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Adverse Event

Adverse event data are mapped to FHIR's Adverse Event resource. This is not a visit specific data element and does not require any adjudication by study staff.

NOTE: The data set available does not currently include lab toxicities.

Request

GET /msk-apim/external/v2/crit/blaze/api/AdverseEvent
-H Authorization: Bearer {access_token} 
-H x-partnerid: {partnerId}

Query Parameters

Parameters Type Is Required Description
researchstudy string true MSK unique study number
x-partnerid string true MSK provided partner ID

For a list of optional filtering parameters visit the Searching page.

Example Code

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var client = new RestClient("BASE_URL_PLUS_API_PATH?researchstudy={A1}");
client.Timeout = -1;
var request = new RestRequest(Method.GET);
request.AddHeader("Authorization", "Bearer {ACCESS_TOKEN}");
request.AddHeader("x-partnerid", "{partnerId}");
IRestResponse response = client.Execute(request);
Console.WriteLine(response.Content);

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import http.client

conn = http.client.HTTPSConnection("BASE_URL")
payload = ''
headers = {
'Authorization': 'Bearer {ACCESS_TOKEN}',
'x-partnerid': '{partnerId}'
}
conn.request("GET", "API_PATH?researchstudy={A1}", payload, headers)
res = conn.getresponse()
data = res.read()
print(data.decode("utf-8"))

Response

Successful Payload Example 
{
"resourceType": "Bundle",
"identifier": {
    "system": "https://fhir.mskcc.org/structure-definitions/#IDB.Protocol",
    "value": "FHIR-T"
},
"type": "searchset",
"total": 1041,
"link": [
    {
      "relation": "self",
      "url": "https://apigateway.apps.stageapi.mskcc.org/msk-apim/external/v2/crit/blaze/api/adverseevent?researchstudy=FHIR-T&_count=3&page=1"
    },
    {
      "relation": "first",
      "url": "https://apigateway.apps.stageapi.mskcc.org/msk-apim/external/v2/crit/blaze/api/adverseevent?researchstudy=FHIR-T&_count=3&page=1"
    },
    {
      "relation": "last",
      "url": "https://apigateway.apps.stageapi.mskcc.org/msk-apim/external/v2/crit/blaze/api/adverseevent?researchstudy=FHIR-T&_count=3&page=347"
    },
    {
      "relation": "next",
      "url": "https://apigateway.apps.stageapi.mskcc.org/msk-apim/external/v2/crit/blaze/api/adverseevent?researchstudy=FHIR-T&_count=3&page=2"
    }
],
"entry": [
    {
        "fullUrl": "https://apigateway.apps.stageapi.mskcc.org/msk-apim/external/v2/crit/blaze/api/adverseevent?researchstudy=FHIR-T&page=1&_count=3&_Id=10081004",
        "resource": {
        "resourceType": "AdverseEvent",
        "id": "10081004",
        "extension": [
            {
            "url": "https://fhir.mskcc.org/structure-definitions/#SponsorID",
            "valueString": "C3861001"
            },
            {
            "url": "https://fhir.mskcc.org/structure-definitions/#StartDate",
            "valueString": "07/05/2021"
            },
            {
            "url": "https://fhir.mskcc.org/structure-definitions/#AdverseEventSequenceNumber",
            "valueInteger": 1
            },
            {
            "url": "https://fhir.mskcc.org/structure-definitions/#VerifiedIndicator",
            "valueInteger": 0
            },
            {
            "url": "https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm#Grade",
            "valueInteger": 1
            },
            {
            "url": "https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm",
            "valueDecimal": 5.0
            },
            {
            "url": "https://fhir.mskcc.org/structure-definitions/#AEOngoing",
            "valueInteger": 0
            }
        ],
        "identifier": {
            "system": "https://fhir.mskcc.org/structure-definitions/",
            "value": "FHIR-T-FHIR-00002-41-1"
        },
        "actuality": "actual",
        "event": {
            "coding": [
            {
                "system": "https://www.meddra.org",
                "display": "Abdominal pain"
            }
            ]
        },
        "subject": {
            "reference": "Patient/10081004",
            "display": "10081004"
        },
        "date": "2021-07-05T00:00:00",
        "outcome": {
            "coding": [
            {
                "system": "http://hl7.org/fhir/2021Mar/valueset-adverse-event-outcome.html",
                "code": "ongoing",
                "display": "Ongoing"
            }
            ]
        },
        "suspectEntity": [
            {
            "causality": [
                {
                "assessment": {
                    "coding": [
                    {
                        "system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
                        "display": "Possible"
                    }
                    ]
                },
                "productRelatedness": "PF-06801591"
                }
            ]
            }
        ],
        "study": [
            {
            "reference": "Study/FHIR-T"
            }
        ]
        }
    },
    {
        "fullUrl": "https://apigateway.apps.stageapi.mskcc.org/msk-apim/external/v2/crit/blaze/api/adverseevent?researchstudy=fhir-t&page=1&_count=3&_Id=10081004",
        "resource": {
        "resourceType": "AdverseEvent",
        "id": "10081004",
        "extension": [
          {
            "url": "https://fhir.mskcc.org/structure-definitions/#SponsorID",
            "valueString": "C3861001"
          },
          {
            "url": "https://fhir.mskcc.org/structure-definitions/#StartDate",
            "valueString": "07/05/2021"
          },
          {
            "url": "https://fhir.mskcc.org/structure-definitions/#AdverseEventSequenceNumber",
            "valueInteger": 1
          },
          {
            "url": "https://fhir.mskcc.org/structure-definitions/#VerifiedIndicator",
            "valueInteger": 0
          },
          {
            "url": "https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm#Grade",
            "valueInteger": 1
          },
          {
            "url": "https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm",
            "valueDecimal": 5.0
          },
          {
            "url": "https://fhir.mskcc.org/structure-definitions/#AEOngoing",
            "valueInteger": 0
          }
        ],
        "identifier": {
          "system": "https://fhir.mskcc.org/structure-definitions/",
          "value": "FHIR-T-FHIR-00002-41-1"
        },
        "actuality": "actual",
        "event": {
          "coding": [
            {
              "system": "https://www.meddra.org",
              "display": "Abdominal pain"
            }
          ]
        },
        "subject": {
          "reference": "Patient/10081004",
          "display": "10081004"
        },
        "date": "2021-07-05T00:00:00",
        "outcome": {
          "coding": [
            {
              "system": "http://hl7.org/fhir/2021Mar/valueset-adverse-event-outcome.html",
              "code": "ongoing",
              "display": "Ongoing"
            }
          ]
        },
        "suspectEntity": [
          {
            "causality": [
              {
                "assessment": {
                  "coding": [
                    {
                      "system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
                      "display": "Possible"
                    }
                  ]
                },
                "productRelatedness": "PF-06801591"
              }
            ]
          }
        ],
        "study": [
          {
            "reference": "Study/FHIR-T"
          }
        ]
      }
    },
    {
        "fullUrl": "https://apigateway.apps.stageapi.mskcc.org/msk-apim/external/v2/crit/blaze/api/adverseevent?researchstudy=fhir-t&page=1&_count=3&_Id=10081004",
        "resource": {
        "resourceType": "AdverseEvent",
        "id": "10081004",
        "extension": [
          {
            "url": "https://fhir.mskcc.org/structure-definitions/#SponsorID",
            "valueString": "C3861001"
          },
          {
            "url": "https://fhir.mskcc.org/structure-definitions/#StartDate",
            "valueString": "07/05/2021"
          },
          {
            "url": "https://fhir.mskcc.org/structure-definitions/#AdverseEventSequenceNumber",
            "valueInteger": 1
          },
          {
            "url": "https://fhir.mskcc.org/structure-definitions/#VerifiedIndicator",
            "valueInteger": 0
          },
          {
            "url": "https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm#Grade",
            "valueInteger": 1
          },
          {
            "url": "https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm",
            "valueDecimal": 5.0
          },
          {
            "url": "https://fhir.mskcc.org/structure-definitions/#AEOngoing",
            "valueInteger": 0
          }
        ],
        "identifier": {
          "system": "https://fhir.mskcc.org/structure-definitions/",
          "value": "FHIR-T-FHIR-00002-41-1"
        },
        "actuality": "actual",
        "event": {
          "coding": [
            {
              "system": "https://www.meddra.org",
              "display": "Abdominal pain"
            }
          ]
        },
        "subject": {
          "reference": "Patient/10081004",
          "display": "10081004"
        },
        "date": "2021-07-05T00:00:00",
        "outcome": {
          "coding": [
            {
              "system": "http://hl7.org/fhir/2021Mar/valueset-adverse-event-outcome.html",
              "code": "ongoing",
              "display": "Ongoing"
            }
          ]
        },
        "suspectEntity": [
          {
            "causality": [
              {
                "assessment": {
                  "coding": [
                    {
                      "system": "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess",
                      "display": "Possible"
                    }
                  ]
                },
                "productRelatedness": "PF-06801591"
              }
            ]
          }
        ],
        "study": [
          {
            "reference": "Study/FHIR-T"
          }
        ]
      }
    }
  ]
}

