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CIOMS FORM
SUSPECT ADVERSE REACTION REPORT
CONTROL No : 40054-1076-2 (4)
I. REACTION INFORMATION
1. PATIENT CODE
SE
1a. COUNTRY
2. DATE OF BIRTH
GERMANY
Day
Month
Year
21
06
1938
2a. AGE
3. SEX 4-6. REACTION ONSET
73 years
F
Day
Month
Year
07
03
2012
8-12. CHECK ALL APPROPRIATE
TO ADVERSE REACTION
PATIENT DIED
7+13 DESCRIBE REACTION(S) (including relevant tests/lab data)
TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack (10044390)) - resolved/recovered
LIFE THREATENING
X INVOLVED OR PROLONGED
INPATIENT HOSPITALISATION
DYSARTHRIA (Dysarthria (10013887)) - resolved/recovered
ATAXIA (Ataxia (10003591)) - resolved/recovered
HYPERVENTILATION TETANIA (Hyperventilation tetany (10059615)) - resolved/recovered
INVOLVED PERSISTENCE OR
SIGNIFICANT DISABILITY
OR INCAPACITY
This report was received from an investigator participating in EORTC clinical trial study: 40054 (PETACC-6). The world wide
case ID of this case is: DE-EORTC-40054-1076-2.
CONGENITAL ANOMALY
A 73 years old female subject with diagnosed Rectal cancer and with medical history of hypertension and hypothyroidism
OTHER MEDICALLY IMPORTANT
CONDITION
presented with:
SUSPICION OF TRANSIENT ISCHAEMIC ATTACK on 07/03/2012.
The investigator considered this case as serious as event met the seriousness criteria of inpatient hospitalization.
The subject received first administration of Xeloda on 17/08/2011, Eloxatin on 17/08/2011, Radiotherapy on 17/08/2011,
Surgery on 02/11/2011.
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
3177
1076
24c. DATE RECEIVED
10/04/2012
DATE OF THIS REPORT
13/04/2012
24b. CONTROL NO
40054-1076-2 (4)
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 40054-1076-2 (4)
Page :
2
Date :
13/04/2012
Control No :
40054-1076-2(4)
I. REACTION INFORMATION
The subject received the last administration prior to onset of SAE of Xeloda (1500 mg) on 29/02/2012, Eloxatin (230.1 mg) on 07/03/2012,
Radiotherapy (1.8 Gy) on 23/09/2011, Surgery on 02/11/2011.
The following treatments were given for the adverse event: Acetylsalicylic acid (100 mg), Calcium (1000 mg).
Concomitant medications: Hct (12.5 mg), Enalapril (10 mg), L-thyroxin (100 µg), Bisoprolol (5 mg), Mcp, Pantozol.
Following examinations were performed: Brain computerised tomography: 07/03/2012 (Conclusions not reported yet), Neurological examination:
07/03/2012 (Conclusions not reported yet), Leukocyte count NOS: 07/03/2012 (4.9 10E9/L), Hemoglobin: 07/03/2012 (10.4 g/dl), Thrombocyte
count: 07/03/2012 (144 10E9/L), C-reactive protein: 07/03/2012 (8.6 mg/L), MRI: 09/03/2012 (Conclusions not reported yet), Ultrasound Doppler:
08/03/2012 (Conclusions not reported yet).
There is a reasonable possibility that SUSPICION OF TRANSIENT ISCHAEMIC ATTACK was related to Eloxatin and this was unexpected.
The outcome at the time of this report:
SUSPICION OF TRANSIENT ISCHAEMIC ATTACK was resolved/recovered on 07/03/2012.
Investigators’ description of the SAE :
Suspicion of TIA after Oxaliplatin.
Dysarthria, ataxia, hyperventilation tetania
A follow-up report was received on 20/03/2012:
The diagnosis of TRANSIENT ISCHAEMIC ATTACK (TIA) on 07/03/2012 was clinically confirmed.
Concomitant medications: Hct (12.5 mg), Enalapril (10 mg), L-thyroxin (100 µg), Bisoprolol (5 mg), Mcp (10 mg), Pantozol (40 mg).
