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    Medical Writing Sample

    Uploaded by

    Justeena Kaithaparambil
    1) A 66-year-old male patient with type 2 diabetes and other comorbidities experienced an episode of supraventricular tachycardia while participating in a clinical trial of Drug P. 2) During a routine follow-up, the patient was found to have a rapid heart rate of 150 beats per minute and was admitted to the hospital. 3) Tests including ECG, cardiac biomarkers and overnight monitoring found no underlying cause and the patient recovered without any changes made to his trial medication.

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    Medical Writing Sample

    Uploaded by

    Justeena Kaithaparambil
    315 views2 pages
    1) A 66-year-old male patient with type 2 diabetes and other comorbidities experienced an episode of supraventricular tachycardia while participating in a clinical trial of Drug P. 2) During a routine follow-up, the patient was found to have a rapid heart rate of 150 beats per minute and was admitted to the hospital. 3) Tests including ECG, cardiac biomarkers and overnight monitoring found no underlying cause and the patient recovered without any changes made to his trial medication.

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    1) A 66-year-old male patient with type 2 diabetes and other comorbidities experienced an episode of supraventricular tachycardia while participating in a clinical trial of Drug P. 2) During a routine follow-up, the patient was found to have a rapid heart rate of 150 beats per minute and was admitted to the hospital. 3) Tests including ECG, cardiac biomarkers and overnight monitoring found no underlying cause and the patient recovered without any changes made to his trial medication.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    315 views2 pages

    Medical Writing Sample

    Uploaded by

    Justeena Kaithaparambil
    1) A 66-year-old male patient with type 2 diabetes and other comorbidities experienced an episode of supraventricular tachycardia while participating in a clinical trial of Drug P. 2) During a routine follow-up, the patient was found to have a rapid heart rate of 150 beats per minute and was admitted to the hospital. 3) Tests including ECG, cardiac biomarkers and overnight monitoring found no underlying cause and the patient recovered without any changes made to his trial medication.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Sample – Safety Narrative Writing

    Seriousness criterion of the event


    Death:
    Serious adverse event:
    Involved or Prolonged inpatient Hospitalisation
    Discontinuation due to laboratory abnormality:
    Life Threatening

    Protocol: Gxxxxxx
    Subject identifier: Y
    Subject demographics: 66-year-old of unknown male
    Treatment group: Drug P: z mg x y days
    Date of first dose of study drug: DD-MM - YYYY
    Date of last dose of study drug: DD-MM - YYYY
    Serious adverse event (Preferred Term): Superventricular Tachycardia

    Narrative: This is the report from the clinical study entitled “A Long-term, Multi-centre, International, Randomised
    Double-blind, Placebo-controlled Trial to Determine Drug P Effects on Cardiovascular Events” carried out by healthcare
    professionals (HCP). Subject Mr.D had type 2 diabetes mellitus which was diagnosed in 1996. The subject had co morbid
    conditions like hyperlipidaemia, hypertension, bowel obstruction and also partial pancreatectomy and splenectomy was
    done. During the study the subject haven’t received any relevant concomitant medication associated with the event. The
    patient had a no history of tobacco use.

    On DD-MM - YYYY the patient was treated with trial drug P Vs. Placebo and on-going for type 2 diabetes mellitus. On
    DD-MM - YYYY, during the routine follow up with a doctor the medical assistant visualized a rapid, fast heart rate and
    reported to the doctor. The doctor examined the subject heart rate to be at 150 beats/min and the blood pressure (B/P) was
    118/80.An electrocardiogram (ECG) examination revealed cardiac arrhythmia, possible sinus tachycardia, left axis
    deviation, right bundle branch block (RBBB) with left anterior fascicular block, inferior infarct-age undetermined, lateral T
    wave changes may be an indicative of myocardial ischemia. Meanwhile, on DD-MM - YYYY Electrocardiogram (EKG)
    examination showed cardiac arrhythmia. The subject was asymptomatic and administered with Aspirin (acetylsalicylic
    acid) and water, then admitted to the hospital. Further to confirm, the cardiac biomarkers analysis was performed on DD-
    MM - YYYY and results were as follows, Blood creatine phosphokinase (CPK) was 109.0 U/L, CPKMB was 1.2 ng/mL,
    CPK-MB repeat was <0.01 ng/mL, Troponin I was <0.05 ng/mL and finally Troponin I repeat was <0.02 ng/mL. The
    subject was monitored overnight, but no cause of cardiac arrhythmia was found. On DD-MM - YYYY the patient had
    recovered and was discharged. Based on the medical records, the investigator indicated as supraventricular tachycardia.
    The cardiac biomarkers were found to be in the normal clinical range. The event was not associated with acute coronary
    syndrome but with trifascicular block and aortic valve sclerosis. The action taken to trial drug was reported as dose not
    changed. Dechallenge and Re-challenge was missing. Finally, on DD-MM - YYYY trial drug was un-blinded according
    to regulatory requirements.

    In the opinion of the sponsor, array of clinical scenarios can lead to or cause arrhythmia (supraventricular tachycardia)
    including high blood pressure, diabetes, stress, alcohol and coronary artery disease. The patient had been treated with trial
    drug for almost two years before the event which does not indicate a chronological relationship. Furthermore the patient
    recovered without changes made to trial drug administration. With the provided information the sponsor assesses the event
    and trial drug as unlikely related.

    In the opinion of the investigator, the event assessed as possibly related.

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