Guidelines on the collection verification and submission of reports on adverse events reactions arising during clinical trials, , published by Turkish Medicine and Medical Device Agency

1. GUIDELINES ON THE COLLECTION, VERIFICATION AND
SUBMISSION OF REPORTS ON ADVERSE EVENTS/REACTIONS
ARISING DURING CLINICAL TRIALS
1.
10.05.2013
SCOPE
This guidance pertains to collection, verification, submission and decoding procedures of reports
on adverse events/reactions reports arising during clinical trials in our country.
2.
DEFINITIONS
The definitions stated in Good Clinical Practice Guideline and the relevant legislation is
applicable.
3.
RESPONSIBILITIES
3.1. The responsibilities of the principal investigator or any investigator delegated by principal
investigator or the sponsor related to adverse event/reaction reporting are explained out in
Good Clinical Practice Guidance and the relevant legislation.
3.2. The Sponsor is responsible for the safety evaluation of the investigational product(s).
3.3. The Sponsor is responsible for promptly notifying all concerned investigator(s), the
relevant Ethics Committee and the Turkish Medicines and Medical Device Agency with
respect to all findings that could adversely affect the health of volunteers or have an impact
on the conduct of the trial or alter the authorization of the Ministry to continue the trial.
3.4. The Sponsor is responsible for providing systems and documentary standard operating
procedures to ensure that the necessary quality standards are in place at every stage of
documentation, data collection, validation, evaluation, archiving and reporting of the case.
3.5 Specific guidance related to notifications on clinical trials conducted with advanced
therapeutic medicinal products is contained in relevant guidelines.
4.
RECORDING,
EVALUATION
AND
REPORTING
OF
ADVERSE
EVENTS/REACTIONS
4.1. Processing adverse events to the case report form involves determination and evaluation of
data in all cases, and identification and processing of alerts requiring specific handling, and
investigation of all other cases.
4.2. Case report processing is related evaluation of data in individual cases, determination of
individual cases requiring specific handling, identification and processing of alerts, and
other data processing of collective cases.
4.3. Individual adverse events must be assessed by the principal investigator. This assessment
must contain an evaluation of causality between the severity of an adverse event and the
investigational product(s) and/or other accompanying treatments.
4.4. The Sponsor must maintain detailed record of all adverse events reported by the
investigator(s) and perform an evaluation with respect to seriousness, causality and
expectedness of each adverse event.
4.5. The sponsor must maintain detailed records of all adverse events and submit these records
whenever requested.
4.6. Upon request of the Turkish Medicines and Medical Devices Agency and/or the relevant
Ethics Committee, the Sponsor should submit detailed record of all adverse events which
have been reported by the relevant investigator.
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2. 4.7. Evaluation of an event for seriousness is generally made by the reporting investigator.
Seriousness must be defined by considering the comments given in Annex-1.
4.8. Evaluation of whether there is a reasonable probability of a causality relation is usually
done by the investigator. Causality must be determined by considering the comments given
in Annex-1.
4.9. All adverse events assessed by the investigator or by the supporter as “having a suspected
reasonable causative relation to the investigational product” are defined as adverse
reaction.
4.10. The causality evaluation given by the investigator must not be rejected by the sponsor. If
the sponsor disagrees with the causality evaluation of the investigator, the opinion of both
the Investigator and the Sponsor should be provided in the report.
4.11. The investigator is responsible for reporting to the sponsor all serious adverse events that
occur in volunteers in clinical trials. Unless specified otherwise in the protocol, the
investigator is not required to actively monitor the volunteers with regards to adverse
events after the study is terminated.
4.12. The investigator must report to the Sponsor as he/she was noticed of all serious adverse
events arising in the volunteer after the trial is terminated.
4.13. The investigator must promptly report to the Sponsor all serious adverse events not
contained in the protocol or the investigator’s brochure.
4.14. Adverse events and/or laboratory abnormalities identified in the protocol as critical to
safety evaluation will be reported to the Sponsor within the time periods specified in the
protocol by investigator.
4.15. The investigator will have to provide the relevant Ethics Committee, the Turkish Medicine
and Medical Device Agency and the sponsor any additional information requested
(particularly in the case of death of a volunteer).
4.16. The Sponsor will ensure that all relevant information about suspected unexpected serious
adverse reactions are recorded and reported to the relevant Ethics Committee and to the
Turkish Medicine and Medical Device Agency within the defined timelines; the
investigator should also be notified with this respect.
