You are on page 1of 24

Case Record

20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Initial Receipt Date: 08-AUG-2017
Initial Case User: *Kelly McIntosh
Initial Case Site: Cincinnati
General Information
Report Type Country Initial Receipt Date Aware Date: Medically Confirm Case Status
Sponsored Trial UNITED STATES 08-AUG-2017 12-JUL-2018 Closed

DO NOT USE DO NOT USE Classification

Case Close Date CRA Reconciliation Date Phase at Time of Event


24-OCT-2017 00:00 treatment
Follow-up Log
# Follow-up Received DO NOT USE Significant Follow-up Amendment Amendment /
4 12-JUL-2018 Yes No Yes No
3 12-OCT-2017 Yes No Yes No
2 11-SEP-2017 Yes No Yes No
1 25-AUG-2017 Yes No Yes No
Study Information
Project ID Study ID Site Number
SYNT103 SYNT001-103 205
Study Type Blinding Status Unblinding Date Drugs
Not Blinded Not Blinded 1
Observe Study Type Reason for Unblinding
Clinical Trials
Study Name Study Phase Study Description
SYNT001 A Phase 1b, Multicenter, Open-Label, Safety, Tolerability, and Activity Study of SYNT001 in Subjects with Chronic Pemphigus
(Vulgaris or Foliaceus)
Reporter Information
1 Name Occupation Health Care Professional
Dr. Donna Culton Physician Yes
Institution Institution ID Department
University of North Carolina (UNC)
Address 1 Address 2
410 Market StreetSuite 400

Katie Ahern Page 1 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
City State County Postal Code
Chapel Hill NC 27516
Country Phone Number
UNITED STATES 919-966-8797

Reporter Type
Physician
Report Sent to Regulatory Authority by Reporter? Primary Reporter
Yes No Unk Protect Confidentiality
Reporter Notes

Patient Information
Pat. ID Title Initials
205-001

Child Only Case


Address 2

County

Email Address

Date of Birth Age Units Age Group Height Weight


09-JAN-1998 19 Year Adult 67.323 in 158.760 lbs Concomitant Therapy Administered
171.000 cm 72.000 kgs

Gender Pregnant Date of LMP


Male Breastfeeding
Age at Vaccination Units (at Vaccination) Ethnic Group Military Status
Not Hispanic or Latino
Race Information
African American
Ethnicity
Not Hispanic or Latino
Pregnancy Information No information present
Event Death Details
Death Date Autopsy Done? Autopsy Results Available?

Katie Ahern Page 2 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Yes No
Lab Data No information present
Other Relevant History
# Start / Stop Date Condition Type / Verbatim / Product Identifier Type / Product Identifier / Coded PT/Description of condition LLT/Indication PT/Reaction PT
Version / Indication / Reaction
1 *See Narrative

Ongoing:
Age:
Units:

Family History
Notes:

Relevant Tests

Current Medical Status


Alcohol Abuse Yes No Unk Metabolic Disease Yes No Unk
Allergic History Yes No Unk Nicotine Use Yes No Unk
Contraceptives Yes No Unk Pacemaker Yes No Unk
Drug Abuse Yes No Unk Physiotherapy Yes No Unk
Immunodeficiency Yes No Unk Radiotherapy Yes No Unk
Implants Yes No Unk Special Diet Yes No Unk
Other Yes No Unk
Patient Notes No information present
Patient Parent Information No information present
Parent Pregnancy Information No information present
Other Relevant History No information present
Product Information
1 Product Name WHO Drug Code Suspect
SYNT001 Concomitant
Treatment
Generic Name
SYNT001
Product Identifier Type Product Identifier Version

Manufacturer Study Drug

Katie Ahern Page 3 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Syntimmune, Inc. SYNT001, Infusion
Formulation
Infusion Drug Not Administered
Indications
Reported Indication Coded Indication
PEMPHIGUS VULGARIS Pemphigus

Substance Information
Substance Name Substance Term ID Version Strength Unit
SYNT001
Product Name Parts Information
Name Part Type Name Part

Dosage Regimens
1 Start Date/Time Stop Date/Time Ongoing
01-AUG-2017 00:00
Duration of Regimen Dose Units 0 0 Frequency
10.00 mg/kg Q Week
Patient Route of Administration Parent Route of Administration Daily Dosage Units Dose Description
Intravenous 10 mg/kg, Q Week
Batch / Lot # Expiration Date Regimen Units
Dosage

