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Purpose
Record a brief description of major medical, surgical events and Past Cardiac History/ Cardiac Disease Details during the patient's lifetime, excluding the events related to their cancer therapy.
Screening Physical Exam findings should be entered on the Screening Physical Exam eCRF.
Baseline Medical History eCRF:
Field Descriptions and Instructions
Field Name | Description / Instructions | Format |
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Visit Date (m) | Enter the date the form was completed (i.e. the date information was gathered). | DD-MMM-YYYY |
Date of Examination (m) | Enter the date that the patient was examined and the medical history was documented. Since only one Baseline Medical History | DD-MMM-YYYY |
Body System | Predefined Body System. It cannot be changed. | text |
Finding Results (m) | Indicate whether the finding results for the particular body system were either: Note: Do not select ‘Normal” if the body system was not specifically assessed (i.e.: not mentioned in the progress note in the medical record). | 1 digit |
Medical History if Abnormal | Enter a brief description of major medical and surgical events during the patient's lifetime (i.e.: hypertension under cardiovascular, appendectomy as child under abdomen). Example: Breast cancer (age 55); Type II Diabetes (1999) For "Other" indicate the body or organ system in the history. | 128 characters |
Legend: (d) derived field, (m) RDC mandatory.
Validations
Code | Description | Resolutions |
---|---|---|
MH01 | Date of Examination is in the future. | Enter a date that is earlier or equals to the current date. |
MH02 | Date of Examination is after the first Course Initiation Start Date. | Review the Date of Examination and/or the first Course Initiation Start Date. |
MH03 | ‘Finding Result’s is marked abnormal and ‘Medical History if Abnormal’ details were not provided. | Enter the details of the ‘Medical History if Abnormal’ or change the ‘Finding Results’ selection. |
MH04 | ‘Medical History if Abnormal’ details were specified and ‘Finding Results’ is not marked abnormal. | Change the ‘Finding Results’ to abnormal or remove the provided ‘Medical History if Abnormal’ details. |
Baseline Medical History eCRF- Past Cardiac History/ Cardiac Disease Details:
Field Descriptions and Instructions
Field Name | Description / Instructions | Format |
---|---|---|
Congestive Heart Failure | Select the response related to the participant's medical history of congestive heart failure.
| Use pick list. |
Congestive Heart Failure (Meets NYHA Class III&IV Definitions) | Indicate whether the patient has ischemic heart disease Class III or IV based on the New York Heart Association.
| Use pick list. |
One Year MI History Prior to Registration | Indicate whether a patient has a history of myocardial infarction (MI) one year prior to clinical trial registration.
| Use pick list. |
Most Recent MI Date | Enter calendar data of the most recently occurring myocardial infarction (MI) in a patient. | DD-MMM-YYYY |
Dysrhythmias | Indicate whether a patient experienced any cardiac dysrhythmia(s).
| Use pick list. |
Dysrhythmias (controlled/ uncontrolled?) | Indicate whether a cardiac dysthymia is being managed and under control.
| Use pick list. |
Angina | Select the response related to previous or current symptoms described as chest pain or pressure, jaw pain, arm pain, or other equivalent discomfort suggestive of cardiac ischemia.
| Use pick list. |
Stable Angina | Indicate whether stable angina, recurring thoracic pain or discomfort which occurs when a part of the heart does not receive enough blood showing little if any change,
| Use pick list. |
Left ventricular hypertrophy | Indicate whether absent or present indicator of enlargement or overgrowth of the myocardium of the left ventricle, due to chronic pressure overload:
| Use pick list. |
Other Cardiac Condition | Indicate whether a patient has experienced any cardiac disease history that is different from conditions already identified:
| Use pick list. |
Other, specify | Enter text description of a cardiac condition that is different from those already identified. | 100 characters |
Legend: (d) derived field, (m) RDC mandatory .
Validations
Code | Description | Resolutions |
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TBD |
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