4.17. An adverse reaction will be considered “unexpected” where such adverse reaction’s
nature, seriousness or outcome of reaction does not correspond with the reference data.
4.18. Expectedness/Unexpectedness will be assessed based on the reference document, where
such reference document will be the Investigator’s Brochure for investigational products
not licensed/authorized in our country, the summary of product information and/or the
using instructions for the products registered in our country. The reference document will
be in the research protocol and enclosed with the application dossier.
4.19. Standards of confidentiality will always be maintained during notification and recording
procedures and the legislation related to data protection must be complied with.
4.20. All suspected unexpected serious adverse reactions (SUSARs) must be reported by the
sponsor on the following basis, specifying therein the trial coordination center and the full
name of the trial:
4.20.1.
All suspected unexpected serious adverse reactions arising during the trial as
related to the investigational product and the comparator products,
4.20.2.
SUSARs arising during a trial other than the one in question; SUSARs arising
during another trial conducted by the same Sponsor either in Turkey or in other
countries, or which are identified by spontaneous reports or a publication, or
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3. which are transmitted to the Sponsor by another regulatory authority; however,
SUSARs from other countries should be periodically reported at least every 6
(six) months as a line-listing.
4.21. Other safety issues also qualify for expedited reporting where they might materially alter
the current benefit-risk evaluation of an investigational product or might require a
modification of the administration of the investigational product or the overall conduct of
the trial, e.g.:
4.21.1. An increase or qualitative change in the incidence of an expected serious adverse
reaction, which is judged to be clinically important,
4.21.2. Post-study SUSARs that occur after the volunteer has completed a clinical trial and
are reported by the Investigator to the Sponsor,
4.21.3. New events related to the conduct of the trial or the development of the
investigational products and likely to affect the safety of the volunteers, including:
4.21.3.1. A serious adverse event which could be associated with the trial
procedures and which could modify the conduct of the trial,
4.21.3.2. A serious risk to the volunteer population such as lack of efficacy of an
investigational product used for the treatment of a life-threatening
disease,
4.21.3.3. A major safety finding (such as carcinogenicity) from a recently
completed animal study,
4.21.3.4. Any safety finding from another trial carried out by the same sponsor
with the same investigational product, which caused termination or
suspension of the trial.
4.21.4.
Recommendations of the Independent Data Monitoring Committee, if any,
applicable to safety of volunteers.
4.22. Expedited reporting is usually not required for non- serious adverse reactions
4.23. The Sponsor will inform all concerned investigators of information related to SUSARs that
could adversely affect the safety of volunteers.
4.24. The Investigator must notify, the information related to SUSARs that may affect the safety
of volunteers to the sponsor.
4.25. The Sponsor should report SUSAR’s that occur during a clinical trial associated with the
comparator product, to the relevant Ethics Committee and to Turkish Medicine and
Medical Device Agency, in case this product is authorized/licensed in our country.
4.26. Reporting the cases which are associated with placebo (e.g. a reaction dependent to an
excipient) is the responsibility of the Sponsor.
4.27. The Sponsor should, after initially receiving information about minimum criteria for
reporting, immediately notify Turkish Medicine and Medical Device Agency.
4.28. In each case follow-up information should be monitored and a report is completed as soon
as possible. The follow-up information should be forwarded by the sponsor to the relevant
Ethics Committee and to Turkish Medicine and Medical Device Agency within eight days
following to the arrival of receipt of follow-up information to the sponsor.
4.29. The sponsor must make all notices and reports related to safety issues to the relevant Ethics
Committee and to Turkish Medicine and Medical Device Agency within times specified in
the related legislation. Follow up information should also be reported. The sponsor must
also inform all investigators of the issue. However, SUSAR’s from other countries must be
reported at least once per 6 (six) months as line listing.
4.30. Information about the final description and evaluation of an adverse reaction report may
not be completed within the required timeframes for reporting. For due to the relevant
legislation, the initial reports will have to be notified within the time limits as soon as the
following minimum criteria are met:
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4. 4.30.1.
4.30.2.
4.30.3.
4.31.
4.32.
4.33.
4.34.
4.35.
4.36.
4.37.
4.38.
4.39.
4.40.