Product Details
First Dose Last Dose Duration of Administration Total Dosage Units
01-AUG-2017 00:00
Time Between First Dose/Primary Event Time between Last Dose/Primary Event Total Dose to Gestation Period at Unit
Primary Event Exposure
2 days
Action Taken Taken Previously / Tolerated Dechallenge Results
Dose not changed Unknown / N/A Pos Neg N/A Unk
Rechallenge Results Specialized Product Category
Pos Neg N/A Unk
Batch and lot tested and found within specifications Batch and lot tested and found not within specifications Counterfeit
Drug taken by the father Drug taken beyond expiry date Medication error Misuse

Katie Ahern Page 4 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Occupational exposure Off label use Overdose
Quality Control

Product Notes

2 Product Name WHO Drug Code Suspect


PREDNISONE 000447.01.001 Concomitant
Treatment
Generic Name
PREDNISONE
Product Identifier Type Product Identifier Version

Manufacturer Device Type

Formulation
Drug Not Administered
Indications
Reported Indication Coded Indication
pemphigus Pemphigus

# of Siblings Birth Weight Include in VAERS Block


System Calculated
Substance Information
Substance Name Substance Term ID Version Strength Unit
PREDNISONE
Product Name Parts Information
Name Part Type Name Part

Component Name Component Term ID Version Batch Lot #


Product Delivered by Device Other Mfg Product Text

Lot # Expiration Date Date of Mfr Device Age Units

Katie Ahern Page 5 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Model # Serial # Catalog # Unique Identifier (UDI) #

Date Implanted Date Explanted Improper Use or Storage

Operator of Device If Other Trained User Duration of implantation


Yes No Unk
Malfunction Malfunction Type Manufacturer/Importer Awareness Date
Yes No Unk
Device available for evaluation Returned to manufacturer on

Preliminary Comments

Malfunction Information
# Reported Malfunction Determined Malfunction Listedness Reportable

MedWatch Device Information


Is this a Single-use device that was Reprocessed and Reused on a Patient
Yes No Adverse Event Product Problem
Re-processor Name Type of Follow-up Report
Correction
Address 1 Additional Information
Resp. to FDA Request
Address 2 Device Evaluation

City State Device evaluated by mfr?

Country Postal Code Reason for Non-Evaluation

Fax Other Reason for Non-Evaluation

Email Address

Event Problem Codes Information


Code Patient Problem Code Device Problem
Evaluation Codes Information
Code Evaluation Method Code Evaluation Results Code Evaluation Conclusion
If remedial action initiated, check type Usage of Device
Recall Notification
Repair Inspection 21 USC 360i(f) correction/ removal reporting number

Katie Ahern Page 6 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Replace Patient Monitoring
Relabeling Modification/Adjustment
Other
Additional manufacturer narrative Corrected data

Dosage Regimens/Vaccine Information


1 Start Date/Time Stop Date/Time Ongoing
26-MAY-2017 00:00 02-AUG-2017 00:00
Duration of Regimen Dose Units Block 10 Block 14 Frequency
2 months 8 days 60.00 mg qd
Patient Route of Administration Parent Route of Administration Daily Dosage Units Dose Description Anatomical Location
Oral 60.00 mg 60 mg, qd
Batch / Lot # Expiration Date Regimen Units
Dosage
4140.00 mg
Product Details
First Dose Last Dose Duration of Administration Total Dosage Units
26-MAY-2017 00:00 02-AUG-2017 00:00 2 months 8 days 4140.000000 mg
Time Between First Dose/Primary Event Time between Last Dose/Primary Event Total Dose to Gestation Period at Unit
Primary Event Exposure
2 months 11 days 4 days 4140.000000 mg
Action Taken Taken Previously / Tolerated Dechallenge Results
Unknown / N/A Pos Neg N/A Unk
Rechallenge Results Specialized Product Category
Pos Neg N/A Unk
Batch and lot tested and found within specifications Batch and lot tested and found not within specifications Counterfeit
Drug taken by the father Drug taken beyond expiry date Medication error Misuse
Occupational exposure Off label use Overdose
Vaccine History No information present
Quality Control

Katie Ahern Page 7 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001

Product Notes

3 Product Name WHO Drug Code Suspect


ACETAMINOPHEN 000200.01.009 Concomitant
Treatment
Generic Name
PARACETAMOL
Product Identifier Type Product Identifier Version

Manufacturer Device Type

Formulation
Drug Not Administered
Indications
Reported Indication Coded Indication
premedication Premedication

# of Siblings Birth Weight Include in VAERS Block


System Calculated
Substance Information
Substance Name Substance Term ID Version Strength Unit
PARACETAMOL
Product Name Parts Information
Name Part Type Name Part

Component Name Component Term ID Version Batch Lot #


Product Delivered by Device Other Mfg Product Text

Lot # Expiration Date Date of Mfr Device Age Units

Model # Serial # Catalog # Unique Identifier (UDI) #

Date Implanted Date Explanted Improper Use or Storage

Operator of Device If Other Trained User Duration of implantation


Yes No Unk
Malfunction Malfunction Type Manufacturer/Importer Awareness Date

Katie Ahern Page 8 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Yes No Unk
Device available for evaluation Returned to manufacturer on

Preliminary Comments

Malfunction Information
# Reported Malfunction Determined Malfunction Listedness Reportable

MedWatch Device Information


Is this a Single-use device that was Reprocessed and Reused on a Patient
Yes No Adverse Event Product Problem
Re-processor Name Type of Follow-up Report
Correction
Address 1 Additional Information
Resp. to FDA Request
Address 2 Device Evaluation

City State Device evaluated by mfr?