Following examinations were performed: Brain computerised tomography : 07/03/2012 (Temporaparietal hypodensity on the right side ->
microangiopathic lesion is possible. No evidence of recent ischaemia.), Neurological examination : 07/03/2012 (At the time of examination, no
paresis, no sensible deficit -> TIA is possible but hypodensity in the brain without context of the TIA.) , Leukocyte count NOS : 07/03/2012 (4.9
10E9/L), Hemoglobin : 07/03/2012 (10.4 g/dl), Thrombocyte count : 07/03/2012 (144 10E9/L), C-reactive protein : 07/03/2012 (8.6 mg/L), MRI :
09/03/2012 (Parietotemporal hypodensity is very likely an old lacunar (= small) infarction of the media area. No evidence of fresh ischemia,
significant microangiopathy.) , Ultrasound Doppler : 08/03/2012 (No evidence of significant plaques in the carotis arteria left and right.)
There is a reasonable possibility that TRANSIENT ISCHAEMIC ATTACK was related to Eloxatin and this was unexpected.
The outcome at the time of this report :
TRANSIENT ISCHAEMIC ATTACK was resolved on 07/03/2012.
Investigators’ description of the SAE :
Follow-up (20/03/2012): The events Dysarthria , Ataxia , Hyperventilation tetania are not symptoms/consequences of the transient ischaemic
attack. They are independent symptoms or symptoms as result of the TIA (a.e. anxiety). The diagnosis of TIA was clinically confirmed. Patient
should only be withdrawn from Oxaliplatin treatment. Patient should not be withdrawn from study. The investigator confirmed that 28 fractions of
radiotherapy were given up to 23/09/2011 at a dose of 1.8 Gy per fraction (adding up to a total of 50.4 Gy). Capecitabine strarts on day 1
(17/08/2011) in the evening with 1750 mg. Then continued day 2 to 14 twice a day with 1750 mg, on day 15 only in the morning with 1750 mg.
The start date intake of Bisoprolol, L-thyroxin, Pantozol is unknown.
A follow-up reports were received on 30/03/2012 and 10/04/2012:
The investigator explained the events dysarthria, hypoventilation tetany and ataxia could be (known) side effects of Oxaliplatin. The combination
of all symptoms at the same point in time was the essential reason for hospitalization. The patient did not experience anxiety.
The investigator clarified that Capecitabine started on day 1 in the evening with 1500 mg. Then continued day 2 to 14 twice a day with 1500 mg,
on day 15 only in the morning with 1500 mg. Due to the SAE, Capecitabine was started back on 08/03/2012.
As the events Dysarthria , Ataxia , Hyperventilation tetany are not symptoms/consequences of the transient ischaemic attack, but are
independent symptoms and as the combination of these symptoms at the same point in time was the essential reason for hospitalization, these
events were added as SAE term.
A 73 years old female subject with diagnosed Rectal cancer and with medical history of hypertension and hypothyroidism presented with:
SUSPICION OF TRANSIENT ISCHAEMIC ATTACK on 07/03/2012,
DYSARTHRIA on 07/03/2012,
ATAXIA on 07/03/2012,
HYPERVENTILATION TETANIA on 07/03/2012.
There is a reasonable possibility that TRANSIENT ISCHAEMIC ATTACK was related to Eloxatin and this was unexpected.
There is a reasonable possibility that DYSARTHRIA was related to Eloxatin and this was expected.
There is a reasonable possibility that ATAXIA was related to Eloxatin and this was expected.
There is a reasonable possibility that HYPERVENTILATION TETANIA was related to Eloxatin and this was unexpected.
The combination of these events at the same point is time was unexpected.
CIOMS generated with SAfE v1.2.0.530
Appendix for 40054-1076-2 (4)
Page :
3
Date :
13/04/2012
Control No :
40054-1076-2(4)
The outcome at the time of this report:
TRANSIENT ISCHAEMIC ATTACK was resolved on 07/03/2012,
DYSARTHRIA was resolved on 07/03/2012,
ATAXIA was resolved on 07/03/2012,
HYPERVENTILATION TETANIA was resolved on 07/03/2012.
