The objective of this paper is to outline the serious adverse event narrative, providing a sample

1. Describe serious adverse event narrative writing. Write a sample serious adverse event narrative
1
Describe serious adverse event narrative writing.
Write a sample serious adverse event narrative
Fernanda Ferreira, f.lima22
Student of Advanced Post Graduate Diploma in Pharmacovigilance & Medical Writing,
James Lind Institute, Jul-2016
The objective of this paper is to outline the serious adverse event narrative, providing a sample
Serious adverse event narratives:
background and definitions
Before defining case narrative, it is important
to explain the concept of Individual Case
Safety Report (ICSR); this well known
pharmacovigilance report captures information
about adverse events and product problems
that are reported to public health, patient
safety/quality improvement organizations or
regulatory agencies. The ICSR message
supports reporting from a variety of sources
such as consumers, hospitals, contract research
organizations, clinicians or pharmaceutical
product and medical device manufacturers1
.
Within the structure of an ICSR, the narrative
is a text that summarizes all relevant clinical
and related information, including patient
characteristics, therapy details, medical
history, clinical course of the event (s),
diagnosis and ADR(s) including the outcome,
laboratory evidence (including normal ranges),
and any other information that supports or
refutes and ADR. Narratives should serve as a
comprehensive, stand-alone "medical history".
The information should be presented in a
logical time sequence; ideally this should be
presented in the chronology of the patient's
experience, rather than in the chronology in
which the information was received. In follow-
up reports, new information should be clearly
identified2
.
In the context of clinical trials, narratives are
present under the structure of Clinical Study
Reports (CSR), that, according to the
International Conference on Harmonisation
(ICH) tripartite guideline on the Structure and
Content of CSRs E3 (Section 12.3.2), a CSR
should contain brief narratives describing each
death, each other serious adverse event, and
other significant adverse events that are judged
to be of special interest because of clinical
importance3
.
Pharmacovigilance in clinical trials is the
monitoring of the Serious Adverse Events
(SAEs) that occur to the participating patients
in a trial. Patient safety in clinical trials needs
continuous monitoring. All adverse events are
documented whether they are considered
related or not to the study drug (although only
the SAEs / SAEs narratives should be
transmitted to regulators). Safety information
from clinical studies is used to establish a
drug’s safety profile in humans and is a key
component that drug regulatory authorities
consider in the decision-making as to whether
to grant or deny market authorization (market
approval) for a drug4
.
Considering the narratives written for the post-
marketing experiences, they have a different
nature than those written for subjects in
controlled studies, because the only
information the Sponsor has about the patient
has come from the reporting physician and
thus they are entirely written from the safety
reports obtained from the Safety Officer. Any
numbers on serious adverse events calculated
post-marketing are undercounted, reasons for
undercounting include patients not telling
healthcare professionals which drugs they are
taking and also, patients not reporting serious
adverse events to healthcare professionals.
With chemotherapy drugs, this is less likely to
be so5
.
Other considerations for narratives include that
abbreviations and acronyms should be

2. Describe serious adverse event narrative writing. Write a sample serious adverse event narrative
2
avoided, with the possible exception of
laboratory parameters and units. Key
information from supplementary records
should be included in the report, and their
availability should be mentioned in the
narrative and supplied on request. Any
relevant autopsy or post-mortem findings
should also be summarized in the narrative and
related documents should be provided
according to local regulation and if allowed by
local data privacy laws2
.
SAE narrative example
Subject xxxxxx had cancer (disease needs to
be specified), which was diagnosed in Jun
1998. The subject previously received
treatment with vincristine, dexamethasone,
melphalan, and prednisone. The subject’s
pertinent medical history included cardiac
arrhythmia, myocardial infarction, deep vein
thrombosis, hypercholesterolemia, acute renal
failure, and hypertension. On 30 Apr 2001
(Cycle 1, Day 33; 15 days after completing
Cycle 1 therapy), the subject was admitted to
the hospital for treatment of acute renal
insufficiency. The subject complained of a
cough one week before admission, and was
treated with a dose of pentamidine for
Pneumocystis carinii pneumonia and reported
decreased urine output since that time. A
baseline 24-hour urine collection on 14 Mar
2001 revealed 75% lambda light chain Bence-
Jones protein, a total protein of 2700 mg/24
hours, and a urine M-protein of 2025 mg/24
hours; the investigator considered that the
increase in monoclonal proteins was related to
a dental abscess. On 27 Mar 2001, his baseline
creatinine was 1.9 mg/dL. On admission, the
subject’s creatinine was 4.9 mg/dL, BUN was
72 mg/dL, and potassium was 5.5 mEq/L. His
cloudy yellow urine had 30 mg/dL protein and
bacteria (cultured as coagulase-negative
Staphylococcus). An abdominal ultrasound
showed a slight increase in echogenicity and
irregular renal cortices that were consistent
with renal disease. A physical examination
revealed right lung base crackles and a
temperature of 38.1C. On the following day,
01 May 2001, the subject’s creatinine was 4.9
mg/dL, BUN was 62 mg/dL, and potassium
was 4.7 mEq/L. The subject was discharged on
4 May 2001 (Day 38) with a creatinine of 4.6
mg/dL and a BUN of 65 mg/dL, and the event
was considered resolved with sequelae. The
subject was given levofloxacin at discharge. A
24-hour urine collection on 24 May 2001
revealed 5.24 g/24 hours Bence-Jones protein,
total protein of 5 mg/24 hours, urine M-protein
of 4 mg/24 hours, and a creatinine of 4.8 g/24
hours. The subject was discontinued from the
study because of progressive multiple
myeloma on 29 May 2001. Concomitant
medications included albuterol, atenolol,
atorvastatin, dalteparin, enalapril, enoxaparin,
erythromycin, loratadine, omeprazole,
pamidronate, pentamidine, and simvastatin.
In the opinion of the investigator, the Grade 3
acute renal insufficiency was unrelated to
dexamethasone5
.
References
1. HL7 Version 3 Standard:
Pharmacovigilance - Individual Case Safety
Report, Part 2: Human Pharmaceutical
Reporting Requirements for ICSR, R2. Health
Level Seven website.
http://www.hl7.org/implement/standards/produ
ct_brief.cfm?product_id=267. Accessed on
08/03/16.
2. ICH E2D – Post Approval Safety Data
Management. EMEA website.
eudravigilance.ema.europa.eu/human/docs/IC
H%20E2D.pdf. Accessed on 08/03/16.
3. Patient Safety Narratives - Clinical Trials:
Medical Writing & Patient Safety Narratives.
Drug Development & Delivery website.
http://www.drug-dev.com/Main/Back-
Issues/PATIENT-SAFETY-NARRATIVES-
Clinical-Trials-Medical-921.aspx. Accessed on
08/03/16.
4. Clinical Pharmacovigilance. PV Net.
http://pvnet.sarjen.com/pharmacovigilance/clin
ical-pharmacovigilance/. Accessed on
08/03/16.
5. Dodgson S. Writing narrative reports.
MJota website.
http://www.mjota.org/images/Narrative_Prepa
ration_11-14-2003_sjd.doc. Accessed on
07/22/16.