Country Postal Code Reason for Non-Evaluation

Fax Other Reason for Non-Evaluation

Email Address

Event Problem Codes Information


Code Patient Problem Code Device Problem
Evaluation Codes Information
Code Evaluation Method Code Evaluation Results Code Evaluation Conclusion
If remedial action initiated, check type Usage of Device
Recall Notification
Repair Inspection 21 USC 360i(f) correction/ removal reporting number
Replace Patient Monitoring
Relabeling Modification/Adjustment
Other
Additional manufacturer narrative Corrected data

Dosage Regimens/Vaccine Information


1 Start Date/Time Stop Date/Time Ongoing

Katie Ahern Page 9 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
01-AUG-2017 00:00
Duration of Regimen Dose Units Block 10 Block 14 Frequency
650.00 mg Q Week
Patient Route of Administration Parent Route of Administration Daily Dosage Units Dose Description Anatomical Location
Oral 650 mg, Q Week
Batch / Lot # Expiration Date Regimen Units
Dosage

Product Details
First Dose Last Dose Duration of Administration Total Dosage Units
01-AUG-2017 00:00
Time Between First Dose/Primary Event Time between Last Dose/Primary Event Total Dose to Gestation Period at Unit
Primary Event Exposure
5 days
Action Taken Taken Previously / Tolerated Dechallenge Results
Unknown / N/A Pos Neg N/A Unk
Rechallenge Results Specialized Product Category
Pos Neg N/A Unk
Batch and lot tested and found within specifications Batch and lot tested and found not within specifications Counterfeit
Drug taken by the father Drug taken beyond expiry date Medication error Misuse
Occupational exposure Off label use Overdose
Vaccine History No information present
Quality Control

Product Notes

4 Product Name WHO Drug Code Suspect


DIPHENHYDRAMINE 000004.01.001 Concomitant
Treatment
Generic Name
DIPHENHYDRAMINE

Katie Ahern Page 10 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Product Identifier Type Product Identifier Version

Manufacturer Device Type

Formulation
Drug Not Administered
Indications
Reported Indication Coded Indication
premedication Premedication

# of Siblings Birth Weight Include in VAERS Block


System Calculated
Substance Information
Substance Name Substance Term ID Version Strength Unit
DIPHENHYDRAMINE
Product Name Parts Information
Name Part Type Name Part

Component Name Component Term ID Version Batch Lot #


Product Delivered by Device Other Mfg Product Text

Lot # Expiration Date Date of Mfr Device Age Units

Model # Serial # Catalog # Unique Identifier (UDI) #

Date Implanted Date Explanted Improper Use or Storage

Operator of Device If Other Trained User Duration of implantation


Yes No Unk
Malfunction Malfunction Type Manufacturer/Importer Awareness Date
Yes No Unk
Device available for evaluation Returned to manufacturer on

Preliminary Comments

Malfunction Information
# Reported Malfunction Determined Malfunction Listedness Reportable

MedWatch Device Information

Katie Ahern Page 11 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Is this a Single-use device that was Reprocessed and Reused on a Patient
Yes No Adverse Event Product Problem
Re-processor Name Type of Follow-up Report
Correction
Address 1 Additional Information
Resp. to FDA Request
Address 2 Device Evaluation

City State Device evaluated by mfr?

Country Postal Code Reason for Non-Evaluation

Fax Other Reason for Non-Evaluation

Email Address

Event Problem Codes Information


Code Patient Problem Code Device Problem
Evaluation Codes Information
Code Evaluation Method Code Evaluation Results Code Evaluation Conclusion
If remedial action initiated, check type Usage of Device
Recall Notification
Repair Inspection 21 USC 360i(f) correction/ removal reporting number
Replace Patient Monitoring
Relabeling Modification/Adjustment
Other
Additional manufacturer narrative Corrected data

Dosage Regimens/Vaccine Information


1 Start Date/Time Stop Date/Time Ongoing
01-AUG-2017 00:00
Duration of Regimen Dose Units Block 10 Block 14 Frequency
50.00 mg Q Week
Patient Route of Administration Parent Route of Administration Daily Dosage Units Dose Description Anatomical Location
Oral 50 mg, Q Week
Batch / Lot # Expiration Date Regimen Units
Dosage