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) :
17/08/2011 to 29/02/2012 (197 Days)
Therapy ongoing :
2. Eloxatin [Oxaliplatin]
Therapy 1
Dose :
230.1 mg (1 in 3 Weeks)
Route of Admin :
Intravenous (not otherwise specified)
Indication for Use :
RECTAL CANCER
Dates (Duration) :
17/08/2011 to 07/03/2012 (204 Days)
Therapy ongoing :
3. Radiotherapy
Therapy 1
Dose :
1.8 Gy (5 in 7 Days)
Route of Admin :
Indication for Use :
RECTAL CANCER
Dates (Duration) :
17/08/2011 to 23/09/2011 (38 Days)
Therapy ongoing :
No
4. Surgery
Therapy 1
Dose :
Route of Admin :
Indication for Use :
RECTAL CANCER
Dates (Duration) :
02/11/2011 to 02/11/2011 (1 Days)
Therapy ongoing :
No
III.22 CONCOMITANT DRUG(S)
1. Hct [Hydrochlorothiazide]
Therapy 1
Dose :
12.5 mg (1 in 1 Days)
Route of Admin :
Oral
Indication for Use :
EDEMA
Dates (Duration) :
15/02/2012 to Unknown
Therapy ongoing :
Yes
2. Enalapril [Enalapril maleate]
Therapy 1
Dose :
10 mg (1 in 1 Days)
Route of Admin :
Oral
Indication for Use :
HYPERTENSION
Dates (Duration) :
15/02/2012 to Unknown
Therapy ongoing :
Yes
3. L-thyroxin [Levothyroxine sodium]
Therapy 1
Dose :
100 µg (1 in 1 Days)
CIOMS generated with SAfE v1.2.0.530
Appendix for 40054-1076-2 (4)
Route of Admin :
Oral
Indication for Use :
HYPOTHYROIDISM
Dates (Duration) :
Unknown to Unknown
Therapy ongoing :
Yes
Page :
4
Date :
13/04/2012
Control No :
40054-1076-2(4)
4. Bisoprolol [Bisoprolol fumarate]
Therapy 1
Dose :
5 mg (2 in 1 Days)
Route of Admin :
Oral
Indication for Use :
HYPERTENSION
Dates (Duration) :
Unknown to Unknown
Therapy ongoing :
Yes
5. Mcp [Metoclopramide]
Therapy 1
Dose :
10 mg (3 in 1 Days)
Route of Admin :
Oral
Indication for Use :
PROPHYLAXIS NAUSEA
Dates (Duration) :
13/09/2011 to Unknown
Therapy ongoing :
Yes
6. Pantozol [Pantoprazole sodium sesquihydrate]
Therapy 1
Dose :
40 mg (1 in 1 Days)
Route of Admin :
Oral
Indication for Use :
PROPHYLAXIS FOR GASTROINTESTINAL ULCER
Dates (Duration) :
Unknown to Unknown
Therapy ongoing :
Yes
III.23 RELEVANT HISTORY
Rectal cancer
Hypertension
Hypothyroidism
ADDITIONAL INFORMATION
Lab Result(s) :
Test :
LLT :
Date :
Test Result :
1. CCT
Brain computerised tomography
07/03/2012
Temporaparietal hypodensity on the right side -> microangiopathic
lesion is possible.
No evidence of recent ischaemia.
2. Neurological council
Neurological examination
07/03/2012
At the time of examination, no paresis, no sensible deficit -> TIA is
possible but hypodensity in the brain without context of the TIA.
3. Leukocytes
Leukocyte count NOS
07/03/2012
4.9 10E9/L
4. Hemoglobin
Hemoglobin
07/03/2012
10.4 g/dl
5. Thrombocytes
Thrombocyte count
07/03/2012
144 10E9/L
6. CRP
C-reactive protein
07/03/2012
8.6 mg/L
7. MRI
MRI
09/03/2012
Parietotemporal hypodensity is very likely an old lacunar (= small)
infarction of the media area. No evidence of fresh ischemia, significant
microangiopathy.
8. Duplex sonography
Ultrasound Doppler
08/03/2012
No evidence of significant plaques in the carotis arteria left and right.
CIOMS generated with SAfE v1.2.0.530