A suspected investigational product,
An identifiable volunteer (e.g. volunteer code number),
An adverse event assessed as serious and unexpected, and for which there is a
reasonable suspected causal relationship,
4.30.4.
An identifiable reporting source,
4.30.5.
The study protocol code, if applicable.
In case of incomplete information at the time of initial reporting, all the appropriate
information for an adequate analysis of causality should be sought from the reporter or
obtained from other sources. After receiving them, the Sponsor should report further
relevant information as follow-up reports. In certain cases, it may be appropriate to
conduct follow-up of the long-term outcome of a particular reaction.
The preferred method of reporting of SUSARs to be made to relevant Ethics Committee
and to Turkish Medicine and Medical Device Agency is via facsimile or by filing of a
written report. The specimen cover letter relating to notification of these reports is
illustrated in the website of the Turkish Medicine and Medical Device Agency.
The CIOMS-I (Council for International Organizations of Medical Sciences) form is the
standard format for notifications. However, other formats may also be used by representing
in the submission of research, but the basic information/data described in Annex 2 must be
provided in report.
All SUSARs originating from other countries should be reported to the relevant Ethics
Committee and to Turkish Medicine and Medical Device Agency at least once every six
months as a line-listing accompanied by a brief report by the sponsor highlighting the main
points of concern.
Any change increasing the risk to volunteers and any new circumstances that may
adversely affect the safety of the volunteers or the conduct of the trial should also be
reported to the relevant Ethics Committee and to Turkish Medicine and Medical Device
Agency as soon as possible, but no later than fifteen days.
Each SUSAR report (initial and follow-up reports) should contain such information that
will provide identification of sameness (duplicate) of reports. The identification code of the
volunteer in which SUSAR is observed should be unique in the same clinical trial
notwithstanding the number of SUSARs and the time at which they occurred. If duplicates
are identified by the Sponsor, the relevant Ethics Committee and Turkish Medicine and
Medical Device Agency should be informed appropriately.
The sponsor must provide information to all related investigators on findings that may
adversely affect the safety of the volunteers. If appropriate, such information may be
compiled in a SUSAR line listing. A brief summary of the safety profile that will be
obtained with respect to the investigational product must be added to the line listing.
In the case of blinded/masked trials, the line listing should contain the data related to all
SUSARs irrespective of the investigational product applied (e.g. active substance/placebo).
Therefore, blinding (masking) is protected if possible and applicable and the risk of
informing the investigators on the identity of the investigational product is prevented.
If a significant safety issue is detected during review of individual case report or collective
data, the sponsor must inform all investigators as fast as possible. A safety issue which has
an effect on the progress of the clinical trial or on the development project, including
temporary cessation of the trial or safety related corrections in the study protocol must also
be reported to investigators.
The expectedness of an adverse reaction is defined by reference safety data of the sponsor.
This must be done based on previously observed events and not what may be expected on
the pharmacological properties of a medical product.
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5. 4.41. Reference safety data is included in the brief product information (BPI)/instructions for use
(IU) or in the investigator brochure. The reference safety data must be referred to in the
cover letter presented in accompany with the application to Turkish Medicine and Medical
Device Agency and the relevant Ethics Committee.
4.42. If reference safety data is included in the investigator brochure, the brochure must contain
a section containing a clearly definition of such data. This section must contain information
on the nature and frequency of adverse reactions.
4. 43. Reference safety data may change during the conduct of the trial. This is a typical
significant change. For SUSAR reporting, the version of reference safety data at the time
of creation of SUSARs will be valid. Therefore, any change in reference safety data will
affect the number of adverse events that will be reported as SUSAR.
5.
REGULATION OF ADVERSE
BLINDED/MASKED TRIALS
EVENTS/REACTIONS
REPORTINGS
IN
5.1. It is desirable to retain the blindness for all volunteers prior to final study analysis.
However, a serious adverse event may become to be a serious adverse reaction; in this case
the blind may be broken only for that specific volunteer by the sponsor even it has not been
removed by the investigator.
5.2. If possible and appropriate, blindness should be maintained for staff members who are
responsible for data-analysis and interpretation of results upon conclusion of the study.
5.3. The blind of a single volunteer should only be removed by the investigator if relevant for
the safety of the volunteer.
5.4. In case of a blinded/masked study, the case should be assessed for seriousness,
expectedness/unexpectedness and causal relationship assuming that the tested
investigational medicinal product caused the reaction. If the case satisfies SUSAR criteria,
then the blinding should be removed and one of the following three options should be
applied:
5.4.1.