Katie Ahern Page 12 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Product Details
First Dose Last Dose Duration of Administration Total Dosage Units
01-AUG-2017 00:00
Time Between First Dose/Primary Event Time between Last Dose/Primary Event Total Dose to Gestation Period at Unit
Primary Event Exposure
5 days
Action Taken Taken Previously / Tolerated Dechallenge Results
Unknown / N/A Pos Neg N/A Unk
Rechallenge Results Specialized Product Category
Pos Neg N/A Unk
Batch and lot tested and found within specifications Batch and lot tested and found not within specifications Counterfeit
Drug taken by the father Drug taken beyond expiry date Medication error Misuse
Occupational exposure Off label use Overdose
Vaccine History No information present
Quality Control

Product Notes

Vaccine Administration Information No information present


Prior Vaccination Adverse Events Information No information present
Event Information
1 Description as Reported
Disease exacerbation (pemphigus vulgaris)
Original Language

Description to be Coded
Disease progression
System Organ Class (SOC) General disorders and administration site conditions (10018065)
High Level Group Term General system disorders NEC (10018073)
High Level Term General signs and symptoms NEC (10018072)
Preferred Term Disease progression (10061818)

Katie Ahern Page 13 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Lower Level Term Disease progression (10061818)
Synonym
Onset Date/Time Onset From Last Dose Stop Date/Time Duration Onset Latency
02-AUG-2017 00:00 12-AUG-2017 00:00 11 days 2 days
Intensity Medical Confirmation by HCP
Grade 3
Country in which Event Occurred Outcome of Event
recovered/resolved

Emergency Room Visit Physician Office Visit


Seriousness Criteria
Death Congenital Anomaly Disability Medically Significant
Hospitalized Life-threatening Intervention Required Other:

Details
Action Taken Study Drug
Dose not changed
Hospitalization Details
Hospital Name City State

Hospitalization Prolonged
2 Description as Reported
Acute Kidney Injury (Secondary to Vancomycin and Zosyn)
Original Language

Description to be Coded
Acute Kidney Injury (Secondary to Vancomycin and Zosyn)
System Organ Class (SOC) Renal and urinary disorders (10038359)
High Level Group Term Renal disorders (excl nephropathies) (10038430)
High Level Term Renal failure and impairment (10038443)
Preferred Term Acute kidney injury (10069339)
Lower Level Term Acute kidney injury (10069339)
Synonym
Onset Date/Time Onset From Last Dose Stop Date/Time Duration Onset Latency
09-AUG-2017 00:00 12-AUG-2017 00:00 4 days 9 days
Intensity Medical Confirmation by HCP

Katie Ahern Page 14 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Grade 2
Country in which Event Occurred Outcome of Event
recovered/resolved

Emergency Room Visit Physician Office Visit


Seriousness Criteria
Death Congenital Anomaly Disability Medically Significant
Hospitalized Life-threatening Intervention Required Other:

Details
Action Taken Study Drug
Dose Not Changed
Hospitalization Details
Hospital Name City State

Hospitalization Prolonged
Event Relationships No information present
Event Assessment
Event (Description as Reported) / NOT USED / License Causality as Reported Causality as Determined Other Causality Source / As Determined Listedness
Source / Method / Result Source / Method / Result Method / Result
Disease progression
(Disease exacerbation (pemphigus vulgaris))
Seriousness: H DIS
Intensity: Grade 3
Duration: 11 days

SYNT001, Infusion - / US (Inv: 132727) / / Not Related (No) / / Not Related (No) Unlisted
SYNT001, Infusion - / US (Inv: 128152) / / Not Related (No) / / Not Related (No) Unlisted
Acute kidney injury
(Acute Kidney Injury (Secondary to Vancomycin
and Zosyn))
Seriousness: H
Intensity: Grade 2
Duration: 4 days

SYNT001, Infusion - / US (Inv: 132727) / / Not Related (No) / / Not Related (No) Unlisted
SYNT001, Infusion - / US (Inv: 128152) / / Not Related (No) / / Not Related (No) Unlisted

Katie Ahern Page 15 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Product - Event Details
Event (Description as Reported) / ()
Disease progression
(Disease exacerbation (pemphigus vulgaris))
SYNT001, Infusion

Acute kidney injury


(Acute Kidney Injury (Secondary to Vancomycin and
Zosyn))
SYNT001, Infusion

Case Analysis
Narrative
Protocol SYNT001-103: A Phase 1b, Multicenter, Open-Label, Safety, Tolerability, and Activity Study of SYNT001 in Subjects with Chronic Pemphigus (Vulgaris or Foliaceus)

Subject 205-001, a 19 year-old African-American male with pemphigus vulgaris (onset date 28-Dec-2016) experienced the serious adverse events of disease exacerbation (pemphigus vulgaris) and acute kidney injury
(secondary to vancomycin and Zosyn). The subject signed informed consent on 18-Jul-2017. The subject began treatment with dose level 1, SYNT001 10 mg/kg/dose on 01-Aug-2017. The subject was in the
treatment phase at the time of the event. Doses were administered weekly for a total of five doses.

