Instructions for Completing SAE

• Please review the attached SAE Form (3 pages)

• Using the attached narrative template complete the SAE narrative
• Please remember to focus on 3 things in writing this narrative:
- Follow the template
- Complete the narrative in chronological order
- Complete the narrative in a concise manner
• We ask that you take just 30 minutes to complete
• Style is not important
Lifecycle Safety-Serious Adverse Event (SAE) Form Page 1 of 4

Study: Subject ID
Pharma1
5 6 2 3 1 2 3 4 5

Date of report: 2 5 J A N 2 0 2 1 Type of Report:  Initial  Follow-up

Day Month Year

Date of awareness: 2 6 J A N 2 0 2 1
Day Month Year

Sex:  Male  Female Date of birth: J U L 1 9 6 6

Month Year

Serious Adverse Event Term(s): Cardiogenic Shock

Onset Date: 0 9 J A N 2 0 2 1 Resolution Date: 1 2 J A N 2 0 2 1

Day Month Year Day Month Year

Serious Criteria (check all that apply):

 Death  Life-threatening  Initial or prolonged hospitalization*  Congenital anomaly/birth defect
 Persistent or significant disability/incapacity  Medically significant event

*Hospitalization*: Admission Discharge

Date
0 9 J A N 2 0 2 1 Date
1 3 J A N 2 0 2 1
Day Month Year Day Month Year

Severity:  Mild  Moderate  Severe

Relationship to Study Drug/Placebo (check one): In your medical judgment, is there a reasonable
possibility that the adverse event may have been caused by the trial therapy? (check one):

 Related  Not Related

Please provide investigator rationale:
_____________________________________________________________________________________________

Outcome/Consequences of adverse event (check one):

 Recovered / Resolved  Recovered / Resolved with sequelae  Not recovered/Not resolved
 Recovering / Resolving  Fatal
Lifecycle Safety-Serious Adverse Event (SAE) Form Page 2 of 4

SERIOUS ADVERSE EVENT REPORT

Study: Subject ID
Pharma1
5 6 2 3 1 2 3 4 5

Death Information Primary Cause of Death: ________________________________

Date of Death:
Was a death certificate obtained?  Yes  No  Pending
Was an autopsy performed?  Yes  No  Pending
Day Month Year

Study Drug Information: XWZ-01

Dose: 200mg Frequency: qid Route: Oral Lot/Batch #:25331

Date of FIRST dose: Date of LAST dose prior to the event:

2 0 D E C 2 0 2 0 0 8 J A N 2 0 2 1
Day Month Year Day Month Year

Action taken regarding Study Drug /Placebo (check one):

 Dose not changed  Drug withdrawn*  Drug Interrupted**  Not applicable

*Date drug withdrawn:

*
Day Month Year

**Date drug interrupted:

Day Month Year

Did event abate after study drug discontinuation or delay?  Yes  No Not applicable

Did event reappear after study drug restarted?  Yes  No  Not applicable

Treatment: Describe any medical interventions, medications, and/or surgical treatments used to treat the event.

norepinephrine 400mg IV bid from 09-Jan-2021 to 12-Jan-2021.

 Lifecycle Safety-Serious Adverse Event (SAE) Form Page 3 of 4

SERIOUS ADVERSE EVENT REPORT

Study:
Pharma1 Subject ID
5 6 2 3 1 2 3 4 5

Relevant Concomitant Medications: Identify concomitant medications (list medications taken at the time of the event and
14 days prior to the event). Do not include medications used to treat the adverse event.
Dosing Start Date Stop Date
Medication Indication Ongoing
Regimen DD/MMM/YYYY DD/MMM/YYYY
NORVASC hypertension 50 mg, qd 2000

(amlodipine)
Cymbalta (duloxetine) depression 30 mg, qd 2010 



Relevant Medical History:

Start Date Stop Date
Condition Ongoing
day/month/year day/month /year
hypertension 2000 


Event Description/Case Narrative: Description of the clinical presentation/course of the event(s), dates, times, treatment,
and any other assessments which help explain the event.

The patient was admitted on 09-Jan-2021 due to Cardiogenic shock. On 10-Jan-2021 an ECG
showed sinus arrhythmia and a blood culture was negative. See additional Information from 11-
Jan-2021 below.
Reporter’s Name: John Smith Phone Number: ______XXXXXXXX__ Fax Number: _______________

Investigator’s Name: John Smith

Investigator’s Signature: John Smith Date Signed: 26-Jan-2021

Please return your completed form to IQVIA Safety: Safety_Pharma1@[Link]

Labs on 11-Jan-2021

Labs value Reference range

Sodium 139 132-144 meq/L
ALT 69 17-63 IU/L
Lifecycle Safety-Serious Adverse Event (SAE) Form Page 4 of 4

Narrative Template:

Subject#:

This [SUBJECT_AGE] [SUBJECT_AGE_UNIT] old [SUBJECT_SEX] subject was

participating in [STUDY DESCRIPTION] and developed [ENTER DESCRIPTION
AS REPORTED TERM].

The subject’s medical history provided by the investigator included [HISTORICAL

AND CURRENT CONDITION / OTHER RELEVANT HISTORY]. Concomitant
medications reported included [CONCOMITANT MEDICATION GENERIC
NAMES].

The subject received the first dose investigational study drug on [DOSAGE
REGIMEN START DATE], Lot number [#].

On [EVENT ONSET DATE OF THE PRIMARY EVENT], the subject developed /

experienced [ENTER PRIMARY DESCRIPTION AS REPORTED TERM] which
met the serious criteria of (add serious criteria).{Insert relevant /abnormal labs
and/or diagnostic data in format [LAB RESULT UNIT (LOW-HIGH UNIT)] and
any additional clinical info reported on SAE form}. Treatment for the event
included [TREATMENT DRUG GENERIC NAME(s), ROUTE DRUG DOSE
UNIT; FREQUENCY, DATES, if available] OR {No treatment information was
reported by the investigator}.

The subject’s last dose of investigational drug prior to the event was on
[DOSAGE REGIMEN STOP DATE].

The action taken with the study drug was reported as (add action taken).

The event [ENTER DESCRIPTION AS REPORTED TERM(S)] was reported as

[EVENT OUTCOME] ON [STOP DATE]. (The subject died on {enter date of
death}. The cause of death was reported as {cause of death} OR {unknown}).
Add additional details, if applicable.

The investigator reported that [DESCRIPTION AS REPORTED TERM(s)] was

<not / unlikely/ possibly /probably/ definitely> related to <investigational drug>.