If the product administered to the volunteer is the investigational product
tested during the trial in question, the case should be reported as a SUSAR to
the Ethics Committee and to v
5.4.2.
If the product administered to the volunteer is an authorized/licensed
comparator product in our country, the adverse reaction should be reassessed
for expectedness/unexpectedness, according to the brief product information
and/or instructions for use.
5.4.3.
If the adverse reaction is unexpected, then it should be reported as SUSAR.
5.5. The sponsor will bear the responsibility of reporting SUSARs related to placebo after
unblinding.
6.
REGULATION OF ADVERSE EVENTS/REACTIONS REPORTING IN
CLINICAL TRIALS WITH DISEASES OF HIGH MORBIDITY AND HIGH
MORTALITY RATES
6.1. For clinical trials on diseases with high morbidity and/or high mortality rates, efficacy endpoints or mortalities can be reported as adverse reactions, and unblinding may jeopardize
the integrity of the clinical trial. In such cases, Turkish Medicine and Medical Device
Agency must be notified in advance and upon obtaining approval of Turkish Medicine and
Medical Device Agency, the adverse reaction may be agreed to be associated with the
disease and Turkish Medicine and Medical Device Agency and unblinding may be
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6. accepted. Methods for reporting such adverse reactions must be clearly defined in the
protocol.
6.2. In clinical trials on diseases with high morbidity and/or high mortality rates, sponsors are
encouraged to appoint an Independent Data Monitoring Committee (IDMC) in order to
survey the data on a regular basis, review safety data on the ongoing trial, to advice on
whether to continue, change or terminate the conductance of the trial.
6.3. The composition and operation of the Independent Data Monitoring Committee must be
defined in the protocol. The Independent Data Monitoring Committee’s opinion and
recommendations should be notified by the sponsor in a report to be submitted to the
Ethics Committee and to Turkish Medicine and Medical Device Agency. However
SUSARs, which are not efficacy endpoints, in the same study, have to be reported as
required.
7.
ANNUAL SAFETY REPORTS
7.1. In addition to the averse event/reaction reports, the sponsor will submit a safety report with
an appended cover letter as illustrated in website of the Ethics Committee and Turkish
Medicine and Medical Device Agency, incorporating all new available safety information
received during the reporting period on annual basis throughout the clinical trial period or
upon request.
7.2. Where the Sponsor carries out multiple trials with the same investigational product, the
annual safety report is to provide a brief general analysis of the actual safety profile of the
investigational product, relying on all available data and on the experience acquired during
all studies performed by the Sponsor.
7.3 The reference safety information which is valid at the beginning of the reporting period
should be submitted as appended to the report.
7.4 The reference safety information which is valid at the beginning of the reporting period is
considered as reference safety information during that reporting period.
7.5
In case of meaningful changes in the reference safety information within the reporting
period, those should be reported as line listing within the annual safety report.
7.6. The annual safety report must consist of three parts:
7.6.1. Part 1: A report on the volunteers’ safety in the concerned clinical trial.
7.6.1.1.
Along with his own view, the Sponsor should provide a concise
safety analysis and a benefit-risk evaluation of the clinical trial
concerned; it should describe all new and relevant findings, known
by the Sponsor (which is not previously included in the
Investigator’s brochure and/or in the instructions for use/brief
product information), related to the safety of treatment with the
investigational product, along with an analysis of their impact on
the volunteers concerned. If it is available the opinion and
recommendations of the Data Monitoring Committee should be
attached to the report.
7.6.1.2.
An analysis must be completed on potential impact on the clinical
trial population and also incorporating all available safety data, the
safety profile and the possible effect for the volunteer of
investigational product should be analyzed. The following points
should be considered:
Association with the dose and duration of the
treatment;
Reversibility of the effect;
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7. -
7.6.2.
Evidence of previously unidentified toxicity in
volunteers;
Increased frequency of toxicity;
Overdose and its treatment;
Interactions or other associated risk factors;
Any specific safety issue related to special populations,
such as the elderly, children or any other risk group;
Positive and negative experiences during pregnancy or
lactation;
Abuse;
Risks which might be associated with the investigation
or diagnostic procedures of the clinical trial;
Risks which might be associated with inadequate
quality of the investigational product.