The subject's last infusion prior to the onset of event was administered on 01-Aug-2017 (also the first dose). The dose administered was 730 mg intravenous (IV).

On Study Day 01 (02-Aug-2017), the subject was started on Percocet (acetaminophen-oxycodone) for pain in the pemphigus vulgaris lesions. On Study Day 04 (05-Aug-2017), the subject noted that his pemphigus
vulgaris began to worsen with new ocular involvement, drainage from the eyelids bilaterally, and other new lesions on hands, arms, and legs, bilaterally. The patient returned for his infusion on Study Day 07 (08-
Aug-2017) and reported the worsening of lesions. He received the study drug, dose #2 on Study Day 07 per protocol. On Study Day 07 (08-Aug-2017), the subject was admitted to the emergency department after the
infusion, where the subject rated his pain between eight and ten consistently, even following administration of meperidine. Laboratory testing revealed a creatinine result of 0.6-0.7 mg/dL (Normal Range [NR] 0.7 mg/
dL - 1.3 mg/dL). The subject was subsequently admitted to the hospital for further evaluation and treatment. It was determined during hospital admission that the subject failed to notify his physician that he failed to
continue his prescribed prednisone and acyclovir and did not request a refill at his last visit on 01-Aug-2017, which was the likely cause of disease flare. He had previously been prescribed prednisone for his
pemphigus vulgaris, with various dosing regimens and tapers starting December of 2016. Consistent dosing of prednisone was started on 26-May-2017 and the subject had interrupted dosing approximately 31-
Jul-2017. Cultures from the blood were obtained and were negative. Skin cultures returned positive for Methicillin resistant Staphylococcus aureus (MRSA) and Herpes simplex virus (HSV) Type 1 (reported as non-
serious adverse events). The subject was restarted on prednisone and skin lesions showed improvement. Additional treatment included vancomycin, Zosyn, acyclovir, hydromorphone, meperidine, doxycycline,
bacitracin, and oxycodone. On Study Day 08 (09-Aug-2017), laboratory testing revealed a creatinine result of 1.52 mg/dL, and a glomerular filtration rate (GFR) in the normal range (NR >60 mL/min/1.72 m2,
calculation: 175 x [SCr, mg/dL]-1.154 x [Age]-0.203 x [1.210 if African-American]). On Study Day 09 (10-Aug-2017), laboratory testing revealed a creatinine result of 3.23 mg/dL, and a decreased GFR of 30 mL/
min/1.73 m2. That same date, a renal ultrasound showed no evidence of obstruction. The subject was diagnosed with acute kidney injury (AKI). The treating physician considered the vancomycin and Zosyn as the
likely cause of the AKI. Both medications were discontinued, and it was decided to monitor laboratory results for signs of improvement before discharging the subject from the hospital. Treatment for the acute kidney
injury included intravenous sodium chloride. On Study Day 10 (11-Aug-2017), laboratory testing revealed a creatinine of 3.42 mg/dL, and a GFR of 28 mL/min/1.73 m2. On Study Day 11 (12-Aug-2017), laboratory
testing revealed a creatinine of 3.38 mg/dL and GFR of 29 mL/min/1.73 m2. It was reported that the subject had significantly diuresed with no electrolyte imbalances and excellent oral fluid intake, and that kidney
function appeared to be improving. That same day, the events of disease exacerbation (pemphigus vulgaris) and acute kidney injury (secondary to vancomycin and Zosyn) were considered resolved, and the subject
was discharged from the hospital with oral doxycycline, prednisone, acyclovir; artificial tears, ophthalmic bacitracin, and plans to have serum creatinine re-checked at his follow-up appointment to ensure continued
improvement. It was the opinion of the investigator that the AKI had extended the patient's hospitalization. No action was taken with the study drug due to these events. The subject was continued in the study.

Medical history included pain related to pemphigus and anxiety.

Concomitant medications (taken at the time of the event) included prednisone, acetaminophen, and diphenhydramine.

