Contents

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

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
form is used, if the information has been assembled over a period of time, enter the date of the latest examination.

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:
N - Normal
A - Abnormal
Z - Not Assessed
L - Not Applicable
Comments are required for abnormal finding results.

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).
‘Not Assessed’ means a discussion on the body system was not raised or the body system was not assessed.

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).
Enter the history for the appropriate body system to which the information refers. Include the year of diagnosis or patient age at onset in parentheses if needed.

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.

  • NO

  • YES

  • UNKNOWN

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.

  • NO

  • YES

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.

  • NO

  • YES

  • UNKNOWN

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).

  • NO

  • YES

  • UNKNOWN

Use pick list.

Dysrhythmias (controlled/ uncontrolled?)

Indicate whether a cardiac dysthymia is being managed and under control.

  • CONTROLLED

  • UNCONTROLLED

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.

  • NO

  • YES

  • UNKNOWN

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,
as a definite pathologic process with a characteristic set of signs and symptoms is present.

  • NO

  • YES

  • UNKNOWN

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:

  • ABSENT

  • PRESENT

  • UNKNOWN

Use pick list.

Other Cardiac Condition

Indicate whether a patient has experienced any cardiac disease history that is different from conditions already identified:

  • NO

  • YES

  • UNKNOWN

Use pick list.

Other, specifyEnter 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

TBD