
      "value": "NCT03640312-participant-flow-report",
      "assigner": {
        "display": "Computable Publishing LLC"
      }
    }
  ],
  "status": "final",
  "type": {
    "coding": [
      {
        "system": "https://fevir.net/resources/CodeSystem/179423",
        "code": "ParticipantFlowReport",
        "display": "ParticipantFlowReport"
      }
    ],
    "text": "Participant Flow Report"
  },
  "date": "2025-10-21T11:07:38.408Z",
  "author": [
    {
      "display": "Joanne Dehnbostel"
    }
  ],
  "title": "Participant Flow Report for QUARTET USA Trial",
  "custodian": {
    "reference": "Organization/118079",
    "type": "Organization",
    "display": "Computable Publishing LLC"
  },
  "relatesTo": [
    {
      "type": "cite-as",
      "targetMarkdown": "Participant Flow Report for QUARTET USA Trial [Database Entry: FHIR Composition Resource]. Contributors: Joanne Dehnbostel [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370512. Revised 2025-10-21. Available at: https://fevir.net/resources/Composition/370512. Computable resource at: https://fevir.net/resources/Composition/370512#json."
    },
    {
      "type": "derived-from",
      "targetReference": {
        "reference": "Composition/370502",
        "type": "Composition",
        "display": "Participant Flow Report for NCT03640312"
      }
    }
  ],
  "section": [
    {
      "title": "Excluded",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "type": "EvidenceVariable",
        "display": "Excluded"
      },
      "entry": [
        {
          "reference": "#ExcludedCount",
          "type": "Evidence",
          "display": "Excluded from QUARTET USA Trial"
        }
      ]
    },
    {
      "title": "Reasons for exclusion",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "EvidenceVariable/372461",
        "type": "EvidenceVariable",
        "display": "Reasons for exclusion from QUARTET USA Trial"
      },
      "entry": [
        {
          "reference": "#ReasonsForExclusion",
          "type": "Evidence",
          "display": "Reasons for exclusion from QUARTET USA Trial"
        }
      ]
    },
    {
      "title": "Flow PreAssignment Details",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "participant-flow-details",
            "display": "Participant Flow Details"
          }
        ],
        "text": "FlowPreAssignmentDetails"
      },
      "text": {
        "status": "generated",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">NA - all enrolled participants were randomized.</div>"
      }
    },
    {
      "title": "Flow Recruitment Details",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "participant-flow-details",
            "display": "Participant Flow Details"
          }
        ],
        "text": "FlowRecruitmentDetails"
      },
      "text": {
        "status": "generated",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">120 were consented and assessed for eligibility. 58 were excluded for not meeting either inclusion or exclusion criteria, declining participation, or not showing up for randomization visits. Thus, these 58 individuals were not randomized, and 62 participants were randomized</div>"
      }
    },
    {
      "title": "Flow Group List",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "groups",
            "display": "Groups"
          }
        ],
        "text": "FlowGroupList"
      },
      "text": {
        "status": "generated",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\">QUARTET LDQT, Candesartan</div>"
      },
      "entry": [
        {
          "reference": "#ScreenedGroup",
          "type": "Group",
          "display": "Screened for Participation"
        },
        {
          "reference": "#FG000",
          "type": "Group",
          "display": "QUARTET LDQT"
        },
        {
          "reference": "#FG001",
          "type": "Group",
          "display": "Candesartan"
        }
      ]
    },
    {
      "title": "STARTED at Overall Study",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ],
        "text": "Participant Flow Results"
      },
      "focus": {
        "display": "STARTED at Overall Study"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-flow-milestone-0-Overall-Study-group-FG000",
          "type": "Evidence",
          "display": "ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - STARTED at Overall Study"
        },
        {
          "reference": "#NCT03640312-flow-milestone-0-Overall-Study-group-FG001",
          "type": "Evidence",
          "display": "ParticipantFlowEvidence: NCT03640312 Candesartan - STARTED at Overall Study"
        }
      ]
    },
    {
      "title": "6 Week Follow Up at Overall Study",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ],
        "text": "Participant Flow Results"
      },
      "focus": {
        "display": "6 Week Follow Up at Overall Study"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-flow-milestone-1-Overall-Study-group-FG000",
          "type": "Evidence",
          "display": "ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - 6 Week Follow Up at Overall Study"
        },
        {
          "reference": "#NCT03640312-flow-milestone-1-Overall-Study-group-FG001",
          "type": "Evidence",
          "display": "ParticipantFlowEvidence: NCT03640312 Candesartan - 6 Week Follow Up at Overall Study"
        }
      ]
    },
    {
      "title": "COMPLETED at Overall Study",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ],
        "text": "Participant Flow Results"
      },
      "focus": {
        "display": "COMPLETED at Overall Study"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-flow-milestone-2-Overall-Study-group-FG000",
          "type": "Evidence",
          "display": "ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - COMPLETED at Overall Study"
        },
        {
          "reference": "#NCT03640312-flow-milestone-2-Overall-Study-group-FG001",
          "type": "Evidence",
          "display": "ParticipantFlowEvidence: NCT03640312 Candesartan - COMPLETED at Overall Study"
        }
      ]
    },
    {
      "title": "NOT COMPLETED at Overall Study",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ],
        "text": "Participant Flow Results"
      },
      "focus": {
        "display": "NOT COMPLETED at Overall Study"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-flow-milestone-3-Overall-Study-group-FG000",
          "type": "Evidence",
          "display": "ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - NOT COMPLETED at Overall Study"
        },
        {
          "reference": "#NCT03640312-flow-milestone-3-Overall-Study-group-FG001",
          "type": "Evidence",
          "display": "ParticipantFlowEvidence: NCT03640312 Candesartan - NOT COMPLETED at Overall Study"
        }
      ]
    },
    {
      "title": "Reasons for withdraw at Overall Study",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ],
        "text": "Participant Flow Results"
      },
      "focus": {
        "display": "Reasons for withdraw at Overall Study"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-flow-reason-Overall-Study-group-FG000",
          "type": "Evidence",
          "display": "ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - Reasons for withdraw at Overall Study"
        },
        {
          "reference": "#NCT03640312-flow-reason-Overall-Study-group-FG001",
          "type": "Evidence",
          "display": "ParticipantFlowEvidence: NCT03640312 Candesartan - Reasons for withdraw at Overall Study"
        }
      ]
    }
  ]
}