The investigator considered the event of disease exacerbation (pemphigus vulgaris) as Grade 3 intensity and unrelated to SYNT001. The investigator also reported the event of disease exacerbation (pemphigus

Katie Ahern Page 16 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
vulgaris) as resulting in substantial disruption of the ability to conduct normal life functions as the subject experienced severe pain, which hindered his ability to lift his arms to change clothes, disruption of normal
skin function causing decreased oral fluid intake as the pain was too severe to get up to use the restroom, and a withdrawn affect. The investigator considered the event of acute kidney injury (secondary to
vancomycin and Zosyn) as Grade 2 intensity and unrelated to SYNT001. The Sponsor considered the events of disease exacerbation (pemphigus vulgaris) and acute kidney injury (secondary to vancomycin and
Zosyn) as unrelated to SYNT001.

Case Comment

Case Serious Notes:


Yes No
Overall Case Causality Notes:
Yes No Unk
Listedness Determination Notes:
Unlisted
Case Outcome
recovered/resolved

MedWatch Info
B. Adverse event or product problem C. Suspect medication(s)
1. Adverse Event and / or Product Problem 9. NDC # :
F. For use by user facility/importer-devices
1. Check one User Facility Importer Suppress Block F Printing
G. All manufacturers
3. Report Source (check all that apply)
Foreign Literature Health Professional Company Representative Study Consumer
User Facility Distributor Other:
5. STN # Pre-1938 OTC product

Contact Log
# Date Due Code / Description Group / User Date Sent
1 25-SEP-2017 Followup02 --Any-- 25-SEP-2017
Follow-up 02 --Any--
2 26-OCT-2017 Followup03 --Any-- 24-OCT-2017
Follow-up 03 --Any--
3 26-JUL-2018 Followup04 --Any-- 26-JUL-2018
Follow-up 04 --Any--

Katie Ahern Page 17 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Routing Comments
# Date / User Comment
62 30-JUL-2018 15:18 Case Closed. case re-closed
Katie Ahern
61 30-JUL-2018 15:17 Case routed from Distribution to Sponsor by Katie Ahern to Case Repository-Not Expedited, Any
Katie Ahern
60 26-JUL-2018 16:34 Case routed from Medical Review by Katie Ahern to Distribution to Sponsor, (Any)
Katie Ahern
59 26-JUL-2018 16:33 Case Locked. final
Katie Ahern
58 26-JUL-2018 15:59 Case routed from Manager QC Review by Katie Ahern to Medical Review, Any
Katie Ahern
57 25-JUL-2018 14:58 Case routed from Manager QC Review by Katie Ahern to Manager QC Review, (Any)
Katie Ahern
56 25-JUL-2018 14:33 Case routed from Manager QC Review by Paul Farmwald to Manager QC Review, (Any)
Paul Farmwald
55 25-JUL-2018 14:32 Case routed from QC by Paul Farmwald to Manager QC Review, Any
Paul Farmwald
54 17-JUL-2018 15:52 Case routed from Case Processing by Katie Ahern to QC, (Any)
Katie Ahern
53 17-JUL-2018 15:44 Reporting scheduling from manual activation

52 17-JUL-2018 15:43 Case routed from Case Repository-Not Expedited by Katie Ahern to Case Processing, (Any)
Katie Ahern
51 17-JUL-2018 15:36 Case Reopened. additional information received
Katie Ahern
50 09-MAR-2018 12:21 Case Closed. re-closed after updates per sponsor request
Katie Ahern
49 09-MAR-2018 12:20 Case routed from Distribution to Sponsor by Katie Ahern to Case Repository-Not Expedited, Any
Katie Ahern
48 09-MAR-2018 11:03 Case Locked. final
Katie Ahern
47 01-MAR-2018 11:06 Case routed from Distribution to Sponsor by Katie Ahern to Distribution to Sponsor, (Any)
Katie Ahern

