Download cioms form suspect adverse reaction report

CIOMS FORM
SUSPECT ADVERSE REACTION REPORT
CONTROL No : 40054-1074-3 (1)
I. REACTION INFORMATION
1. PATIENT CODE
J-S
1a. COUNTRY
2. DATE OF BIRTH
BELGIUM
Day
Month
Year
24
04
1955
2a. AGE
3. SEX 4-6. REACTION ONSET
56 years
F
Day
Month
Year
27
01
2012
8-12. CHECK ALL APPROPRIATE
TO ADVERSE REACTION
X PATIENT DIED
7+13 DESCRIBE REACTION(S) (including relevant tests/lab data)
LIFE THREATENING
SUDDEN DEATH (Sudden death (10042434)) - Fatal
This report was received from an investigator participating in EORTC clinical trial study: 40054 (PETACC-6) and refers to a
56 years old female subject, with diagnosed Rectal cancer. The world wide case ID of this case is:
BE-EORTC-40054-1074-3.
INVOLVED OR PROLONGED
INPATIENT HOSPITALISATION
INVOLVED PERSISTENCE OR
SIGNIFICANT DISABILITY
OR INCAPACITY
The 56 years old female subject had a significant past medical history of heart failure (after transfusion of packed cells) for
which she was hospitalized from 16/01/2012 to 19/01/2012. Cardiopulmonary investigation was reassuring.
CONGENITAL ANOMALY
The subject presented with SUDDEN DEATH on 27/01/2012.
OTHER MEDICALLY IMPORTANT
CONDITION
The investigator considered this case as serious as event met the seriousness criteria of death.
The subject received the following multimodal therapy:
First administration of Xeloda on 24/08/2011, Radiotherapy on 24/08/2011, Surgery on 15/11/2011.
Last administration prior to onset of SAE of Xeloda (1500 mg) on 27/01/2012, Radiotherapy (1.8 Gy) on 29/09/2011, Surgery
on 15/11/2011.
See end of event in appendix
II. STUDY TREATMENT INFORMATION
14. SUSPECT DRUG(S) (include generic name)
20. DID REACTION ABATE
AFTER STOPPING DRUG ?
See appendix
Yes
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
See appendix
See appendix
See appendix
18. THERAPY DATES (from/to)
19. THERAPY DURATION
See appendix
See appendix
III. CONCOMITANT DRUG(S) AND HISTORY
22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction)
See appendix
23. RELEVANT HISTORY (e.g diagnostics allergics, pregnancy with last month of period, etc.)
See appendix
IV. REPORTER INFORMATION
24a. NAME AND ADDRESS
EORTC
Avenue E. Mounier 83, bte 11
Brussels 1200 BELGIUM
EUDRACT No :
Study No :
Center No :
Patient No :
2006-006532-21
40054
151
1074
24c. DATE RECEIVED
10/02/2012
DATE OF THIS REPORT
10/02/2012
24b. CONTROL NO
40054-1074-3 (1)
24d. REPORT SOURCE
X STUDY
LITERATURE
HEALTH PROFESSIONAL
25a. REPORT TYPE
X FOLLOW-UP
INITIAL
X NA
21. DID REACTION REAPPEAR
AFTER REINTRODUCTION ?
Yes
17. INDICATION(S) FOR USE
No
No
X NA
Appendix for 40054-1074-3 (1)
Page :
2
Date :
10/02/2012
Control No :
40054-1074-3(1)
I. REACTION INFORMATION
No treatment was given for the adverse event.
Concomitant medications: Asaflow (80 mg), Simvastatine (20 mg), Metformin (875 mg), Pantomed (20 mg), Preterax (1 DF), Lysanxia (20 mg),
Nortrilen (25 mg), Solian (100 mg), Sipralexa (20 mg), Torrem (5 mg).
No relevant lab tests or examinations were performed regarding this SAE.
There is a reasonable possibility that SUDDEN DEATH was related to all of the study treatment and this was unexpected for all of them.
The outcome at the time of this report:
The patient died on 27/01/2012, reported cause of death was: Sudden death.
Autopsy status is unknown.
Follow-up information was received on 10/02/2012:
The investigator reassessed the relationship between the study treatment and the event. Of the study treatments, only Capecitabine was taken
on the morning of the patient's death (also other drugs). The relationship to Capecitabine is unlikely, but possible. The event was unrelated to
radiotherapy and protocol surgery.
Additional medical history was provided: the patient had a depression, which was inactive (with medication) at the start of the study.
The investigator clarified that no autopsy was performed.