Field Definitions

Field Description
id
extension[0].url MSK identifiers documentation
extension[0].valueCode Sponsor Study Number
extension[1].url MSK identifiers documentation
extension[1].valueCode Start date as it appears in the source system
extension[2].url MSK identifiers documentation
extension[2].valueCode End date as it appears in the source system
extension[3].url MSK identifiers documentation
extension[3].valueCode System generated sequential sub number of an adverse event
extension[4].url MSK identifiers documentation
extension[4].valueCode Whether or not an event was verified in the source system
extension[5].url Common Terminology Criteria for Adverse Events (CTCAE)
extension[5].valueCode Grade of the Adverse Event
extension[6].url Common Terminology Criteria for Adverse Events (CTCAE)
extension[6].valueCode Adverse Event Version
extension[7].url MSK identifiers documentation
extension[7].valueCode Whether or not an event is Ongoing
identifier.system MSK Structural Definitions documentation
identifier.value Protocol Number - MRN - Adverse Event No - Sequence No
actuality hardcoded to Actual
event.coding.system MedDRA documentation
event.coding.display Adverse Event Toxicity
subject.reference Patient/ + Sponsor assigned subject ID
subject.display Sponsor assigned subject ID
date Adverse Event Start Date
outcome.coding.system FHIR Adverse Event Outcome documentation
outcome.coding.code
outcome.coding.display
suspectEntity.causality.assessment.coding.system FHIR Adverse Event Causality documentation
suspectEntity.causality.assessment.coding.display
suspectEntity.causality.productRelatedness Investigational agent
study.reference Study/ + MSK unique study number
study.identifier.value
study.display hardcoded to AdverseEvent