Katie Ahern Page 18 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
46 01-MAR-2018 11:05 Case Reopened. update to narrative per sponsor request
Katie Ahern
45 25-OCT-2017 11:01 Case Closed. case closed with MM approval
Katie Ahern
44 25-OCT-2017 10:58 Case Locked. case lock
Katie Ahern
43 25-OCT-2017 10:57 Case Unlocked. add closure date
Katie Ahern
42 24-OCT-2017 13:03 Case routed from Distribution to Sponsor by Katie Ahern to Distribution to Sponsor, Katie Ahern
Katie Ahern
41 24-OCT-2017 12:58 Case Locked with significant follow up on 12-OCT-2017. case lock
Katie Ahern
40 24-OCT-2017 12:55 Case routed from Medical Review by Katie Ahern to Distribution to Sponsor, Any
Katie Ahern
39 24-OCT-2017 12:54 Case routed from Manager QC Review by Katie Ahern to Medical Review, Any
Katie Ahern
38 20-OCT-2017 14:13 Case routed from QC by Victoria Kindred to Manager QC Review, Any
*Victoria Kindred
37 18-OCT-2017 11:27 Case routed from Case Processing by Katie Ahern to QC, (Any)
Katie Ahern
36 16-OCT-2017 09:31 Case routed from Case Repository-Not Expedited by Katie Ahern to Case Processing, (Any)
Katie Ahern
35 16-OCT-2017 09:23 Case Unlocked. follow-up received
Katie Ahern
34 25-SEP-2017 17:15 Case routed from Distribution to Sponsor by Katie Ahern to Case Repository-Not Expedited, (Any)
Katie Ahern
33 25-SEP-2017 16:46 Case routed from Distribution to Sponsor by Katie Ahern to Distribution to Sponsor, Katie Ahern
Katie Ahern
32 25-SEP-2017 16:46 Case Locked. final
Katie Ahern
31 25-SEP-2017 16:40 Case Unlocked. edit report
Katie Ahern
30 25-SEP-2017 15:01 Case routed from Distribution to Sponsor by Katie Ahern to Distribution to Sponsor, Katie Ahern
Katie Ahern

Katie Ahern Page 19 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
29 25-SEP-2017 15:00 Case Locked with significant follow up on 11-SEP-2017. final
Katie Ahern
28 25-SEP-2017 14:57 Case routed from Medical Review by Katie Ahern to Distribution to Sponsor, Any
Katie Ahern
27 25-SEP-2017 14:57 Case routed from Manager QC Review by Katie Ahern to Medical Review, Any
Katie Ahern
26 22-SEP-2017 13:25 Case routed from Manager QC Review by Katie Ahern to Manager QC Review, Amanda Taliaferro
Katie Ahern
25 22-SEP-2017 11:41 Case routed from Manager QC Review by Katie Ahern to Manager QC Review, Amanda Taliaferro
Katie Ahern
24 22-SEP-2017 10:09 Case routed from QC by Amanda Taliaferro to Manager QC Review, Any
Amanda Taliaferro
23 21-SEP-2017 10:31 Case routed from QC by Katie Ahern to QC, (Any)
Katie Ahern
22 21-SEP-2017 08:51 Case routed from Case Processing by Katie Ahern to QC, (Any)
Katie Ahern
21 20-SEP-2017 14:59 Case routed from Case Repository-Not Expedited by Katie Ahern to Case Processing, (Any)
Katie Ahern
20 20-SEP-2017 14:53 Case Unlocked. follow-up received
Katie Ahern
19 08-SEP-2017 16:54 Case routed from Distribution to Sponsor by Kelly McIntosh to Case Repository-Not Expedited, Any
*Kelly McIntosh
18 08-SEP-2017 16:42 Case Locked with significant follow up on 25-AUG-2017. locking case
*Kelly McIntosh
17 08-SEP-2017 16:41 Case routed from Manager QC Review by Kelly McIntosh to Distribution to Sponsor, Any
*Kelly McIntosh
16 07-SEP-2017 15:47 Case routed from QC by Erika Tonne to Manager QC Review, Any
Erika Tonne
15 07-SEP-2017 09:50 Case routed from Case Processing by Kelly McIntosh to QC, Any
*Kelly McIntosh
14 25-AUG-2017 14:44 Case routed from Case Repository-Not Expedited by Kelly McIntosh to Case Processing, Any
*Kelly McIntosh
13 25-AUG-2017 14:44 Case Unlocked. follow-up
*Kelly McIntosh

Katie Ahern Page 20 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
12 22-AUG-2017 15:30 Case routed from Distribution to Sponsor by Kelly McIntosh to Case Repository-Not Expedited, Any
*Kelly McIntosh
11 22-AUG-2017 15:11 Case Locked. locking case
*Kelly McIntosh
10 22-AUG-2017 15:09 Case Unlocked. unlocking
*Kelly McIntosh
9 22-AUG-2017 15:07 Case Locked. locking case
*Kelly McIntosh
8 22-AUG-2017 15:04 Case Unlocked. unlocking
*Kelly McIntosh
7 22-AUG-2017 14:53 Case Locked. locking case
*Kelly McIntosh
6 22-AUG-2017 14:53 Case routed from Medical Review by Kelly McIntosh to Distribution to Sponsor, Any
*Kelly McIntosh
5 22-AUG-2017 14:49 Case routed from Manager QC Review by Kelly McIntosh to Medical Review, Any
*Kelly McIntosh
4 22-AUG-2017 08:02 Case routed from QC by Donna McLaughlin to Manager QC Review, Any
Donna McLaughlin
3 21-AUG-2017 10:32 Case routed from Case Processing by Kelly McIntosh to QC, Any
*Kelly McIntosh
2 16-AUG-2017 11:39 Case routed from Data Entry by Kelly McIntosh to Case Processing, Any
*Kelly McIntosh
1 16-AUG-2017 11:37 Automated initial case routing set responsible group to "Data Entry Group 2".
*Kelly McIntosh
Action Items
# Date Open Code / Description Group / User Due Completed
1 --Any-- 22-AUG-2017
Query to site: Discharge summary and SAE term clarification --Any--
2 --Any-- 08-SEP-2017
Query to site: SAE term clarification lab units and normal ranges --Any--
3 --Any-- 24-OCT-2017
Case closed. Awaiting updated PI signature for these events. Still needs CRA reconciliation --Any--
Case Lock / Close
Lock Date System Close Date Locked or Closed By