7.6.1.3.
The report should also consider the assessment of investigations
results of non-clinical studies and other experience with the
investigational product that are likely to affect the volunteers'
safety.
7.6.1.4.
Measures for minimizing the risks suggested in past or currently
should be detailed, if any.
7.6.1.5.
Detailed justification must be provided as to whether or not it is
necessary to amend or update the protocol, the informed consent
form and the investigator brochure. This report will not replace the
request for protocol amendments.
7.6.1.6.
Finally, a risk-benefit assessment for the concerned trial should be
evaluated.
Part 2: Line-listings related to all suspected serious adverse reactions
emanating in the related clinical trial (including all SUSARs)
7.6.2.1.
The annual report should include a line-listing of all suspected
serious adverse reactions that were reported during the trial.
7.6.2.2.
The line-listing includes key information but not necessarily all the
details usually collected on individual cases.
7.6.2.3.
It should include each volunteer only once regardless of the number
of adverse reactions reported for the case, i.e., if there is more than
one adverse reaction in the same volunteer, they should all be
mentioned but the adverse reactions should be lined by the degree
of seriousness (sign, symptom or diagnosis) as judged by the
Sponsor. It is possible that the same volunteer may experience
different adverse reactions on different occasions. Such experiences
should be treated as separate reports. Under such circumstances,
the same volunteer might then be included in a line-listing more
than once. This should be specified on the line-listing.
7.6.2.4.
Cases should be presented as tables by body system (standard
system organ classification scheme).
7.6.2.5.
There should be one listing for each trial, but separate listings
might be provided for active comparator product or placebo, or
when appropriate and relevant for other reasons (e.g. different
formulations, indications or routes of administration in the same
trial).
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8. 7.6.3.
Part 3: Collective summary schedule of suspected serious adverse reactions
emanating in the related clinical trial
7.6.3.1.
In addition line listings of individual cases provided in Part 2,
summary tables of all serious adverse reaction should be provided
to allow an overview of the trial. Serious adverse reaction
definitions related to the signs, symptoms and/or diagnoses should
be provided in said tables. When the number of cases is less, a
narrative description would be more suitable.
7.6.3.2.
The aggregate summary tabulation should specify the number of
reports:
For each body system
For each adverse drug reaction term
For each treatment arm, if applicable (investigational
product, comparator product or placebo).
7.6.3.3.
The unexpected adverse reaction terms should be clearly identified
in the table. As an example, the table in annex 4 can be used.
77. The reporting timeframe for an annual report starts with the date on which Turkish
Medicine and Medical Device Agency authorizes the concerned clinical trial. Data lock
point should be prepared according to global clinical birth date (the date of approval for the
clinical trial conducted in Turkey using the related investigational product).
7.8. All data from this date until the end of first year thereafter should be included in the annual
safety report. The Sponsor should submit annual safety reports within 60 (sixty) days
thereafter the data lock point.
7.9. Even if the sponsor would be conducting several clinical trials with the same
investigational product, the safety report covering requisite information for all these trials
should be issued individually for each trial.
7.10. In the case of first human trials, bioequivalence and bioavailability studies and short term
metabolism or pharmacokinetic investigations, the safety report should be notified within
90 (ninety) days of the end of trial. This report should contain minimum line listing, if
appropriate, the aggregate summary tables, and an analysis of the volunteers’ safety.
8.
REGULATIONS ABOLISHED
The Guidance For Collection, Verification and Presentation of Reports of Adverse
Events/Reactions Arising in Clinical Drug Trials effected under approval no. 43659 dated
19.04.2013 have been abolished.
9.
EFFECT
These Guidelines will take effect at the date of approval.
10. ANNEXES
ANNEX 1: COMMENTS ON DEFINITIONS AND ABBREVIATIONS
Investigators Concerned: Investigators, which are actively involved in conductance of clinical
trials.
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9. Intense-Serious: The term “severe” is often used to describe the intensity (severity) of a specific
event as opposed to “serious,” which is based on patient/event outcome or action criteria.
ANNEX 2: SUSAR REPORT DATA
1.
2.
3.
4.
5.
6.