Investigators’ description of the SAE :
Found death at home on January 27th - 6 PM.
Follow-up (10/02/2012): Start dates of Preterax, Asaflow, Metformin, Simvastatin, Pantomed, Lysanxia, Nortrilen, Solian and Sipralexa are
unknown.
Schedules of Preterax, Asaflow, Simvastatin, Pantomed, Solian and Sipralexa are unknown.
II. STUDY TREATMENT INFORMATION
1. Xeloda [Capecitabine]
Therapy 1
Dose :
1500 mg (2 in 1 Days)
Route of Admin :
Oral
Indication for Use :
RECTAL CANCER
Dates (Duration) :
24/08/2011 to 27/01/2012 (157 Days)
Therapy ongoing :
No
Dose :
1.8 Gy (5 in 7 Days)
2. Radiotherapy
Therapy 1
Route of Admin :
Indication for Use :
RECTAL CANCER
Dates (Duration) :
24/08/2011 to 29/09/2011 (37 Days)
Therapy ongoing :
No
3. Surgery
Therapy 1
Dose :
Route of Admin :
Indication for Use :
RECTAL CANCER
Dates (Duration) :
15/11/2011 to 15/11/2011 (1 Days)
Therapy ongoing :
No
III.22 CONCOMITANT DRUG(S)
1. Asaflow [Acetylsalicylic acid]
Therapy 1
Dose :
80 mg
Route of Admin :
Oral
Indication for Use :
PROPHYLAXIS CARDIAC
Dates (Duration) :
Unknown to 27/01/2012
Therapy ongoing :
No
CIOMS generated with SAfE v1.2.0.530
Appendix for 40054-1074-3 (1)
Page :
3
Date :
10/02/2012
Control No :
40054-1074-3(1)
2. Simvastatine [Simvastatin]
Therapy 1
Dose :
20 mg
Route of Admin :
Oral
Indication for Use :
HYPERCHOLESTEROLAEMIA
Dates (Duration) :
Unknown to 27/01/2012
Therapy ongoing :
No
3. Metformin [Metformin]
Therapy 1
Dose :
875 mg (3 in 1 Days)
Route of Admin :
Oral
Indication for Use :
DIABETES
Dates (Duration) :
Unknown to 27/01/2012
Therapy ongoing :
No
4. Pantomed [Pantoprazole sodium sesquihydrate]
Therapy 1
Dose :
20 mg
Route of Admin :
Oral
Indication for Use :
GASTROOESOPHAGEAL REFLUX
Dates (Duration) :
Unknown to 27/01/2012
Therapy ongoing :
No
5. Preterax [Indapamide, Perindopril Arginine]
Therapy 1
Dose :
1 DF
Route of Admin :
Oral
Indication for Use :
HYPERTENSION
Dates (Duration) :
Unknown to 27/01/2012
Therapy ongoing :
No
6. Lysanxia [Prazepam]
Therapy 1
Dose :
20 mg (3 in 1 Days)
Route of Admin :
Oral
Indication for Use :
DEPRESSION
Dates (Duration) :
Unknown to 27/01/2012
Therapy ongoing :
No
7. Nortrilen [Nortriptyline hydrochloride]
Therapy 1
Dose :
25 mg (4 in 1 Days)
Route of Admin :
Oral
Indication for Use :
DEPRESSION
Dates (Duration) :
Unknown to 27/01/2012
Therapy ongoing :
No
8. Solian [Amisulpride]
Therapy 1
Dose :
100 mg
Route of Admin :
Oral
Indication for Use :
DEPRESSION
Dates (Duration) :
Unknown to 27/01/2012
Therapy ongoing :
No
9. Sipralexa [Escitalopram]
Therapy 1
Dose :
20 mg
Route of Admin :
Oral
CIOMS generated with SAfE v1.2.0.530
Appendix for 40054-1074-3 (1)
Indication for Use :
DEPRESSION
Dates (Duration) :
Unknown to 27/01/2012
Therapy ongoing :
No
Page :
4
Date :
10/02/2012
Control No :
40054-1074-3(1)
10. Torrem [Torasemide]
Therapy 1
Dose :
5 mg (2 in 1 Days)
Route of Admin :
Oral
Indication for Use :
EDEMA
Dates (Duration) :
18/01/2012 to 27/01/2012 (10 Days)
Therapy ongoing :
No
III.23 RELEVANT HISTORY
Rectal cancer
Heart failure (16/01/2012 to 19/01/2012)
Depression
CIOMS generated with SAfE v1.2.0.530