Download Example 2 - Research

Risks and Benefits listed in examples are for example purposes only. See Form C
instructions to details of how to analyze risks in a research submission.
Risks and side effects related to the study drug XCDFR include:
Likely
(10 or more subjects out of 100)
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


Not Serious
Cough
Headache
Nausea
Tiredness (fatigue)
Serious

None
Less Likely
(Between 2-9 subjects out of 100)
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









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

Not Serious
Chest discomfort
Chest pain
Shortness of breath
Chills
Fever
Muscle spasms
Muscle pain
Leg (extremity) pain
Mouth or throat sores (stomatitis)
Decreased levels in blood magnesium
Loss of appetite (anorexia)
Decrease in sense of taste
Constipation
Diarrhea
Vomiting




Serious
Low red blood cells (anemia), which may
make you feel tired
Low platelets (cells that help blood clot)
(thrombocytopenia), which may increase
your chance of bleeding
Elevation in blood creatinine (a blood
measurement of the function of your
kidneys)
Raised blood pressure (hypertension)
Rare
(Less than 2 subjects out of 100)
Not Serious

None

Serious
Allergic reaction, which may be mild or
could be potentially life-threatening (could
cause death)
Risks and side effects related to Carboplatin include those which are:
Likely
(21-100 subjects out of 100)
Less Likely
(5-20 subjects out of 100)
Likely and Not Serious
 Nausea and vomiting
 Abnormal levels of certain
salts in the body like sodium
and potassium
Less Likely and Not Serious
 Rash
 Metallic taste
 Numbness and tingling in the
fingers and toes
 Hair loss
 Constipation or diarrhea
 Pain in your abdomen
 Temporary changes in vision
 Damage to the ear causing
hearing and balance
problems
 A feeling of weakness and/or
tiredness
 Inflammation and/or sores in
the mouth (and/or throat
and/or esophagus, the tube
that leads from the mouth to
the stomach) that may make
swallowing difficult and are
painful (painful mouth sores)
Likely and Serious
 Fewer red blood cells and
white
blood
cells
and
platelets in the blood
o A low number of red
blood cells can make you
feel tired and weak.
o A low number of white
blood cells can make it
easier to get infections.
o A low number of platelets
causes you to bruise and
bleed more easily.
Less Likely and Serious
 Allergic reactions (can be
severe and life-threatening
(could cause death), causing
difficulty in breathing and/or a
drop in blood pressure)
Rare but Serious
(Less than 5 subjects out of
100)
 Damage to the liver
 Damage to the kidney
 Leukemia later in life
Risks and side effects related to the Cisplatin include those which are:
Likely
(21-100 subjects out of 100)






Likely and Not Serious
Nausea and vomiting
Loss of appetite
Temporary and mild
increases in levels of certain
chemicals in the blood
because the kidneys are not
working as well as normal
Likely and Serious
Fewer red blood cells and
white blood cells and
platelets in the blood
o A low number of red
blood cells can make you
feel tired and weak.
o A low number of white
blood cells can make it
easier to get infections.
o A low number of platelets
cause you to bruise and
bleed more easily.
Abnormal levels of
magnesium in the body,
which may require that you
take extra magnesium by
mouth or in the vein
Damage to the ear, causing
difficulty in hearing highpitched sounds
Less Likely
(5-20 subjects out of 100)
Less Likely and Not Serious
 Abnormal levels of certain
salts in the body like sodium,
calcium, potassium and
phosphate
 Metallic taste
 Rash
 Numbness and tingling in
the fingers and toes
 Temporary changes in vision
 Inflammation and discomfort
in the vein through which the
medicine was given
Less Likely and Serious
Damage to the ear, causing
hearing loss, balance
problems and ringing in the
ears
 Elevation in the blood of
certain enzymes found in the
liver, which may indicate
liver irritation or damage

Rare but Serious
(Less than 5 subjects out of
100)
 Allergic reactions, which
may be severe and lifethreatening (could cause
death), causing difficulty in
breathing, rapid heart rate,
facial swelling and/or a drop
in blood pressure
 Damage to the kidneys,
which may be permanent
 Deafness
 Seizures
 Damage to the vision, which
could lead to blurred vision,
blue-green color blindness
and to loss of vision, which
usually goes away after
stopping the drug
 Decrease in muscle and
nerve reflexes that may
affect normal functions such
as walking
 Leukemia later in life
Risks and side effects related to Cyclophosphamide include those which are:
Likely
(21-100 subjects out of 100)
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



Likely and Not Serious
Loss of appetite
Nausea
Vomiting
Hair loss
Decreased ability of the body
to fight infection
Likely and Serious
 Fewer white blood cells
o A low number of white
blood cells can make it
easier to get infections.
 Absence or decrease in the
number of sperm, which may
be temporary or permanent,
which may decrease the
ability to have children
Less Likely
(5-20 subjects out of 100)
Less Likely and Not Serious
Abnormal hormone function,
which may lower the level of
salt in the blood
 Abdominal pain
 Diarrhea
 Bleeding and inflammation
of the urinary bladder
 Temporary blurred vision
 Nasal stuffiness with IV
infusions
 Skin rash
 Darkening of areas of the
skin and fingernails
 Slow healing of wounds
 Infections

Less Likely and Serious
Fewer red blood cells and
platelets in the blood
○ A low number of red
blood cells may make
you feel tired and weak.
○ A low number of
platelets may cause you
to bruise and bleed
more easily.
Absence or decrease of
monthly periods, which may
be temporary or permanent,
and which may decrease the
ability to have children









Rare but Serious
(Less than 5 subjects out of
100)
Heart muscle damage, which
may occur with very high
doses and which may be
fatal (could cause death)
Abnormal heart rhythms
Damage and scarring of lung
tissue, which may make you
short of breath
A new cancer or leukemia
resulting from this treatment
Damage or scarring of
urinary bladder tissue
Severe allergic reaction,
which can be life-threatening
(could cause death), with
shortness of breath, low
blood pressure, rapid heart
rate, chills and fever
Infertility, which is the
inability to have children
Procedure or component 6
Stem Cell Infusion
List each group exposed to this procedure
on a separate line.
(e.g., experimental, control, Arm A, Arm B, etc
Or state All Groups/Subjects
All Subjects
For each group, list the benefits of this procedure (either the procedure or a
monitoring procedure likely to contribute to the subject’s well being). If there are no
benefits, state “none”.
For this procedure or component, list the reasonably foreseeable risks
List the risks according to the probability (likely, less likely or rare) and magnitude (serious or not serious).
(include: 1) expected adverse events; 2) rare and serious adverse events; 3) all other psychological, social, legal harms)
Do not delete frequency. The need to know what to report promptly later = a requirement to estimate frequency (Instructions).
Not serious
Serious
Likely
Hypertension

Unusual breath and odor 
These risks are expected to occur in
from DMSO (substance 
Bradycardia
more than 20 out of 100 subjects.
used to protect the cells
during freezing)

Nausea

Vomiting

Facial flushing

Red colored urine
Not serious
Serious
Less likely

Diarrhea

Hypotension
These risks are expected to occur in 5- 
Headache

Abdominal cramps
20 subjects or less out of 100

Fever

Shortness of breath
subjects.

Chills

Chest tightness

Hypothermia
Serious
Rare

Bleeding
These risks are expected to occur in

Allergic reactions
less than 5 subjects out of 100

Heart rhythm disorder

Kidney failure

Infection

Engraft failure
Are all groups exposed to the risks listed
N/A (There is only one
Yes
No
above?
group)
If No, Describe: [Describe here]