Clinical trial:
1.1. Protocol number (if any) of the clinical trial,
Volunteer’s details:
2.1. Code number assigned by the sponsor to the volunteer,
2.2. Volunteer’s initials,
2.3. Gender,
2.4. Age and/or date of birth,
2.5. Weight,
2.6. Height.
Suspected investigational product(s):
3.1. Name of the investigational product or brand name as reported,
3.2. International non-proprietary name (INN, International Nonproprietary Names),
3.3. Batch number,
3.4. Indication(s) for which suspect investigational product is used,
3.5. Dosage form and strength,
3.6. Daily dose and regimen (specify units e.g. mg, ml, mg/kg etc.),
3.7. Route of administration,
3.8. Starting date and time of day,
3.9. Stopping date and time, or duration of treatment
3.10. Unblinding: to be designated as yes/no/not applicable; if the answer is ‘yes’, the
results:
Other treatment(s)
4.1. For concomitant medicinal products (including non prescription ones) and nonmedicinal products, provide the same information as listed in article 3 above.
Causality Evaluation:
5.1. Investigator’s causality evaluation
5.2. Sponsor’s causality evaluation
5.3. Remarks.
Details of suspected Adverse Drug Reaction(s):
6.1. Full description of reaction(s) including body site and severity, as well as the criteria
for regarding the report as serious should be defined. In addition to a description of
the reported signs and symptoms, whenever possible attempts should be made to
establish a specific diagnosis for the reaction,
6.2. Reaction(s) in MedDRA terminology (lowest level term),
6.3. Onset date and time of the reaction,
6.4. Termination date and duration of the reaction,
6.5. De-challenge and re-challenge information,
6.6. Setting where the reaction occurred (e.g. hospital, out-patient clinic, home etc.),
6.7. Outcome: information on recovery and any sequel; what specific tests and/or
treatment may have been required and their results; for a fatal outcome, cause of
death and a comment on its possible relationship to the suspected reaction should be
provided. Any autopsy or other post-mortem findings should also be provided when
available,
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10. 7.
8.
6.8. Other information: anything relevant to facilitate evaluation of the case, such as
medical history including allergy, drug or alcohol abuse, family history, findings
from special investigations.
Information on reporter of event/suspected adverse reactions:
7.1. Name,
7.2. Address,
7.3. Telephone number,
7.4. Profession (specialty).
Sponsor and Other Data:
8.1. Date of this report,
8.2. Source of report: from a clinical trial/from the literature/other (if the source of report
is literature, provide a copy),
8.3. Date of first event report received by the sponsor,
8.4. Country in which the reaction occurred,
8.5. Type of report issued to with the authorities: initial or follow-up (first follow-up,
second follow-up, etc),
8.6. Name and address of sponsor/manufacturer/company,
8.7. Name, address, telephone number and facsimile number of contact person reporting
to the Sponsor,
8.8. Case reference number (sponsor’s/manufacturer’s identification number for the case.
This number must be the same for the initial and follow-up reports on the same case).
ANNEX 3: CONTENT OF LINE LISTING
The line listing should include the following information for each case:
1.
Full name of clinical trial,
2.
Volunteer’s identification number in the trial,
3.
Case reference number (Case-ID-Number) in the Sponsor’s safety database for
medicinal products,
4.
Country in which the case is occurred,
5.
Age and gender of trial volunteer,
6.
Daily dose of investigational medicinal product (dosage form and route of
administration),
7.
Date of onset of the adverse reaction (if not available, best estimation of time to
onset from therapy initiation. For an adverse reaction known to occur after cessation
of therapy, estimate of time lag if possible)
8.
Dates of treatment. (If not available, best estimate of treatment duration),
9.
Adverse reaction: description of the reaction as reported, and if possible, the
diagnosis as should be concluded from signs and symptoms,
10. Patient’s outcome (i.e. resolved sequel, death, and unknown).
11. Comments,
12. In the case of unblinded SUSARs, the assessment of results of unblinding as per the
reference document (investigator’s brochure) in force at the beginning of the period
covered by the report.
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11. ANNEX 4: EXAMPLE OF A COLLECTIVE SUMMARY TABULATION
Body system/ADR term
CNS
Hallucinations*
Confusion*
Verum
Placebo
Blinded
2**
1
2
1
0
0
------------------------------------------------------------------------------------
--------------------------------------------------------
--------------------------------------------------------
--------------------------------------------------------
Sub Total
CV
3
3
0
-----------------------------------------------------------------------------------
Sub-total
* Indicates an example of a SUSAR
** Number of reports by terms (signs, symptoms, and diagnoses).
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