Katie Ahern Page 21 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
30-JUL-2018 Katie Ahern
Notes
case re-closed
Notes and Attachments No information present
References No information present
Regulatory Reports
# Seq Destination / Report Type License Type / Responsibility (User User Group) Date Scheduled / Date Date Due / Date Submitted
License # Generated
1 Initial Syntimmune, Inc. (PT) Invest. Kelly McIntosh 21-AUG-2017 22-AUG-2000
US FDA MedWatch 3500A Drug 132727 22-AUG-2017 15:11
Scheduling / Submission Notes
Due: 22Aug2017
Submission Required Determined On Determined By
Yes No 22-AUG-2017 *Kelly McIntosh
Reason for Non-Submission
non-expedited
Local Comment

Report Transmission Information


Report Form Fax Number / Recipient Date # of Pages Sender
Name Created
Agency Name Recipient Company Date Sent Attempts Status
2 Initial Syntimmune, Inc. (PT) Invest. Kelly McIntosh 24-AUG-2017 08-SEP-2000
US FDA MedWatch 3500A Drug 132727 08-SEP-2017 16:42
Scheduling / Submission Notes
Due: 08Sep2017
Submission Required Determined On Determined By
Yes No 08-SEP-2017 *Kelly McIntosh
Reason for Non-Submission
Non-expedited
Local Comment

Report Transmission Information


Report Form Fax Number / Recipient Date # of Pages Sender
Name Created
Agency Name Recipient Company Date Sent Attempts Status

Katie Ahern Page 22 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
3 Initial Syntimmune, Inc. (PT) Invest. Katie Ahern 24-SEP-2017 25-SEP-2000
US FDA MedWatch 3500A Drug 132727 25-SEP-2017 16:46
Scheduling / Submission Notes
due: 25-Sep-2017
Submission Required Determined On Determined By
Yes No 25-SEP-2017 Katie Ahern
Reason for Non-Submission
Not expedited
Local Comment

Report Transmission Information


Report Form Fax Number / Recipient Date # of Pages Sender
Name Created
Agency Name Recipient Company Date Sent Attempts Status
4 Initial Syntimmune, Inc. (PT) Invest. Katie Ahern 15-OCT-2017 26-OCT-2000
US FDA MedWatch 3500A Drug 132727 24-OCT-2017 12:58
Scheduling / Submission Notes
Due: 26-Oct-2017
Submission Required Determined On Determined By
Yes No 25-OCT-2017 Katie Ahern
Reason for Non-Submission
not expedited
Local Comment

Report Transmission Information


Report Form Fax Number / Recipient Date # of Pages Sender
Name Created
Agency Name Recipient Company Date Sent Attempts Status
5 Initial Syntimmune, Inc. (PT) Invest. Katie Ahern 28-FEB-2018 09-MAR-2018
US FDA MedWatch 3500A Drug 132727 09-MAR-2018 11:03
Scheduling / Submission Notes
Manual:
Submission Required Determined On Determined By
Yes No 09-MAR-2018 Katie Ahern
Reason for Non-Submission
not expedited

Katie Ahern Page 23 of 24


Case Record
20-MAR-2019 08:45:01 PM
Case Number: 2017USSYNT0010001
Local Comment

Report Transmission Information


Report Form Fax Number / Recipient Date # of Pages Sender
Name Created
Agency Name Recipient Company Date Sent Attempts Status
6 Initial Syntimmune, Inc. (PT) Invest. Katie Ahern 16-JUL-2018 26-JUL-2000
US FDA MedWatch 3500A Drug 132727 26-JUL-2018 16:33
Scheduling / Submission Notes
Manual: 26-Jul-2018
Submission Required Determined On Determined By
Yes No 30-JUL-2018 Katie Ahern
Reason for Non-Submission
Not expedited
Local Comment

Report Transmission Information


Report Form Fax Number / Recipient Date # of Pages Sender
Name Created
Agency Name Recipient Company Date Sent Attempts Status
Justifications No information present

Katie Ahern Page 24 of 24